[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thyroid-eye-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thyroid-eye-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,78,102,119,145,165,207,231,252,274,302,321,352,370],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100613336","phase-4-a-study-of-teprotumumab-n01-in-subjects-with-active-thyroid-eye-disease-100613336",false,"NCT07265258","A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease","A Multicenter, Randomized, Open-Label, Active-Controlled Phase IV Clinical Study to Evaluate the Efficacy and Safety of Teprotumumab N01 in the Treatment of Active Thyroid Eye Disease","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Written informed consent.\n2. Male or female subject between the ages of 18 and 80 years at screening.\n3. Weight between 45 kg and 100 kg.\n4. Moderate-to-severe active TED:\n\n   * CAS ≥ 3 in the study eye at screening and baseline;\n   * Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and\u002For inconstant or constant diplopia;\n   * ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;\n5. Exophthalmos ≥ 16 mm in the study eye at baseline.\n6. Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.\n\nExclusion Criteria:\n\nKey Exclusion Criteria:\n\nParticipants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):\n\n1. The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;\n2. Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;\n3. Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;\n4. Scheduled orbital radiotherapy at any time before baseline or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;\n5. Participants with poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) deviating from the normal reference range of the local laboratory by more than 50% at screening;\n6. Any other pre-existing disease, metabolic disorder, or physical examination or clinical laboratory abnormality that leads to a reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, affects the interpretation of study results, or places the participant at high risk of treatment complications;\n7. History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB at 0.5, 1, 2, and 4 kHz, or a bone conduction hearing threshold of ≥ 40 dB at any frequency);\n8. Poorly controlled diabetes mellitus (defined as glycosylated hemoglobin ≥ 8.0% at screening);\n9. Cumulative dose of glucocorticoids used to treat TED ≥ 1 g methylprednisolone equivalents at any time before baseline;\n10. Oral or intravenous glucocorticoids within 30 days prior to screening;\n11. Peribulbar\u002Fperiorbital injection of glucocorticoids within 90 days prior to screening;\n12. Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;\n13. Use of glucocorticoid eye drops\u002Fointments or use of non-steroidal immunosuppressant eye drops within 30 days prior to screening;\n14. Received TEPEZZA or Teprotumumab N01 Injection at any time before screening;\n15. Received CD20 antibody or interleukin-6 receptor (IL-6R) antibody at any time before screening;\n16. Have received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn, and TSHR) at any time before screening;\n17. Use of any other monoclonal antibody within 90 days prior to screening;\n18. Female participants in pregnancy or lactation.","ALL","18 Years","80 Years",{"count":20,"type":21},92,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).",[27],"Thyroid Eye Disease","RECRUITING","2026-08-11",{"date":31,"type":32},"2026-08-13","ACTUAL",{"date":34,"type":32},"2026-07-30",{"date":36,"type":21},"2028-12-30",{"name":38,"class":39},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":40},"100651537","phase-1-study-of-atorvastatin-and-its-effects-in-clinical-and-radiological-aspects-in-patients-with-moderate-to-severe-thyroid-eye-disease-100651537","NCT07762105","Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease","Adjunctive Atorvastatin in Moderate-to-severe Thyroid Eye Disease (SEMAR-TED: Structural, Biomarker Expression and Muscle Endpoints of Atorvastatin): Study Protocol for a Randomised, Open-label, Assessor-masked Controlled Trial","SEMAR-TED","Inclusion Criteria:\n\n* Age 18 to 75 years inclusive\n* Graves' orbitopathy graded moderate-to-severe by EUGOGO criteria\n* Active disease, clinical activity score ≥ 3 of 7\n* Rehabilitative orbital decompression anticipated after completion of glucocorticoid therapy, on the usual clinical grounds\n* Able to attend weekly infusion visits and complete follow-up to week 48\n* Written informed consent given\n* For women of childbearing potential, agreement to use effective contraception until week 24\n\nExclusion Criteria:\n\n* Sight-threatening disease at screening: dysthyroid optic neuropathy or corneal breakdown\n* Any other autoimmune disease requiring systemic immunosuppresion\n* Known hypersensitivity to atorvastatin or to any statin\n* Current or recent (within 3 months) use of any lipid-lowering drug\n* Any contraindication to orbital decompression\n* Any independent indication for lipid-lowering therapy: established atherosclerotic cardiovascular disease, more than one cardiovascular risk factor (diabetes mellitus, hypertension, obesity), or LDL cholesterol ≥ 190 mg\u002FdL\n* Systemic glucocorticoid or immunosuppressive treatment for orbitopathy within the preceding 3 months\n* Previous orbital irradiation or orbital surgery\n* Alanine or aspartate aminotransferase \\> 3 × upper limit of normal, or creatine kinase \\> 5 × upper limit of normal, at screening\n* Estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Pregnancy at screening (confirmed by a negative test before randomisation) or breastfeeding\n* Concomitant treatment with a strong CYP3A4 inhibitor\n* Any condition that, in the opinion of the investigator, would prevent completion of the trial","75 Years",{"count":51,"type":21},64,[53],"PHASE1","The trial tests the hypothesis that, in adults with active, moderate-to-severe Graves' orbitopathy, 24 weeks of oral atorvastatin 20 mg daily added to a standard 12-week course of intravenous methylprednisolone produces a greater reduction in extraocular muscle size than intravenous methylprednisolone alone, and that any such reduction is accompanied by lower expression of TSH receptor, IGF-1 receptor, PDGF receptor, PI3K\u002FAKT and miR-155 transcripts, and higher expression of miR-146a. The prespecified direction for miR-146a follows its reported suppression in CD4+ T cells in active disease \\[26\\]. Reported directions of change are compartment-specific and not unanimous, so the transcript analyses are exploratory.",[27,56,57],"Graves Ophthalmopathy","Graves Orbitopathy",[59,60,61,62,63,64,65,66,67],"graves orbitopapathy","thyroid eye disease","atorvastatin","statins","methylprednisolone","randomised controlled trial","orbital computed tomography","microRNA","graves ophthalmopathy","NOT_YET_RECRUITING","2026-08-07",{"date":31,"type":32},{"date":72,"type":21},"2026-08-30",{"date":74,"type":21},"2027-09-30",{"name":76,"class":77},"Banu Aji Dibyasakti","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":40},"100648264","phase-3-a-phase-iii-study-of-khn939-in-chinese-patients-with-moderate-to-severe-inactive-thyroid-eye-disease-100648264","NCT07720648","A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye Disease","A Multicenter, Randomized, Double-masked, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of KHN939 in the Treatment of Moderate-to-Severe Inactive Thyroid Eye Disease (TED) in China.","Halo-2","Inclusion Criteria:\n\n1. Aged 18-70 years (inclusive) at the time of signing the informed consent form (ICF), male or female\n2. Weight between 45 kg and 100 kg (inclusive)\n3. Diagnosed with moderate-to-severe inactive TED:\n\n   * proptosis ≥18 mm, accompanied by at least one of the following: (a) eyelid retraction ≥2 mm; (b) moderate to severe soft tissue involvement; (c) intermittent or continuous diplopia\n   * CAS ≤ 2 points in each eye\n   * CAS ≤ 2 in each eye for 6 months prior to screening (based on medical records); or meets all of the following criteria for ≥ 6 months prior to screening (based on patient self-report or medical records): no progression of proptosis, no new-onset or progressive TED-related diplopia, no new-onset inflammatory TED symptoms\n   * The time since initial TED diagnosis is ≥ 2 years and \\\u003C 10 years prior to screening (documented by patient history or medical records)\n4. Female participants of childbearing potential must have a negative serum pregnancy test during screening and agree to use an effective method of contraception from screening until 90 days after the last dose of the study drug. (Note: Women of non-childbearing potential, defined as surgically sterile or postmenopausal, are exempt.)Male participants must agree to use birth control from screening until at least 90 days after the dose of study drug.\n5. Able to comply with all protocol-required procedures, examinations, and symptom reporting\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the study drug formulation, or prior hypersensitivity to any monoclonal antibodies\n2. Proptosis at Day 1 (pre-dose) that has decreased by ≥2 mm relative to screening\n3. Ocular conditions:\n\n   * Prior or investigator-assessed diagnosis of dysthyroid optic neuropathy (DON) at screening\n   * Corneal involvement in the study eye without improvement after appropriate treatment\n   * Prior orbital radiotherapy or surgery for TED in the study eye (including orbital decompression, strabismus correction, eyelid correction)\n   * Requires immediate or planned ophthalmic surgical intervention during the study period\n   * Has any pre-existing ocular condition (e.g., high myopia, anticipated cataract surgery) that, as determined by the investigator, would preclude study participation or complicate the interpretation of study results\n4. Prior\u002Fconcomitant treatments:\n\n   * Use of oral or intravenous glucocorticoids within 30 days prior to screening\n   * Periorbital\u002Fperiocular corticosteroid injection within 90 days of screening\n   * Oral or IV non-steroidal immunosuppressants within 90 days of screening\n   * Corticosteroid or non-steroidal immunosuppressant eye drops within 7 days of screening\n   * Received teprotumumab or teprotumumab N01 at any time prior to screening\n   * Received anti-CD20 antibody therapy within 12 months prior to screening\n   * Received anti-interleukin-6 receptor (anti-IL-6R) antibody therapy within 6 months prior to screening\n   * Received any other investigational therapy for TED at any time prior to screening (including, but not limited to, biologics targeting IGF-1R, FcRn, or TSHR)\n   * Received any other monoclonal antibody therapy within 90 days prior to screening\n   * Need for selenium or vitamin supplementation for TED treatment from 21 days pre-dose through study end (multivitamins are permitted)\n5. Medical history\u002Fconditions:\n\n   * Medical conditions that contraindicate study drug use, including: suspected or confirmed inflammatory bowel disease (IBD), coagulopathy, Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 180 days, acute myocardial infarction (MI), unstable angina, or CABG\u002FPCI within 180 days, severe arrhythmia, or severe systemic infection\n   * Malignancy (treated or untreated) within 5 years prior to screening, except for the following cured or non-metastatic conditions: cutaneous squamous cell carcinoma (SCC) or basal cell carcinoma (BCC), cervical or prostate carcinoma in situ (CIS), papillary thyroid carcinoma\n   * Uncontrolled diabetes (HbA1c ≥8.0% at screening, or initiation of a new diabetes medication, or a \\>10% dose adjustment to an existing diabetes medication within 60 days prior to screening)\n   * Poorly controlled thyroid function: defined as FT3 or FT4 deviating ≥50% from local laboratory normal range (≥1.5×ULN or ≤0.5×LLN)\n   * Uncontrolled hypertension: defined as SBP ≥160 mmHg or DBP ≥100 mmHg; renal artery stenosis; or other evidence of clinically unstable blood pressure\n   * 12-lead ECG with a heart rate \\\u003C50 or \\>100 bpm and evidence of active cardiac disease; or any screening ECG abnormality that, in the investigator's opinion, confounds subsequent interpretation, particularly QTcF \\>450 ms in males or \\>470 ms in females\n6. Laboratory exclusions at screening:\n\n   * Alanine aminotransferase (ALT) \\>3 × ULN\n   * Aspartate aminotransferase (AST) \\>3 × ULN\n   * Serum creatinine(Cr) ≥1.5 × ULN, or glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² (MDRD formula)\n7. Clinically significant ear disease, prior ear surgery, hearing impairment, or abnormal pure-tone audiometry (defined as a mean bone conduction threshold ≥25 dB at 0.5, 1, 2, 4 kHz, or ≥40 dB at any frequency)\n8. Positive for HBsAg with HBV-DNA \\>1000 IU\u002FmL or currently receiving anti-HBV therapy; positive for HIV antibody or HCV antibody; or active syphilis\n9. Participation in any drug, vaccine, or device clinical trial within 3 months prior to screening, or currently within follow-up or within 5 half-lives of another study\n10. Female subjects who are pregnant or lactating\n11. Any other condition deemed by the investigator as inappropriate for study participation","70 Years",{"count":88,"type":21},117,[90],"PHASE3","This is a multicenter, randomized, double-masked, placebo-controlled Phase 3 study to evaluate the efficacy, safety, immunogenicity, and population pharmacokinetic (PopPK) characteristics of KHN939 in Chinese patients with moderate-to-severe inactive thyroid eye disease (TED). Approximately 117 participants who meet the study eligibility criteria will be randomized in a 2:1 ratio (stratified by smoking status) to receive 8 infusions of KHN939 or placebo q3W.",[27],"2026-07-22",{"date":95,"type":32},"2026-07-23",{"date":97,"type":21},"2026-08",{"date":99,"type":21},"2027-06",{"name":101,"class":39},"Beijing Kanghong Biological Medicine Co., Ltd.",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":118,"locationsCount":40},"100648225","phase-3-a-phase-iii-study-of-khn939-in-chinese-patients-with-moderate-to-severe-active-thyroid-eye-disease-100648225","NCT07720635","A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Active Thyroid Eye Disease","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of KHN939 in the Treatment of Moderate-to-Severe Active Thyroid Eye Disease (TED) in China","Halo-1","Inclusion Criteria:\n\n1. Aged 18-70 years (inclusive) at the time of signing the informed consent form (ICF), male or female\n2. Weight between 45 kg and 100 kg\n3. Diagnosed with moderate-to-severe active TED:\n\n   * Proptosis ≥18 mm, accompanied by at least one of the following: (a) eyelid retraction ≥2 mm; (b) moderate to severe soft tissue involvement; (c) intermittent or continuous diplopia\n   * CAS ≥ 3 points\n   * Duration of active TED symptoms ≤12 months prior to screening (documented by patient history or medical records)\n4. Female participants of childbearing potential must have a negative serum pregnancy test during screening and agree to use an effective method of contraception from screening until 90 days after the last dose of the study drug. (Note: Women of non-childbearing potential, defined as surgically sterile or postmenopausal, are exempt.) Male participants must agree to use birth control from screening until at least 90 days after the dose of study drug.\n5. Able to comply with all protocol-required procedures, examinations, and symptom reporting.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the study drug formulation, or prior hypersensitivity to any monoclonal antibodies\n2. Proptosis at Day 1 (pre-dose) that has decreased by ≥2 mm relative to screening\n3. CAS at Day 1 (pre-dose) that has decreased by ≥2 points relative to screening\n4. Ocular conditions:\n\n   * Prior or investigator-assessed diagnosis of dysthyroid optic neuropathy (DON) at screening\n   * Corneal involvement in the study eye without improvement after appropriate treatment\n   * Prior orbital radiotherapy or surgery for TED in the study eye (including orbital decompression, strabismus correction, eyelid correction)\n   * Requires immediate or planned ophthalmic surgical intervention during the study period\n   * Has any pre-existing ocular condition (e.g., high myopia, anticipated cataract surgery) that, as determined by the investigator, would preclude study participation or complicate the interpretation of study results;\n5. Prior\u002Fconcomitant treatments:\n\n   * Cumulative corticosteroid use for TED ≥1 g methylprednisolone equivalent. \\[Note: Participants receiving \\\u003C1 g and discontinued ≥30 days prior to screening are eligible\\]\n   * Corticosteroid use within 30 days of screening (except topical, intranasal, inhaled, or intra-articular)\n   * Periorbital\u002Fperiocular corticosteroid injection within 90 days of screening\n   * Corticosteroid or non-steroidal immunosuppressant eye drops within 7 days of screening\n   * Oral or IV non-steroidal immunosuppressants within 90 days of screening\n   * Prior anti-CD20 antibody, IL-6 receptor antibody, teprotumumab, or teprotumumab N01 at any time\n   * Any other investigational TED treatment (including IGF-1R or TSHR-targeting biologics) at any time\n   * Need for selenium or vitamin supplementation for TED treatment from 21 days pre-dose through study end (multivitamins are permitted)\n6. Medical history\u002Fconditions:\n\n   * Medical conditions that contraindicate study drug use, including: suspected or confirmed inflammatory bowel disease (IBD), coagulopathy, Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 180 days, acute myocardial infarction (MI), unstable angina, or CABG\u002FPCI within 180 days, severe arrhythmia, or severe systemic infection\n   * Malignancy (treated or untreated) within 5 years prior to screening, except for the following cured or non-metastatic conditions: cutaneous squamous cell carcinoma (SCC) or basal cell carcinoma (BCC), cervical or prostate carcinoma in situ (CIS), papillary thyroid carcinoma\n   * Uncontrolled diabetes (HbA1c ≥8.0% at screening, or initiation of a new diabetes medication, or a \\>10% dose adjustment to an existing diabetes medication within 60 days prior to screening)\n   * Poorly controlled thyroid function: defined as FT3 or FT4 deviating ≥50% from local laboratory normal range (≥1.5×ULN or ≤0.5×LLN)\n   * Uncontrolled hypertension: defined as SBP ≥160 mmHg or DBP ≥100 mmHg; renal artery stenosis; or other evidence of clinically unstable blood pressure\n   * 12-lead ECG with a heart rate \\\u003C50 or \\>100 bpm and evidence of active cardiac disease; or any screening ECG abnormality that, in the investigator's opinion, confounds subsequent interpretation, particularly QTcF \\>450 ms in males or \\>470 ms in females\n7. Laboratory exclusions at screening:\n\n   * Alanine aminotransferase (ALT) \\>3 × ULN\n   * Aspartate aminotransferase (AST) \\>3 × ULN\n   * Serum creatinine(Cr) ≥1.5 × ULN, or glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² (MDRD formula)\n8. Clinically significant ear disease, prior ear surgery, hearing impairment, or abnormal pure-tone audiometry (defined as a mean bone conduction threshold ≥25 dB at 0.5, 1, 2, 4 kHz, or ≥40 dB at any frequency)\n9. Positive for HBsAg with HBV-DNA \\>1000 IU\u002FmL or currently receiving anti-HBV therapy; positive for HIV antibody or HCV antibody; or active syphilis\n10. Participation in any drug, vaccine, or device clinical trial within 3 months prior to screening, or currently within follow-up or within 5 half-lives of another study\n11. Female subjects who are pregnant or lactating\n12. Any other condition deemed by the investigator as inappropriate for study participation",{"count":111,"type":21},60,[90],"This is a multicenter, randomized, double-masked, placebo-controlled Phase 3 study to evaluate the efficacy, safety, immunogenicity, and population pharmacokinetic (PopPK) characteristics of KHN939 in Chinese patients with moderate-to-severe active thyroid eye disease (TED). Approximately 60 participants who meet the study eligibility criteria will be randomized in a 2:1 ratio (stratified by smoking status) to receive 8 infusions of KHN939 or placebo q3W.",[27],{"date":95,"type":32},{"date":97,"type":21},{"date":99,"type":21},{"name":101,"class":39},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100626651","phase-2-an-open-label-rollover-trial-to-evaluate-the-efficacy-and-safety-of-amg-732-in-participants-with-thyroid-eye-disease-100626651","NCT07438405","An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease","An Open-label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-sponsored AMG 732 Studies and Are Primary Proptosis Non-responders or Who Relapsed During the Safety Follow-up","HAZEL 401","Inclusion Criteria\n\n1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Age ≥ 18 years at the time of signing informed consent for parent trial.\n3. Moderate-to-severe TED at the time of enrollment in parent trial and does not require immediate surgical ophthalmological intervention and is not planning corrective surgery\u002Firradiation during the rollover trial.\n4. Any worsening in thyroid status should be corrected to maintain euthyroid status for the entire rollover trial.\n5. Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.\n6. Participants with TED who completed Amgen-sponsored clinical trial of AMG 732.\n\nExclusion Criteria\n\n1. Prior orbital irradiation or decompression in the study eye.\n2. Prior adult strabismus surgery.\n3. Use of any steroid (intravenous, oral, or injected) and steroid eye drops or other non-steroid immunosuppressive agent, monoclonal antibody except the trial drug in parent trial within a protocol-specified number of months prior to the first injection of study drug.\n4. Glycated hemoglobin (HbA1c) \\> 6.5% and\u002For fasting glucose levels\\> 126 mg\u002FdL (\\> 7 mmol\u002FL) at screening.\n5. Malignant condition in the past 5 years or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study.\n6. Active liver or kidney disfunction at screening.\n7. Positive test for hepatitis B\u002FC or Human immunodeficiency virus (HIV) serology at screening.\n8. Known hypersensitivity to teprotumumab, AMG 732 or any other monoclonal antibody products.\n9. Participants have had an adverse event that is considered related to AMG 732 which required study drug interruption\u002Fdiscontinuation in the parent study\n10. Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing.\n11. Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug.\n12. History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).\n13. Other protocol-defined inclusion\u002Fexclusion criteria apply.","99 Years",{"count":129,"type":21},30,[131],"PHASE2","The main objective of this trial is to assess the efficacy of AMG 732 in participants with thyroid eye disease (TED) who are defined as primary nonresponders or relapsed during the safety follow-up in the parent trial (NCT06401044).",[27],[135,136],"Thyroid eye disease","AMG 732",{"date":95,"type":32},{"date":139,"type":32},"2026-05-07",{"date":141,"type":21},"2028-07-14",{"name":143,"class":39},"Amgen",8,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":40},"100640760","phase-1-a-study-of-ibi3031-in-participants-with-thyroid-eye-disease-100640760","NCT07622368","A Study of IBI3031 in Participants With Thyroid Eye Disease","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of IBI3031 in Participants With Thyroid Eye Disease","Key Inclusion Criteria:\n\n1. Written informed consent.\n2. Aged between 18 and 75 years at screening.\n3. Weight between 45 kg and 100 kg.\n4. Moderate-to-severe active TED:\n\n   * CAS ≥ 3 in the study eye at screening and baseline;\n   * Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and\u002For inconstant or constant diplopia;\n   * ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;\n5. Exophthalmos ≥ 18 mm in the study eye at baseline. (Only applicable to Stage 2)\n6. Participants must be clinically and biochemically euthyroid, or have mild hypothyroidism or mild-to-moderate hyperthyroidism at screening.\n7. Positive for Thyrotrophin Receptor Antibody (TRAb) at screening.\n8. No prior treatment with antithyroid medications and\u002For thyroid hormone replacement therapy, or having taken antithyroid medications and\u002For thyroid hormone replacement therapy on a stable dose for at least 6 weeks prior to the first dose, or having not been treated with antithyroid medications and\u002For thyroid hormone replacement therapy due to intolerable side effects for at least 6 weeks prior to the first dose.\n9. Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.\n\nKey Exclusion Criteria:\n\nParticipants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):\n\n1. The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;\n2. Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;\n3. Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;\n4. Presence of other non-TED ophthalmic diseases that may affect the interpretation of study results or the safety of participants as determined by the investigator (e.g., proptosis not primarily caused by TED);\n5. At screening, clinical or laboratory evidence of significant hypothyroidism (presence of clinical symptoms of hypothyroidism, or FT3 or FT4 (Free Thyroxine)\\\u003C0.5×lower limit of normal \\[LLN\\], or TSH\\>1.5×upper limit of normal \\[ULN\\]); or severe hyperthyroidism during the screening period (FT3 and FT4(Free Thyroxine)\\>2×ULN, or presence of thyroid storm).\n6. Other medical history and abnormal test results during the screening period that are judged by the investigator to be clinically significant, may cause the participant to fail to comply with the study protocol or complete the trial, or endanger safety, including but not limited to:\n\n   * History of hepatic insufficiency (Child-Pugh Class B or C) or liver cirrhosis; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2 × ULN at screening;\n   * Glomerular filtration rate (GFR) \\\u003C 60 ml\u002Fmin\u002F1.73 m2;\n   * Poorly controlled diabetes mellitus or hypertension;\n   * Confirmed or clinically suspected inflammatory bowel disease, gastrointestinal bleeding, or peptic ulcer disease.\n   * History of of chronic or recurrent infections; opportunistic infection within 180 days prior to screening;\n   * Positive for human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), non-specific syphilis antibody (e.g., RPR(Rapid Plasma Reagin), TRUST), hepatitis B virus surface antigen (HBsAg) or e-antigen (HBeAg), or interferon-gamma release assay (IGRA).\n   * History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB(decibe) at 0.5, 1, 2, and 4 kHz(kilohertz), or a bone conduction hearing threshold of ≥ 40 dB at any frequency);\n7. Scheduled radioactive iodine therapy or thyroidectomy at any time before screening or during the study;\n8. Scheduled orbital radiotherapy at any time before screening or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;\n9. Cumulative dose of glucocorticoids used to treat TED ≥ 1 g of methylprednisolone equivalents within 90 days prior to screening;\n10. Oral or intravenous glucocorticoids within 30 days prior to screening;\n11. Peribulbar\u002Fperiorbital injection of glucocorticoids within 90 days prior to screening;\n12. Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;\n13. Use of glucocorticoid eye drops\u002Fointments or use of non-steroidal immunosuppressant eye drops within 14 days prior to screening;\n14. Received antibody therapy targeting IGF-1R, TSHR, CD20(cluster of differentiation antigen 20), IL-6, or IL-6 receptor (IL-6R) at any time before screening;\n15. Received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn(neonatal Fc recepto), IL-6, or IL-6R) at any time before screening;\n16. Use of any other monoclonal antibody within 90 days prior to screening;\n17. Have received live vaccines within 180 days prior to screening, or plan to receive live vaccines during the study;\n18. Female participants in pregnancy or lactation.",{"count":153,"type":21},66,[53],"This is a multicenter, randomized, double-masked, placebo-controlled, single\u002Fmultiple-dose-escalation trial conducted in Chinese participants with Thyroid Eye Disease (TED), aiming to evaluate the safety and tolerability of IBI3031 administered via subcutaneous or intravenous injection.",[27],"2026-07-13",{"date":159,"type":32},"2026-07-14",{"date":161,"type":32},"2026-06-30",{"date":163,"type":21},"2027-12-28",{"name":38,"class":39},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":40},"100638476","clinical-validation-of-ai-based-quantitative-eye-movement-analysis-from-smartphone-9-gaze-videos-glandy-eom-100638476","NCT07623837","Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM)","Prospective Multicenter Observational Study for Clinical Validation of AI-Based Quantitative Eye Movement Analysis Using Smartphone-Recorded 9-Gaze Videos","GLANDY-EOM-VAL","Inclusion Criteria:\n\n* Adults who have reached the legal age of consent for research participation in the applicable jurisdiction.\n* Subjects with suspected or known ocular motility abnormalities.\n* Subjects who are able to understand and follow gaze instructions required for the 9-gaze examination, as judged by the investigator.\n* Subjects who are able to undergo facial video recording using a smartphone.\n* Subjects who provide written informed consent.\n\nExclusion Criteria:\n\n* Conditions that prevent reliable detection of ocular landmarks in video recordings (e.g., severe ptosis, corneal opacity, or significant occlusion of the eyes).\n* Ocular or facial conditions that, in the opinion of the investigator, may significantly interfere with image-based analysis.\n* Subjects who are unable to comply with study procedures.","22 Years",{"count":175,"type":21},1000,"OBSERVATIONAL","This prospective, multicenter, multinational observational study evaluates the clinical validity of an AI-based quantitative eye movement analysis system (Glandy EOM) that analyzes smartphone-recorded 9-gaze videos. Approximately 200 adults per site with suspected or confirmed ocular motility abnormalities will undergo a single study visit consisting of a standard clinical 9-gaze examination, an assistant-aided smartphone video recording, and a patient self-recorded video acquisition using a mobile application. Because the study population is defined by clinical suspicion or diagnosis of ocular motility abnormality rather than confirmed disease at enrollment, some participants may be clinically judged to have no abnormality on formal evaluation; such subjects remain part of the study population and are not considered healthy volunteers. AI-derived quantitative eye movement metrics (corneal center displacement in millimeters and angular deviation) will be compared with rater-derived measurements obtained from the same videos using a calibrated reference approach, and with clinician-assessed 9-gaze grading. The investigational device is used solely for video acquisition and analysis and does not influence clinical decision-making.",[179,180,181,27],"Ocular Motility Disorders","Strabismus","Extraocular Muscle Dysfunction",[183,184,185,186,187,188,189,190,191,180,192,193,194,195,196,197],"Ocular motility","Eye movement","9-gaze examination","Artificial intelligence","Smartphone video","Quantitative analysis","Corneal center displacement","Angular deviation","Extraocular muscle","Diplopia","Glandy EOM","Software as a Medical Device","SaMD","Digital health","Clinical validation","2026-05-28",{"date":200,"type":32},"2026-06-03",{"date":202,"type":21},"2026-07-01",{"date":204,"type":21},"2027-12-31",{"name":206,"class":39},"THYROSCOPE INC.",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":214,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":40},"100440187","evaluation-of-high-dose-prednisolone-pharmacokinetics-in-the-acute-and-chronic-setting-100440187","NCT05012033","Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting","EHD-Pred PK","Inclusion Criteria:\n\n* Aged 18 - 75 years\n* Male or female\n* Participants who are otherwise healthy enough to participate, as determined by pre-study medical history\n* Participants who are able and willing to give written informed consent to participate in the study\n* Group A only: Patients requiring acute (\\\u003C5 days) high dose (minimum 30mg) oral prednisolone therapy for antiinflammatory purposes in either an inpatient or outpatient setting.\n* Group B only: Minimum of 1 month duration of high dose prednisolone (\\>30mg) if in the chronic use group.\n* Group C only: Patients started on high dose methylprednisolone (\\>3 day course) or prolonged courses of dexamethasone.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.\n* Unable to give informed consent.\n* Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).\n* Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.\n* Pregnancy. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.\n* History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.",{"count":215,"type":21},120,"This is a pilot study to investigate serum prednisolone profiles in:\n\n* Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting.\n* Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone.\n\nThe study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone.\n\nThe study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.",[27,218,219,220,221],"Vasculitis","COPD Exacerbation Acute","Asthma","Inflammatory Disease","2026-03-24",{"date":224,"type":32},"2026-03-27",{"date":226,"type":32},"2023-04-12",{"date":228,"type":21},"2030-12-31",{"name":230,"class":77},"Imperial College London",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100628476","phase-1-an-efficacy-and-safety-study-of-ntb003-in-participants-with-thyroid-eye-disease-ted-100628476","NCT07462130","An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)","A Phase Ib\u002FII, Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)","Inclusion Criteria:\n\n* 1\\. Male or female subjects aged 18-75 years who have signed informed consent. 2.Body weight between 40 kg and 100 kg. 3.Clinical diagnosis of thyroid eye disease (TED): Active thyroid eye disease (TED): at least one eye with a CAS ≥ 3 and proptosis ≥ 3 mm above the upper limit of normal in that eye, and the subject's first onset of TED ocular signs\u002Fsymptoms (by subject report or medical records) occurred within 1 year prior to first study drug administration; Chronic Thyroid Eye Disease (TED) : bilateral CAS \\\u003C 3, and the first onset of TED ocular signs\u002Fsymptoms (by subject report or medical records) occurred \\> 12 months prior to first study drug administration.\n\n  4.Subjects clinically graded as having moderate-to-severe TED per the European Group on Graves' Orbitopathy (EUGOGO) classification at screening and baseline, typically accompanied by proptosis ≥ 3 mm above the upper limit of normal (normal range 12-16 mm). In addition, subjects should have one or more of the following features: eyelid retraction ≥ 2 mm, moderate or severe soft-tissue involvement, or intermittent\u002Fpersistent diplopia.\n\n  5.Do not require immediate ophthalmic surgical intervention and no corrective surgery or orbital radiotherapy is planned during the study.\n\n  6.Euthyroid with underlying thyroid disease controlled, or mild hypothyroidism or hyperthyroidism (defined as screening free triiodothyronine \\[FT3\\] and free thyroxine \\[FT4\\] levels \\\u003C 50% above or below the normal limits).\n\n  7.Subjects of childbearing potential must agree to use effective contraception during the trial and for at least 6 months after the last dose. Acceptable methods include complete abstinence, barrier contraception (e.g., condom), tubal ligation, intrauterine device, hormonal contraception (oral contraceptives, injections, transdermal patch, vaginal ring, or implant), or partner vasectomy.\n\n  8.Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to first study drug administration and must not be breastfeeding.\n\nExclusion Criteria:\n\n* 1\\. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period.\n\n  2.Within 6 months prior to screening, decrease in best corrected visual acuity (BCVA) attributable to TED optic neuropathy, defined as a loss of two lines of acuity, new visual field defect, or color vision defect secondary to optic nerve involvement.\n\n  3.Corneal abnormalities that, in the investigator's opinion, could affect efficacy assessments.\n\n  4.Prior or planned orbital radiotherapy or ocular surgery for TED, including orbital decompression, strabismus surgery, eyelid surgery, or similar procedures.\n\n  5.History of clinically significant hearing impairment, or abnormal pure-tone audiometry at screening.\n\n  6.History of inflammatory bowel disease, or clinically suspected inflammatory bowel disease (e.g., unexplained diarrhea with or without blood or rectal bleeding plus abdominal pain or cramping for \\>4 weeks; endoscopic or imaging evidence of enteritis\u002Fcolitis without other explanation).\n\n  7.Prior treatment with IGF-1 or IGF-1R-related agents. 8.Poorly controlled diabetes at screening. 9.Poorly controlled hypertension at screening. 10.AST or ALT \\> 3×ULN; or serum creatinine \\> 1.5×ULN; or platelet count \\\u003C 100 × 10\\^9\u002FL; or neutrophil count \\\u003C 2.0 × 10\\^9\u002FL at screening:.\n\n  11.Active hepatitis, defined as HBsAg positive with detectable HBV DNA above the local laboratory's lower limit of detection; or HCV antibody positive.\n\n  12.History of HIV infection or positive HIV antibody test. 13.Any active or suspected bacterial, viral, or fungal infection (e.g., severe common cold, viral syndrome, influenza-like illness) requiring intravenous antimicrobial therapy within 4 weeks prior to first dose.\n\n  14.Receipt of, or planned receipt during the study of, live or live-attenuated vaccines within 4 weeks prior to first dose.\n\n  15.Use of selenium, biotin, or traditional Chinese medicine therapies for TED (e.g., triptolide-containing compounds, Epimedium, polygonum cuspidatum, lotus seed heart, acupuncture, etc.) within 3 weeks prior to first dose or planned use during the study; combination multivitamins containing selenium and\u002For vitamins are permitted.\n\n  16.Use of oral or intravenous systemic glucocorticoids for any reason within 4 weeks prior to first dose; or topical ophthalmic glucocorticoid eye drops\u002Fointments for TED within 7 days prior to first dose. Use of topical glucocorticoids for non-TED indications (e.g., dermatologic conditions) before or during the study is allowed.\n\n  17.Use of oral or intravenous nonsteroidal immunosuppressants for TED (e.g., mycophenolate mofetil, cyclosporine, methotrexate, azathioprine, etc.) within 4 weeks prior to first dose; or topical ophthalmic nonsteroidal immunosuppressant eye drops for TED within 7 days prior to first dose.\n\n  18.Periocular\u002Forbital steroid injection within 3 months prior to first dose. 19.Treatment with anti-CD20 antibodies, interleukin-6 antibodies, or other biologic agents for TED within 3 months prior to first dose.\n\n  20.Botulinum toxin (or other chemical denervation agents) treatment for TED within 3 months prior to first dose.\n\n  21.Participation in another interventional clinical trial within 3 months prior to first dose.\n\n  22.Known or suspected allergy to the investigational product or any of its components, or prior history of hypersensitivity to other antibody drugs.\n\n  23.Any prior or concomitant disease or condition that, in the investigator's judgment, may interfere with trial compliance or affect evaluation of trial results (e.g., psychiatric disorders, recent acute cardiovascular or cerebrovascular events, history of treated or untreated malignancy within 5 years), or any other condition deemed by the investigator to make the subject unsuitable for participation.",{"count":239,"type":21},74,[53,131],"Multicentre, Phase Ib\u002FII Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease",[27],"2026-03-09",{"date":245,"type":32},"2026-03-10",{"date":247,"type":21},"2026-03-01",{"date":249,"type":21},"2028-03-30",{"name":251,"class":39},"Nanjing Chia-tai Tianqing Pharmaceutical",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":40},"100625467","evaluating-the-efficacy-and-safety-of-teprotumumab-n01-in-patients-with-thyroid-eye-disease-100625467","NCT07423013","Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.","Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease by FAPI PET\u002FCT and 5.0T-MRI","Inclusion Criteria:\n\n1. Able to comply with the study procedures and voluntarily sign the written informed consent form;\n2. Male or female subjects aged 18-80 years (inclusive) at screening;\n3. Body weight between 45 and 100 kg (inclusive);\n4. Meet internationally recognized diagnostic criteria for TED who are receiving teprotumumab N01 treatment；\n5. Diagnosed with TED at both the screening and baseline visits;\n6. Disease duration of less than 9 months\n\nExclusion Criteria:\n\n1. Poorly controlled thyroid function, defined as FT3 or FT4 deviating by more than 50% from the normal reference range;\n2. Receipt of radioactive iodine therapy within 3 months prior to screening;\n3. Thyroid dysfunction-related optic neuropathy, defined as any of the following occurring within the past 6 months due to optic nerve involvement: a decrease in best-corrected visual acuity (BCVA) of ≥2 lines, new visual field defects, or secondary color vision impairment;\n4. Corneal ulcer without improvement after treatment, as judged by the investigator;\n5. A decrease in CAS score of ≥2 points at baseline compared with screening;\n6. Prior treatment at any time before screening with monoclonal antibodies, including but not limited to anti-CD20 antibodies, anti-interleukin-6 antibodies, or anti-IGF-1R antibodies;\n7. Prior orbital radiotherapy for TED at any time before screening;\n8. Prior use at any time before screening of oral, injectable, topical, or inhaled glucocorticoids at a cumulative dose ≥1 g methylprednisolone equivalent;\n9. Receipt within 3 months prior to screening of oral or intravenous glucocorticoids (\\\u003C1 g methylprednisolone equivalent), or peribulbar or periocular glucocorticoid injections for TED;\n10. Use of any other immunosuppressive agents orally or intravenously within 3 months prior to screening;\n11. Vaccination within 1 month prior to screening;\n12. Hemoglobin \\\u003C 8.5 g\u002FdL, platelet count \\\u003C 100 × 10³\u002FµL, white blood cell count \\\u003C 3 × 10⁹\u002FL, absolute neutrophil count (ANC) \\\u003C 2 × 10⁹\u002FL, or absolute lymphocyte count \\\u003C 5 × 10⁸\u002FL;\n13. Acute or chronic, active or latent, recurrent bacterial, viral, fungal, or other infections, including but not limited to tuberculosis (positive T-SPOT or imaging findings), hepatitis B (HBsAg or HBcAb positive), hepatitis C (anti-HCV or HCV RNA positive), syphilis, herpes simplex, or herpes zoster;\n14. History of inflammatory bowel disease, gastrointestinal ulcer or diverticulitis, Cushing's disease, osteoporosis, or psychiatric disorders;\n15. History of immunodeficiency, including HIV infection or AIDS, other acquired or congenital immunodeficiency disorders, or organ transplantation;\n16. History of autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, or Sjögren's syndrome;\n17. History or current presence of malignancy (except for completely resected skin squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ without evidence of metastasis);\n18. Severe cardiovascular or cerebrovascular disease or related treatment history, including but not limited to stroke, transient ischemic attack, acute myocardial infarction, unstable angina, arrhythmia, heart failure, coronary artery bypass grafting, or percutaneous coronary intervention;\n19. Severe hepatic or renal insufficiency, defined as liver disease or abnormal liver function with ALT or AST ≥ 1.5 × the upper limit of normal, estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m², or serum creatinine ≥ the upper limit of normal;\n20. Poorly controlled diabetes mellitus, defined as fasting blood glucose (FBG) ≥ 7.0 mmol\u002FL or HbA1c ≥ 9.0% at screening, or initiation of new antidiabetic medication (oral or injectable) or a change in the dose of current antidiabetic medication by \\> 10% within 2 months prior to screening;\n21. Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, or adjustment of antihypertensive medication (dose or drug class) within 1 month prior to screening;\n22. Presence of uncontrolled disease conditions, including but not limited to asthma, psoriasis, or inflammatory bowel disease requiring glucocorticoid treatment at disease onset;\n23. History of hypersensitivity or allergy to other monoclonal antibodies;\n24. Alcohol, tobacco, drug, or chemical substance abuse; Alcohol abuse: weekly alcohol intake \\> 21 units for men or \\> 14 units for women (1 unit = 360 mL beer, or 150 mL wine, or 45 mL distilled spirits\u002FChinese liquor); Tobacco abuse: smoking index (number of cigarettes per day × years of smoking) \\> 400;\n25. Pregnant or breastfeeding female subjects, or male or female subjects planning pregnancy during the study or within 3 months after study completion, or unwilling to use effective contraception;\n26. Participation in another interventional clinical trial within 3 months prior to screening (for investigational drugs, within 5 half-lives, whichever is longer; vitamins and minerals excluded), or intention to participate in another clinical trial during the study;\n27. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial.",{"count":260,"type":21},50,[262],"NA","This is a prospective study designed to evaluate the efficacy and safety of Teprotumumab N01 in patients with Thyroid Eye Disease (TED). Eligible patients will receive Teprotumumab N01 and will be assessed using clinical and imaging parameters before and after treatment, with each patient serving as their own control. The primary endpoint is the overall response rate at Week 24.",[27],"2026-02-13",{"date":267,"type":32},"2026-02-20",{"date":269,"type":32},"2025-11-11",{"date":271,"type":21},"2027-05-31",{"name":273,"class":77},"Peking University Third Hospital",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":288,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100616696","phase-4-comparison-of-the-efficacy-and-safety-of-4-vs-8-treatments-with-tepezza-teprotumumab-for-thyroid-eye-disease-100616696","NCT07308964","Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease","A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of active Thyroid Eye Disease (TED).\n* Participants must be eligible for and have started the standard Teprotumumab (Tepezza) treatment protocol.\n* Participants must demonstrate a significant clinical response by the 4th infusion.\n* Ability to understand and provide signed written informed consent.\n\nExclusion Criteria:\n\n* Previous use of Teprotumumab or other biologic therapies for TED.\n* Participants who do not show early clinical response after the 4th infusion.\n* Participants who have any medical contraindications to Teprotumumab or any of its components.\n* Participants who have any known hearing problems.",{"count":282,"type":21},40,[24],"The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED).\n\nThe main question it aims to answer is:\n\n\\* Is a shorter course equally effective and safe for patients who respond well early in treatment.\n\nParticipants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.",[27,286,287],"Thyroid Eye Disease, TED","Thyroid Eye Disease (TED)",[60,289,290,291],"TED","Tepezza","Teprotumumab","2025-12-28",{"date":294,"type":32},"2025-12-30",{"date":296,"type":21},"2026-01",{"date":298,"type":21},"2028-05",{"name":300,"class":301},"Sheba Medical Center","OTHER_GOV",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":40},"100601651","phase-3-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-ibi311-in-subjects-with-inactive-thyroid-eye-disease-100601651","NCT07113262","A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease","A Multicenter, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease","Inclusion Criteria:\n\n1.At screening and baseline, the following diagnostic criteria for inactive TED were met:\n\n1. CAS of both eyes ≤ 2 points during the screening period and baseline;\n2. According to the subject's medical history, CAS of both eyes ≤ 2 points at least 6 months before screening, or according to the subject's chief complaint or medical history, with all of the following characteristics: no progression of proptosis and no new diplopia caused by TED at least 6 months before screening or no progression of diplopia caused by TED and no new inflammatory TED symptoms;\n3. According to the subject's chief complaint or medical history, the first TED diagnosis before screening was ≥ 2 years and \\\u003C 10 years.\n\n2.At baseline, the proptosis of the study eye was ≥20 mm. 3.If the subject is a female, she should be infertile or have a negative blood pregnancy test during the screening period and agree to take contraceptive measures from the screening period to 120 days after the last medication. If the subject is a male, he should agree to take contraceptive measures from the screening period to 120 days after the last medication.\n\nExclusion Criteria:\n\nSubjects who meet any of the following conditions will not be eligible to participate in this study:\n\n1. At baseline, the eyeball protrusion of the study eye decreased by ≥2 mm compared with the screening period;\n2. Subjects who have been previously diagnosed with DON, or who are determined by the investigator to have DON during screening (defined as: orbital MRI\u002FCT showing orbital apex crowding or optic nerve compression, and at least 2 of the following ophthalmological examination abnormalities that cannot be explained by other reasons: ① best corrected visual acuity \\[BCVA\\] \\\u003C 0.8 or BCVA decreased by ≥ 2 lines compared with before the onset; ② abnormal pupillary light reflex or relative pupillary afferent disorder; ③ color vision abnormalities; ④ optic disc edema and optic disc pallor on fundus examination; ⑤ visual field loss; ⑥ visual evoked potential with prolonged latency and\u002For decreased amplitude);\n3. Patients with corneal ulcers that are judged by the researchers to have no relief after treatment;\n4. Planned to receive orbital radiotherapy or surgical treatment for TED (including orbital decompression, strabismus correction, eyelid correction, etc.) at any time before baseline or during the study period;\n5. Poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) deviating from the normal reference value range of the local research center laboratory by more than 50% during screening;\n6. Any other diseases, metabolic disorders, abnormal physical examination or clinical laboratory test results, and there is reason to suspect that there may be diseases or conditions that may lead to contraindications to the use of the trial drug, affect the interpretation of the study results, or put the subjects at high risk of treatment complications, including but not limited to: confirmed or clinically suspected inflammatory bowel disease, coagulation disorders, history of acute cardiovascular and cerebrovascular diseases or treatment history within 180 days before screening(including but not limited to: cerebrovascular accident, transient ischemic attack, acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention \\[except diagnostic angiography\\], severe arrhythmia, etc.), history of malignant tumors treated or untreated in the past 5 years (except for skin squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or thyroid papillary carcinoma that have been successfully removed and have no evidence of metastasis), severe systemic infection, proptosis not caused by TED, etc.;\n7. During the screening period, any ear has: tinnitus or other history of hearing loss; or abnormal pure tone audiometry results (defined as average bone conduction hearing threshold ≥25 dB at 0.5, 1, 2, 4 kHz or bone conduction hearing threshold ≥40 dB at any frequency);\n8. At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\\>3×ULN, or with active hepatitis B (defined as HBsAg positive with HBV-DNA load\\>1000 IU\u002FmL), or receiving anti-hepatitis B virus treatment;\n9. At screening, glomerular filtration rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73m2 (MDRD formula: GFR = 186 × serum creatinine (mg\u002Fdl) - 1.154 × (age) - 0.203 × (0.742 \\[if female\\]), serum creatinine unit conversion: 1 μmol\u002FL = 0.0113 mg\u002FdL);\n10. Poorly controlled diabetes at screening (defined as glycated hemoglobin ≥8.0% at screening);\n11. At screening, patients have poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; renal artery stenosis; or evidence of unstable blood pressure (including orthostatic hypotension, etc.);\n12. During screening, the 12-lead ECG shows a heart rate of \\\u003C50 beats\u002Fmin or \\>100 beats\u002Fmin, the ECG indicates active heart disease, or the investigator believes that the ECG abnormality during screening will interfere with the interpretation of the ECG results during subsequent follow-up, especially excluding QTcF\\>500 ms;\n13. HIV antibody or HCV antibody positive or active syphilis (defined as non-specific syphilis antibody positive or requiring anti-syphilis treatment after consultation with the infectious disease department);\n14. Oral or intravenous glucocorticoids within 30 days before screening;\n15. Use of glucocorticoid eye drops\u002Feye ointment, or non-steroidal immunosuppressant eye drops within 30 days before screening;\n16. Periorbital\u002Fperiorbital injection of glucocorticoids within 90 days before screening;\n17. Any other non-steroidal immunosuppressants taken orally or intravenously within 90 days before screening;\n18. Received interleukin-6 receptor (IL-6R) antibody treatment within 180 days before screening;\n19. Received CD20 antibody treatment within 1 year before screening;\n20. Received IBI311 or TEPEZZA treatment at any time before screening;\n21. Have received any other TED treatment drugs under development at any time before screening (including but not limited to biological agents targeting IGF-1R, FcRn, and TSHR);\n22. Use of any other monoclonal antibody treatment within 90 days before screening;\n23. Participated in other interventional clinical trials within 90 days before screening (for drugs, within 5 half-lives, whichever is longer; excluding vitamins and minerals), or attempted to participate in other clinical trials during the study;\n24. Female subjects who are pregnant or lactating;\n25. Those who are known to be allergic to the study drug ingredients, or have a history of allergies to other monoclonal antibodies; Those who are considered by the researchers to be unsuitable for participating in this clinical trial due to other reasons.",{"count":310,"type":21},111,[90],"A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.",[27],"2025-11-13",{"date":316,"type":32},"2025-11-17",{"date":318,"type":32},"2025-09-10",{"date":204,"type":21},{"name":38,"class":39},{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100524715","phase-2-extension-study-of-two-doses-of-linsitinib-in-subjects-with-active-moderate-to-severe-thyroid-eye-disease-ted-100524715","NCT06112340","Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","Inclusion Criteria:\n\n* Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (\\\u003C 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301\n* Subject has not received any treatment for TED since Week 24 of VGN-TED-301\n* Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \\[FT4\\] and free triiodothyronine levels \\[FT3\\] \\\u003C50% above or below the normal limits) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial\n* Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study\n\nExclusion Criteria:\n\n* The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.",{"count":329,"type":21},75,[131,90],"The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.",[27,57,333,334,335,56,336,337,338,339,340,341],"Endocrine System Diseases","Eye Diseases","Thyroid Associated Ophthalmopathy","Thyroid Diseases","Orbital Diseases","Proptosis","IGF1R","Exophthalmos","Hashimoto","2025-02-24",{"date":344,"type":32},"2025-02-25",{"date":346,"type":32},"2023-10-11",{"date":348,"type":21},"2026-06",{"name":350,"class":39},"Sling Therapeutics, Inc.",2,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":358,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":369,"locationsCount":40},"100543740","exploring-the-value-of-18f-alf-fapi-petct-in-assessing-the-activity-of-thyroid-eye-disease-100543740","NCT06359795","Exploring the Value of 18F-AlF-FAPI PET\u002FCT in Assessing the Activity of Thyroid Eye Disease","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Patients diagnosed with TED;\n3. Complete understanding and voluntary participation in this study, with the signing of an informed consent form.\n\nExclusion Criteria:\n\n1. Severe liver or kidney dysfunction;\n2. Inability to maintain a supine position for 5 minutes to cooperate with the examination;\n3. Suffering from claustrophobia or other psychiatric disorders;\n4. Patients planning pregnancy or in the prenatal or lactation period;\n5. Other conditions deemed unsuitable for participation in the trial by the investigator.",true,{"count":260,"type":21},[262],"FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET\u002FCT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET\u002FCT may be superior to 99mTc-DTPA SPECT\u002FCT for the diagnosis, therapy response assessment, and follow-up of TED.",[27],"2024-04-07",{"date":365,"type":32},"2024-04-11",{"date":367,"type":32},"2023-12-15",{"date":204,"type":21},{"name":273,"class":77},{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":291,"eligibilityCriteria":375,"healthyVolunteers":358,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":40},"100537249","the-effect-of-teprotumumab-on-thyroid-eye-disease-and-thyroid-dysfunction-100537249","NCT06275373","The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction","Inclusion Criteria:\n\n* only DOD beneficiaries\n* adult patients 18 years of age or older\n* adult patients with proptosis, ocular\u002Forbital pain, diplopia, lid\u002Forbital edema, or lid\u002Forbital erythema associated with autoimmune thyroid disease\n\nExclusion Criteria:\n\n* Patients with evidence of compressive optic neuropathy necessitating urgent orbital decompression or external beam radiation\n* patients with a history of uncontrolled diabetes mellitus\n* patients with a history\u002Fdiagnosis of uncontrolled inflammatory bowel disease\n* patients under age 18 years\n* patients who are pregnant or trying to become pregnant.",{"count":377,"type":21},100,"This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid\u002Forbital edema, or lid\u002Forbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).",[27,56,380],"Graves Disease",[135,382,383],"Graves ophthalmopathy","Graves disease","2024-02-16",{"date":386,"type":32},"2024-02-23",{"date":388,"type":32},"2021-05-12",{"date":390,"type":21},"2027-12-12",{"name":392,"class":393},"Walter Reed National Military Medical Center","FED"]