[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459642":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":203,"collaborators":30,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":30,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":30,"studyType":218,"phases":219,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nipocalimab","EXPERIMENTAL","Participants age 2 to less than (\\\u003C) 18 years of age (globally) and 8 to \\\u003C18 years of age (for US sites only) will be divided into 2 cohorts as per their age-adolescents 12 to \\\u003C18 years and children 2 to \\\u003C12 years and will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).",[13],"Drug: Nipocalimab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Nipocalimab will be administered as an IV infusion.",[9],[20],"M281\u002FJNJ-80202135",[22],{"name":23,"affiliation":5,"role":24},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Study Contact","CONTACT","844-434-4210",null,"Participate-In-This-Study1@its.jnj.com",[33,47,57,66,75,85,95,106,116,126,135,145,151,160,169,173,177,181,192],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":30},"Phoenix Children's Hospital","RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-112.07404,33.44838,{"lat":45,"lon":44},{"facility":48,"status":35,"city":49,"state":50,"zip":51,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":30},"Childrens Hospital Los Angeles","Los Angeles","California","90027",{"type":42,"coordinates":53},[54,55],-118.24368,34.05223,{"lat":55,"lon":54},{"facility":58,"status":35,"city":59,"state":50,"zip":60,"country":39,"countryCode":40,"cosmosGeoPoint":61,"geoPoint":65,"contacts":30},"Lucile Packard Children's Hospital Stanford","Palo Alto","94304",{"type":42,"coordinates":62},[63,64],-122.14302,37.44188,{"lat":64,"lon":63},{"facility":67,"status":35,"city":68,"state":50,"zip":69,"country":39,"countryCode":40,"cosmosGeoPoint":70,"geoPoint":74,"contacts":30},"UCSF Benioff Children's Hospital","San Francisco","94158",{"type":42,"coordinates":71},[72,73],-122.41942,37.77493,{"lat":73,"lon":72},{"facility":76,"status":35,"city":77,"state":78,"zip":79,"country":39,"countryCode":40,"cosmosGeoPoint":80,"geoPoint":84,"contacts":30},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":42,"coordinates":81},[82,83],-104.83192,39.72943,{"lat":83,"lon":82},{"facility":86,"status":35,"city":87,"state":88,"zip":89,"country":39,"countryCode":40,"cosmosGeoPoint":90,"geoPoint":94,"contacts":30},"University of South Florida Morsani Center for Advanced Healthcare","Tampa","Florida","33613",{"type":42,"coordinates":91},[92,93],-82.45843,27.94752,{"lat":93,"lon":92},{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":39,"countryCode":40,"cosmosGeoPoint":101,"geoPoint":105,"contacts":30},"University of Kansas Medical Center","COMPLETED","Lawrence","Kansas","66045",{"type":42,"coordinates":102},[103,104],-95.23525,38.97167,{"lat":104,"lon":103},{"facility":107,"status":35,"city":108,"state":109,"zip":110,"country":39,"countryCode":40,"cosmosGeoPoint":111,"geoPoint":115,"contacts":30},"C.S. Mott Children's Hospital","Ann Arbor","Michigan","48109",{"type":42,"coordinates":112},[113,114],-83.74088,42.27756,{"lat":114,"lon":113},{"facility":117,"status":35,"city":118,"state":119,"zip":120,"country":39,"countryCode":40,"cosmosGeoPoint":121,"geoPoint":125,"contacts":30},"Penn State Milton S Hershey Medical Ctr","Hershey","Pennsylvania","17033",{"type":42,"coordinates":122},[123,124],-76.65025,40.28592,{"lat":124,"lon":123},{"facility":127,"status":35,"city":128,"state":119,"zip":129,"country":39,"countryCode":40,"cosmosGeoPoint":130,"geoPoint":134,"contacts":30},"Childrens Hospital Of Philadelphia","Philadelphia","19106",{"type":42,"coordinates":131},[132,133],-75.16362,39.95238,{"lat":133,"lon":132},{"facility":136,"status":137,"city":138,"state":119,"zip":139,"country":39,"countryCode":40,"cosmosGeoPoint":140,"geoPoint":144,"contacts":30},"University of Pittsburgh Medical Center","TERMINATED","Pittsburgh","15224",{"type":42,"coordinates":141},[142,143],-79.99589,40.44062,{"lat":143,"lon":142},{"facility":146,"status":35,"city":147,"state":30,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Nagano Children's Hospital","Azumino-shi","399-8288","Japan","JP",{"facility":152,"status":97,"city":153,"state":30,"zip":154,"country":149,"countryCode":150,"cosmosGeoPoint":155,"geoPoint":159,"contacts":30},"Chiba University Hospital","Chiba","260 8677",{"type":42,"coordinates":156},[157,158],140.11667,35.6,{"lat":158,"lon":157},{"facility":161,"status":35,"city":162,"state":30,"zip":163,"country":149,"countryCode":150,"cosmosGeoPoint":164,"geoPoint":168,"contacts":30},"University of Miyazaki Hospital","Miyazaki","889-1692",{"type":42,"coordinates":165},[166,167],131.41667,31.91667,{"lat":167,"lon":166},{"facility":170,"status":35,"city":171,"state":30,"zip":172,"country":149,"countryCode":150,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Hyogo College of Medicine Hospital","Nishinomiya-Shi","663-8501",{"facility":174,"status":35,"city":175,"state":30,"zip":176,"country":149,"countryCode":150,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Saitama Prefecture Children's Medical Center","Saitama Shi","330-8777",{"facility":178,"status":35,"city":179,"state":30,"zip":180,"country":149,"countryCode":150,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Tokyo Women's Medical University Hospital","Shinjuku-ku","162-8666",{"facility":182,"status":35,"city":183,"state":30,"zip":184,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":191,"contacts":30},"Leiden University Medical Center","Leiden","2333 ZA","Netherlands","NL",{"type":42,"coordinates":188},[189,190],4.49306,52.15833,{"lat":190,"lon":189},{"facility":193,"status":35,"city":194,"state":30,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":30},"Uniwersyteckie Centrum Kliniczne","Gdansk","80 211","Poland","PL",{"type":42,"coordinates":199},[200,201],18.64912,54.35227,{"lat":201,"lon":200},{"type":204,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100459642","phase-2-a-study-of-nipocalimab-in-children-aged-2-to-less-than-18-years-with-generalized-myasthenia-gravis-100459642",false,"NCT05265273","A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis","An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis","Key Inclusion Criteria:\n\n* Age: For US sites only: 8 to \\\u003C 18 years\n* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa\u002Fb, IIIa\u002Fb, or IVa\u002Fb at screening\n* Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening\n* A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study\n* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol\n* Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance\n* A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \\[beta-hCG\\]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention\n\nKey Exclusion Criteria:\n\n* Has a history of severe and\u002For uncontrolled hepatic (example, viral\u002Falcoholic\u002F autoimmune hepatitis\u002F cirrhosis\u002F and\u002For metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), risk factors for thrombosis events (example, a history of venous thromboembolism \\[VTE\\] or antiphospholipid syndrome, or a personal or family history of heritable coagulation disorder such as factor V leiden, protein S or protein C deficiency, atrial fibrillation\u002Fflutter, major orthopedic surgery or significant trauma that may increase the risk of VTE, is expected to be immobilized for prolonged periods of time), or has clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and\u002F or might jeopardize the safety of the participant or the validity of the study results\n* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his\u002Fher generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study\n* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)\n* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening","ALL","2 Years","17 Years",{"count":216,"type":217},12,"ESTIMATED","INTERVENTIONAL",[220,221],"PHASE2","PHASE3","The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\\\u003C) 18 years of age (globally) and 8 to \\\u003C18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.",[224],"Myasthenia Gravis",[226],"Pediatric","2026-03-12",{"date":229,"type":230},"2026-03-13","ACTUAL",{"date":232,"type":230},"2022-07-20",{"date":234,"type":217},"2029-07-02",{"name":5,"class":6},19]