[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640696":3},{"organization":4,"outcomesModule":7,"designInfo":90,"detailedDescription":37,"studyPopulation":37,"armGroups":101,"interventions":126,"overallOfficials":37,"centralContacts":137,"locations":143,"responsibleParty":311,"collaborators":37,"id":313,"slug":314,"hasResults":315,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":315,"sex":321,"minAge":322,"maxAge":37,"enrollmentInfo":323,"targetDuration":37,"studyType":326,"phases":327,"briefSummary":329,"conditions":330,"keywords":37,"overallStatus":146,"whyStopped":37,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},{"fullName":5,"class":6},"argenx","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A","free triiodothyronine: \\[fT3\\]; free thyroxine: \\[fT4\\]; ATDs: antithyroid drugs","up to 24 weeks (part A)",[14,18,21,24,27,31,35,38,41,44,48,50,53,56,59,63,67,70,73,77,80,83,87],{"measure":15,"description":16,"timeFrame":17},"Time to becoming euthyroid off ATDs in part A","ATDs: antithyroid drugs","Up to 24 weeks (part A)",{"measure":19,"description":20,"timeFrame":12},"Percentage of participants who are euthyroid and receiving MMI ≤5 mg\u002Fday or CBZ ≤7.5 mg\u002Fday at week 24 in part A","MMI: methimazole (also known as thiamazole); CBZ carbimazole",{"measure":22,"description":23,"timeFrame":17},"Percentage of participants with fT3 and fT4 levels below the ULN off ATDs at week 24 in part A","ULN : upper limit of normal; ATDs: antithyroid drugs",{"measure":25,"description":26,"timeFrame":12},"Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A","TRAb: anti-TSHR autoantibodies; ATDs: antithyroid drugs",{"measure":28,"description":29,"timeFrame":30},"Time to becoming euthyroid off ATDs and TRAb seronegative","ATDs: antithyroid drugs; TRAb: anti-TSHR autoantibodies","up to 24 weeks (part A) + up to 135 weeks",{"measure":32,"description":33,"timeFrame":34},"Time to becoming euthyroid and receiving an ATD dose of MMI ≤5 mg\u002Fday or CBZ ≤7.5 mg\u002Fday (part A)","ATDs: antithyroid drugs; MMI: methimazole (also known as thiamazole); CBZ carbimazole","up to 24 weeks",{"measure":36,"description":37,"timeFrame":30},"Time to becoming euthyroid",null,{"measure":39,"description":40,"timeFrame":12},"Time to having fT3 and fT4 levels within normal ranges among participants who had fT3 and\u002For fT4 more than the ULN at baseline (part A)","ULN : upper limit of normal",{"measure":42,"description":43,"timeFrame":12},"Time to having TSH within normal ranges among participants who have TSH lower than the LLN at baseline (part A)","TSH: thyroid-stimulating hormone; LLN: lower limit of normal",{"measure":45,"description":46,"timeFrame":47},"Percentage of participants who remain euthyroid off ATDs","ATDs: antithyroid drug","Up to 50 weeks (part B)",{"measure":49,"description":46,"timeFrame":47},"Percentage of participants who are euthyroid and receiving MMI ≤5 mg\u002Fday or CBZ ≤7.5 mg\u002Fday",{"measure":51,"description":46,"timeFrame":52},"Percentage of participants who remain euthyroid without ATDs","up to 98 weeks (part B)",{"measure":54,"description":46,"timeFrame":55},"Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months","up to 74 weeks (part B) + up to 135 weeks",{"measure":57,"description":46,"timeFrame":58},"Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS","up to 72 weeks (part C)",{"measure":60,"description":61,"timeFrame":62},"Incidence of AEs and SAEs","AEs: adverse events ; SAEs: serious adverse events","up to 135 weeks",{"measure":64,"description":65,"timeFrame":66},"Change in ThyPRO-39 over time","The Thyroid-Specific Patient-Reported Outcome Short Form (ThyPRO-39) 39 item version of the ThyPRO. Each item is related to a specific aspect of the participant's experience with their thyroid condition. Each item is scored on a 5-point Likert scale, and the scores are then transformed to a 0-to-100 scale. Higher scores indicate worse health status","Up to 135 weeks",{"measure":68,"description":69,"timeFrame":62},"Change in PROMIS-PF10a over time","The Patient-Reported Outcomes Measurement Information System Physical Function-10 item (PROMIS-PF10a) is a self- administered physical functioning assessment comprising 10 items that measure respondents' ability to perform common physical tasks. Scoring involves summing the numerical responses to each item; higher scores indicate better physical function.",{"measure":71,"description":37,"timeFrame":72},"Efgartigimod serum concentrations over time","up to 24 weeks (part A) + 72 weeks (part C)",{"measure":74,"description":75,"timeFrame":76},"Percentage change from baseline in total IgG levels in serum over time","IgG: immunoglobulin G","up to 98 weeks",{"measure":78,"description":79,"timeFrame":62},"Percentage change from baseline in TRAb serum levels over time","TRAb: anti-TSHR autoantibodies",{"measure":81,"description":82,"timeFrame":30},"Incidence of ADA against efgartigimod in serum","ADA: antidrug antibody(ies)",{"measure":84,"description":85,"timeFrame":86},"Incidence of antibodies against rHuPH20 in plasma","rHuPH20: recombinant human hyaluronidase PH20","up to 24 weeks (part A) + Up to 135 weeks",{"measure":88,"description":89,"timeFrame":30},"Incidence of NAb against efgartigimod in serum and rHuPH20 in plasma","NAb: neutralizing antibody(ies); rHuPH20: recombinant human hyaluronidase PH20",{"allocation":91,"interventionModel":92,"interventionModelDescription":37,"primaryPurpose":93,"observationalModel":37,"timePerspective":37,"maskingInfo":94},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":95,"maskingDescription":37,"whoMasked":96},"QUADRUPLE",[97,98,99,100],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[102,108,114,118,122],{"label":103,"type":104,"description":105,"interventionNames":106},"Part A - efgartigimod PH20 SC PFS","EXPERIMENTAL","Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.",[107],"Biological: efgartigimod PH20 SC",{"label":109,"type":110,"description":111,"interventionNames":112},"Part A - placebo PH20 SC PFS","PLACEBO_COMPARATOR","Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period.",[113],"Other: Placebo PH20 SC",{"label":115,"type":104,"description":116,"interventionNames":117},"Part B - efgartigimod PH20 SC PFS","Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.",[107],{"label":119,"type":104,"description":120,"interventionNames":121},"Part B - placebo PH20 SC PFS","Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.",[113],{"label":123,"type":104,"description":124,"interventionNames":125},"Part C - efgartigimod PH20 SC PFS","Participants, will receive efgartigimod PH20 SC PFS in the part C open-label treatment period",[107],[127,132],{"type":128,"name":129,"description":130,"armGroupLabels":131,"otherNames":37},"BIOLOGICAL","efgartigimod PH20 SC","Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)",[103,115,123],{"type":133,"name":134,"description":135,"armGroupLabels":136,"otherNames":37},"OTHER","Placebo PH20 SC","Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)",[109,119],[138],{"name":139,"role":140,"phone":141,"phoneExt":37,"email":142},"Sabine Coppieters, MD","CONTACT","857-350-4834","clinicaltrials@argenx.com",[144,162,178,191,202,218,231,244,258,272,286,299],{"facility":145,"status":146,"city":147,"state":37,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":156,"contacts":157},"TLC Diabetes and Endocrinology Clinic","RECRUITING","Surrey","V3T 2V6","Canada","CA",{"type":152,"coordinates":153},"Point",[154,155],-122.82509,49.10635,{"lat":155,"lon":154},[158],{"name":159,"role":140,"phone":160,"phoneExt":37,"email":161},"Akshay Jain, MD","+14032883224","oxyjain@gmail.com",{"facility":163,"status":146,"city":164,"state":37,"zip":165,"country":166,"countryCode":167,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"High Technology Hospital Medcenter LLC","Batumi","6000","Georgia","GE",{"type":152,"coordinates":169},[170,171],41.6306,41.64077,{"lat":171,"lon":170},[174],{"name":175,"role":140,"phone":176,"phoneExt":37,"email":177},"Inga Abesadze, MD","+995577137404","ingaabesadze777@gmail.com",{"facility":179,"status":146,"city":180,"state":37,"zip":181,"country":166,"countryCode":167,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"First Medical Clinic Ltd","Tbilisi","0102",{"type":152,"coordinates":183},[184,185],44.83412,41.69143,{"lat":185,"lon":184},[188],{"name":189,"role":140,"phone":37,"phoneExt":37,"email":190},"Maia Rekhviashvili, MD","rekhviashvili67@yahoo.com",{"facility":192,"status":146,"city":180,"state":37,"zip":193,"country":166,"countryCode":167,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"LTD MediClub Georgia","0160",{"type":152,"coordinates":195},[184,185],{"lat":185,"lon":184},[198],{"name":199,"role":140,"phone":200,"phoneExt":37,"email":201},"Nino Dolidze, MD","+995600000000","n.dolidze@mcg.ge",{"facility":203,"status":146,"city":204,"state":37,"zip":205,"country":206,"countryCode":207,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Aso Iizuka Hospital","Iizuka","820-8505","Japan","JP",{"type":152,"coordinates":209},[210,211],130.68678,33.63654,{"lat":211,"lon":210},[214],{"name":215,"role":140,"phone":216,"phoneExt":37,"email":217},"Tomoaki Inoue, MD","+81948223800","tinoueh9@aih-net.com",{"facility":219,"status":146,"city":220,"state":37,"zip":221,"country":206,"countryCode":207,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Nippon Medical School Musashikosugi Hospital","Kawasaki","211-8533",{"type":152,"coordinates":223},[224,225],139.71722,35.52056,{"lat":225,"lon":224},[228],{"name":229,"role":140,"phone":37,"phoneExt":37,"email":230},"Yuji Yamaguchi, MD","y-yamaguchi@nms.ac.jp",{"facility":232,"status":146,"city":233,"state":37,"zip":234,"country":206,"countryCode":207,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Hospital of University of Occupational and Environmental Health","Kitakyushu","807-8556",{"type":152,"coordinates":236},[237,238],130.85034,33.85181,{"lat":238,"lon":237},[241],{"name":242,"role":140,"phone":37,"phoneExt":37,"email":243},"Keiichi Torimoto, MD","torimoto@med.uoeh-u.ac.jp",{"facility":245,"status":146,"city":246,"state":37,"zip":247,"country":206,"countryCode":207,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"National Hospital Organization Kyoto Medical Center","Kyoto","612-0861",{"type":152,"coordinates":249},[250,251],135.75385,35.02107,{"lat":251,"lon":250},[254],{"name":255,"role":140,"phone":256,"phoneExt":37,"email":257},"Naotetsu Kanamoto, MD","+81756419161","kyotetsu@kuhp.kyoto-u.ac.jp",{"facility":259,"status":146,"city":260,"state":37,"zip":261,"country":206,"countryCode":207,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Nagasaki University Hospital","Nagasaki","852-8501",{"type":152,"coordinates":263},[264,265],129.88333,32.75,{"lat":265,"lon":264},[268],{"name":269,"role":140,"phone":270,"phoneExt":37,"email":271},"Ichiro Horie, MD","+81 095-819-7200","horie@nagasaki-u.ac.jp",{"facility":273,"status":146,"city":274,"state":37,"zip":275,"country":206,"countryCode":207,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Ito Hospital","Shibuya City","150-8308",{"type":152,"coordinates":277},[278,279],139.70665,35.6589,{"lat":279,"lon":278},[282],{"name":283,"role":140,"phone":284,"phoneExt":37,"email":285},"Natsuko Watanabe, MD","81334A27411","n-watanabe@ito-hospital.jp",{"facility":287,"status":146,"city":288,"state":37,"zip":289,"country":206,"countryCode":207,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"SHOWA Medical University Northern Yokohama Hospital","Yokohama","224-8503",{"type":152,"coordinates":291},[292,293],139.65,35.43333,{"lat":293,"lon":292},[296],{"name":297,"role":140,"phone":37,"phoneExt":37,"email":298},"Yo Kunii, MD","y-kunii@med.showa-u.ac.jp",{"facility":300,"status":146,"city":301,"state":37,"zip":302,"country":206,"countryCode":207,"cosmosGeoPoint":303,"geoPoint":306,"contacts":307},"Tottori University Hospital","Yonago","683-8504",{"type":152,"coordinates":304},[305,293],133.33333,{"lat":293,"lon":305},[308],{"name":309,"role":140,"phone":37,"phoneExt":37,"email":310},"Kazuhiko Matsuzawa, MD","k.matsuzawa@tottori-u.ac.jp",{"type":312,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100640696","phase-3-a-study-to-assess-efficacy-and-safety-of-efgartigimod-ph20-sc-pfs-in-adult-participants-with-graves-disease-100640696",false,"NCT07596849","A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.","A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs","VitaliThy","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.\n* Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels \\>=ULN (upper limit of normal) at screening\n* Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) \\\u003C0.1 mIU\u002FL at screening\n* Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening\n\nExclusion Criteria:\n\n* History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter)\n* History of RAI (radioactive iodine) therapy or received a total thyroidectomy\n* T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received \\\u003C6 weeks before screening\n* Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.\n* Graves' orbitopathy\u002FThyroid Eye Disease (GO\u002FTED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and\u002For planned corrective surgery\u002Firradiation or medical therapy during the study","ALL","18 Years",{"count":324,"type":325},230,"ESTIMATED","INTERVENTIONAL",[328],"PHASE3","The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.\n\nThe study consists of a part A double-blinded treatment period, a part B treatment\u002Fobservation period and a part C open-label treatment\u002Fobservation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment.\n\nThe total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fvitalithy",[331],"Graves Disease","2026-08-20",{"date":334,"type":335},"2026-08-21","ACTUAL",{"date":337,"type":335},"2026-06-10",{"date":339,"type":325},"2030-05",{"name":5,"class":6},12]