[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648627":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":116,"collaborators":36,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":36,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":52,"whyStopped":36,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Biogen","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants will receive multiple IV doses of placebo.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Felzartamab or Placebo","EXPERIMENTAL","Participants will receive multiple IV doses of felzartamab or placebo.",[19,13],"Drug: Felzartamab",{"label":21,"type":16,"description":22,"interventionNames":23},"Felzartamab","Participants will receive multiple IV doses of felzartamab.",[19],[25,34],{"type":26,"name":21,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Administered IV",[21,15],[30,31,32,33],"BIIB148","MOR202","MOR03087","TJ202",{"type":26,"name":9,"description":27,"armGroupLabels":35,"otherNames":36},[15,9],null,[38],{"name":39,"affiliation":5,"role":40},"Medical Director","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"US Biogen Clinical Trial Center","CONTACT","866-633-4636","clinicaltrials@biogen.com",{"name":48,"role":44,"phone":36,"phoneExt":36,"email":46},"Global Biogen Clinical Trial Center",[50,70,85,100],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"AME Clinical Research","RECRUITING","Los Angeles","California","92647","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-118.24368,34.05223,{"lat":62,"lon":61},[65,67],{"name":36,"role":44,"phone":66,"phoneExt":36,"email":36},"714-375-5970",{"name":68,"role":69,"phone":36,"phoneExt":36,"email":36},"Chris Tsimerekis","PRINCIPAL_INVESTIGATOR",{"facility":71,"status":52,"city":72,"state":73,"zip":74,"country":56,"countryCode":57,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Asheville Clinical Research","Asheville","North Carolina","28803",{"type":59,"coordinates":76},[77,78],-82.55402,35.60095,{"lat":78,"lon":77},[81,83],{"name":36,"role":44,"phone":82,"phoneExt":36,"email":36},"828-579-2273",{"name":84,"role":69,"phone":36,"phoneExt":36,"email":36},"Lauren Bernstein",{"facility":86,"status":52,"city":87,"state":88,"zip":89,"country":56,"countryCode":57,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"M3 Wake Research - Dallas","Dallas","Texas","75246",{"type":59,"coordinates":91},[92,93],-96.80667,32.78306,{"lat":93,"lon":92},[96,98],{"name":36,"role":44,"phone":97,"phoneExt":36,"email":36},"469-297-3074",{"name":99,"role":69,"phone":36,"phoneExt":36,"email":36},"Carlos Arauz-Pacheco",{"facility":101,"status":52,"city":102,"state":36,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Solace Clinical Research - Puerto Rico","Bayamón","00959","Puerto Rico","PR",{"type":59,"coordinates":107},[108,109],-66.15572,18.39856,{"lat":109,"lon":108},[112,114],{"name":36,"role":44,"phone":113,"phoneExt":36,"email":36},"787-425-4881",{"name":115,"role":69,"phone":36,"phoneExt":36,"email":36},"Carmen Pizarro",{"type":117,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100648627","phase-2-a-study-to-learn-about-the-effects-of-felzartamab-on-thyroid-function-and-its-safety-in-adults-with-graves-disease-ages-18-to-75-years-old-100648627",false,"NCT07722546","A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old","A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants With Graves' Disease","GRAVITATE","Key Inclusion Criteria:\n\n* Have active disease and are thyroid-stimulating hormone receptor antibodies (TRAb) positive, defined as:\n\n  * Free thyroxine (FT4) and free triiodothyronine (FT3), within the reference range,\n  * suppressed thyroid-stimulating hormone (TSH)\n  * TRAb levels \\> upper limit of normal (ULN)\n* Participants must be receiving stable dose of anti-thyroid drugs (ATD) for at least 12 weeks prior to randomization.\n* Must agree to refrain from blood product donation from Screening through end of study. If a participant terminates early from the study, they must refrain from blood product donation for 90 days following the last dose of study drug.\n\nKey Exclusion Criteria:\n\n* History of thyroidectomy or radioactive iodine therapy.\n* ATD dose change within 12 weeks prior to Day1, or anticipated need for dose adjustment prior to randomization (except for protocol-defined safety management).\n* Active, moderate-to-severe, or sight threatening thyroid eye disease (TED) (as assessed by the clinical activity score \\[CAS\\]), or requirement for imminent or ongoing TED-directed therapy (e.g., systemic glucocorticoids, biologic therapy, orbital radiation, surgery).\n* Any history of malignancy within 5 years prior to Screening except for adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.\n* History of hyperthyroidism not caused by GD (e.g. toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis) and\u002For history or presence of thyroid storm.\n* Type 1 diabetes and type 2 diabetes mellitus with hemoglobin A1c (HbA1c) \\> 8%.\n* Known or suspected history of hypersensitivity to felzartamab or its excipients.\n* Use of immunosuppressive therapy within 5 half-lives\u002F12 weeks of Screening.\n* Co-existing autoimmune diseases that require systemic immunosuppressants (e.g., cyclosporine, methotrexate, biologics, monoclonals).\n* Prior use of an anti-Neonatal Fragment Crystallizable Receptor (FcRn) therapy or intravenous immunoglobulin (IVIg) within 6 months of the last dose prior to Screening.\n* Any condition that requires chronic use of high-dose steroids.\n\nNOTE: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","75 Years",{"count":130,"type":131},60,"ESTIMATED","INTERVENTIONAL",[134],"PHASE2","In this study, researchers will learn more about the use of felzartamab in participants with Graves' Disease, also known as GD. GD is an autoimmune disease, which means the body's immune system attacks its own healthy cells. In people with GD, the immune system produces abnormal antibodies, called thyroid-stimulating hormone receptor antibodies (TRAb), that attack the thyroid gland. This causes the thyroid to become too active and produce too much hormone, a condition called hyperthyroidism.\n\nParticipants with GD are often treated with anti-thyroid drugs, or ATDs, which are medicines that help bring thyroid hormone levels back to normal. Felzartamab is designed to target certain immune cells that produce the abnormal TRAb antibodies.\n\nThe main goal of the study is to learn whether felzartamab can help bring thyroid hormone levels back to normal and allow participants to stop taking ATDs. Participants will receive either felzartamab or placebo during the study. A placebo looks like the study drug but contains no real medicine.\n\nThe main question that researchers want to answer is:\n\n• How many participants have normal thyroid levels without receiving any ATD medicine at Week 24?\n\nResearchers will also learn more about the safety of felzartamab and how the body processes the drug.\n\nThe study will be done as follows:\n\n* Participants will be screened to check if they can join the study.\n* This is a double-blind study, which means neither the participants, study doctor, or site staff will know if participants are receiving felzartamab or a placebo.\n* Participants will be placed into 1 of 3 groups. Two groups will receive felzartamab while the other receives placebo.\n* Participants will receive felzartamab or placebo as intravenous (IV) infusions, which are slow injections into a vein using a needle. The Treatment Period will last 20 weeks.\n* During the Treatment Period, the study doctor may gradually lower the dose of the ATD if a participant's thyroid levels become normal.\n* Afterwards, participants will enter a follow-up period which will last 12 weeks.\n* In total, participants will have 22 study visits. Participants will stay in the study for about 9 months (up to 36 weeks).",[137],"Graves' Disease",[139],"Hyperthyroidism","2026-08-20",{"date":142,"type":143},"2026-08-21","ACTUAL",{"date":145,"type":143},"2026-07-30",{"date":147,"type":131},"2028-03-31",{"name":5,"class":6},4]