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40736","London",{"type":44,"coordinates":117},[118,119],-0.12574,51.50853,{"lat":119,"lon":118},{"type":122,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100520391","phase-2-a-study-to-evaluate-subcutaneous-zilucoplan-in-pediatric-participants-with-generalized-myasthenia-gravis-100520391",false,"NCT06055959","A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis","A Multicenter Open-Label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis","ziMyG","Inclusion Criteria:\n\nUnited States of America (USA) specific inclusion criterion:\n\n\\- Participant must be 12 to \\\u003C18 years of age at the time of signing the Informed consent\u002Fassent according to local regulation\n\nRest of world (ROW) specific inclusion criterion:\n\n\\- Participant must be 2 to \\\u003C18 years of age at the time of signing the Informed consent\u002Fassent according to local regulation\n\nGlobal inclusion criteria:\n\n* Participant has a diagnosis of generalized myasthenia gravis (gMG) confirmed by a prior positive serologic test result to acetylcholine receptor (AChR) prior to Screening\n* Participant meets the criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening\n* Participants with gMG, including:\n* An MG-activities of daily living (MG-ADL) total score of 6 or more in adolescents from 12 years to \\\u003C18 years of age at Screening\n* Documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2 years to \\\u003C12 years of age at Screening (does not apply to US)\n* Documented vaccination against meningococcal infections within 3 years prior to study start. If not fully vaccinated, participants must receive appropriate prophylactic antibiotic treatment until at least 2 weeks after the initial dose of vaccine(s)\n\nExclusion Criteria:\n\n* Participant has known positive serology for muscle-specific kinase\n* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study\n* Participant has had a thymectomy within 6 months prior to Baseline\n* Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator\n* Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline","ALL","12 Years","17 Years",{"count":135,"type":136},8,"ESTIMATED","INTERVENTIONAL",[139,140],"PHASE2","PHASE3","The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (ZLP) in pediatric study participants with generalized myasthenia gravis (gMG).",[143],"Generalized Myasthenia Gravis",[21,145,146,147,148,149],"gMG","generalized myasthenia gravis","zilucoplan","pediatric","MG0014","2026-05-07",{"date":152,"type":153},"2026-05-08","ACTUAL",{"date":155,"type":153},"2024-10-16",{"date":157,"type":136},"2026-12-25",{"name":159,"class":6},"UCB Biopharma SRL",9]