[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allergen-immunotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allergen-immunotherapy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100648780","phase-1-phase-1-first-in-human-fih-open-label-single-arm-ascending-dose-study-to-assess-the-safety-tolerability-and-preliminary-immunogenicity-of-iti-9001-in-japanese-patients-with-japanese-red-cedar-jrc-pollinosis-100648780",false,"NCT07726147","Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis","Phase 1, First in Human (FIH), Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis: A Two-part Design Consisting of an Open-Label, Single-Arm Part A and a Randomized, Double-Blind, Part B","Inclusion Criteria:\n\n1. Signed and dated informed consent form (ICF)\n2. Female of non-childbearing potential or male aged 18-65 years (inclusive). Women are not considered to be of childbearing potential if they have had a hysterectomy or tubal ligation, or are postmenopausal (≥12 months without menstruation, or FSH in postmenopausal range for women \\\u003C55 years)\n3. Confirmed JCP sensitivity by positive skin prick test (wheal diameter ≥3 mm)\n4. Confirmed JCP sensitivity by ImmunoCAP (serum JCP-specific IgE ≥ class 2)\n5. ≥2 year history of seasonal rhinoconjunctivitis symptoms requiring medication upon JCP exposure\n6. Contraception requirements: \\\u003Cbr\\> a. Women of non-childbearing potential: negative serum pregnancy test ≤3 days before first dose \\\u003Cbr\\> b. Men: surgically sterile, or agree to abstinence or use 2 highly effective methods of contraception during study and for 3 months after last dose if partner is of childbearing potential (male condom + oral hormonal contraceptives, intrauterine device, or intrauterine hormone-releasing system)\n7. No significant ischemic heart disease or myocardial infarction within 6 months before first study drug administration; adequate cardiac function at screening (QTcF ≤470 msec for females or ≤450 msec for males; average of triplicate ECGs). Participants with ventricular arrhythmia assessed case-by-case\n8. Willing and able to participate and comply with all study procedures\n\nExclusion Criteria:\n\n1. Women of childbearing potential (do not meet inclusion criterion #2)\n2. Respiratory function: \\\u003Cbr\\> a. Fever ≥38°C (100.4°F) on day of study drug administration \\\u003Cbr\\> b. FEV1 \\\u003C80% as predicted on spirometry \\\u003Cbr\\> c. Current smoker\u002Ftobacco user \\\u003Cbr\\> d. History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)\n3. Contraindications: \\\u003Cbr\\> a. Known allergy to ITI-9001 components \\\u003Cbr\\> b. Contraindication to intramuscular injections or blood draws \\\u003Cbr\\> c. History of intolerance or severe allergic reaction to previous immunotherapy \\\u003Cbr\\> d. History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines)\n4. Prior\u002Fconcurrent treatments: \\\u003Cbr\\> a. Participation in another therapeutic clinical trial within 30 days before screening \\\u003Cbr\\> b. Prior or current immunotherapy for JCP \\\u003Cbr\\> c. Specific or nonspecific immunotherapy within 1 year prior to screening \\\u003Cbr\\> d. Biologics (e.g., anti-IgE, anti-IL-5, anti-TNFα) \\\u003Cbr\\> e. mRNA vaccine within 28 days before first study drug administration \\\u003Cbr\\> f. Live vaccine within 28 days or inactivated\u002Ftoxoid vaccine within 7 days before first study drug administration \\\u003Cbr\\> g. Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical) \\\u003Cbr\\> h. Inability\u002Funwillingness to discontinue beta-blockers up to 48 hours before first study drug administration and during the study \\\u003Cbr\\> i. Inability\u002Funwillingness to comply with washout periods for antihistamines and other allergy medications (per Table 3)\n5. Medical history\u002Fcomorbidities: \\\u003Cbr\\> a. Clinically significant abnormalities on physical exam, labs, or medical history that jeopardize safety or validity of results (except HEENT findings consistent with allergic rhinitis) \\\u003Cbr\\> b. Malignant tumor diagnosed or treated within 5 years prior to first study drug administration (except adequately treated non-melanoma skin cancer or carcinoma in situ) \\\u003Cbr\\> c. Congenital or acquired immune deficiency or suppression (e.g., malignancy, infection, chemotherapy, radiation, corticosteroids) \\\u003Cbr\\> d. History of organ transplant, hematologic malignancy, or autoimmune disease \\\u003Cbr\\> e. History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration \\\u003Cbr\\> f. Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF \\\u003C45% \\\u003Cbr\\> g. History of myocarditis or pericarditis \\\u003Cbr\\> h. Risk factors for torsades de pointes or use of medications known to prolong QT\u002FQTc (except low-risk premedications) \\\u003Cbr\\> i. Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease \\\u003Cbr\\> j. HIV\u002FAIDS, hepatitis B, or hepatitis C infection \\\u003Cbr\\> k. Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration \\\u003Cbr\\> l. Symptomatic overlap with JRC pollinosis requiring regular medications \\\u003Cbr\\> m. Alcohol or drug abuse within 1 year before screening or current dependence","ALL","18 Months","65 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase 1, first-in-human clinical trial to test a new treatment called ITI-9001 for people with allergies to Japanese Red Cedar (JRC) pollen-a common cause of seasonal allergies in Japan. The main goals are to find out if ITI-9001 is safe, how well people tolerate it, and whether it can trigger helpful immune responses.",[27],"Allergen Immunotherapy",[29,30,31,32],"Japanese Red Cedar (JRC) pollinosis","Japanese Cedar Pollen (JCP) allergy","seasonal allergic rhinitis","self-amplifying RNA (saRNA)","RECRUITING","2026-07-20",{"date":36,"type":37},"2026-07-24","ACTUAL",{"date":39,"type":37},"2026-06-20",{"date":41,"type":21},"2028-02",{"name":43,"class":44},"Immunomic Therapeutics, Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100541523","allergy-asthma-and-atopic-eczema-in-finland-100541523","NCT06330974","Allergy, Asthma, and Atopic Eczema in Finland","Allergy, Asthma, and Atopic Eczema in Finland - A Nationwide Study on Prevalence, Comorbidities, Treatment and Economic Burden","FinnATOPY","Inclusion\u002FExclusion Criteria ---\\> https:\u002F\u002Fwww.finnatopy.fi\u002Fmethods",{"count":55,"type":21},2000000,"7 Years","OBSERVATIONAL","The summary is available at --\\> https:\u002F\u002Fwww.finnatopy.fi\u002Fsummary",[60,61,62,63,64,27],"Asthma","Asthma in Children","Allergy","Rhinitis, Allergic","Atopic Dermatitis","NOT_YET_RECRUITING","2024-03-19",{"date":68,"type":37},"2024-03-26",{"date":70,"type":21},"2024-10",{"date":72,"type":21},"2034-12",{"name":74,"class":75},"Tampere University","OTHER"]