[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640696":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":38,"centralContacts":44,"locations":38,"responsibleParty":50,"collaborators":38,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":38,"enrollmentInfo":62,"targetDuration":38,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":38,"overallStatus":71,"whyStopped":38,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":38},{"fullName":5,"class":6},"argenx","INDUSTRY",[8,14,20,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Biological: efgartigimod PH20 SC",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Placebo PH20 SC",{"label":21,"type":10,"description":22,"interventionNames":23},"Part B - efgartigimod PH20 SC PFS","Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.",[13],{"label":25,"type":10,"description":26,"interventionNames":27},"Part B - placebo PH20 SC PFS","Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period.",[19],{"label":29,"type":10,"description":30,"interventionNames":31},"Part C - efgartigimod PH20 SC PFS","Participants, will receive efgartigimod PH20 SC PFS in the part C open-label treatment period",[13],[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BIOLOGICAL","efgartigimod PH20 SC","Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)",[9,21,29],null,{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":38},"OTHER","Placebo PH20 SC","Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)",[15,25],[45],{"name":46,"role":47,"phone":48,"phoneExt":38,"email":49},"Sabine Coppieters, MD","CONTACT","857-350-4834","clinicaltrials@argenx.com",{"type":51,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"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":63,"type":64},230,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70],"Graves Disease","NOT_YET_RECRUITING","2026-05-13",{"date":74,"type":75},"2026-05-19","ACTUAL",{"date":77,"type":64},"2026-06",{"date":79,"type":64},"2030-05",{"name":5,"class":6}]