{"id":"argx-113","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection (including upper respiratory tract infection)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By binding to FcRn, ARGX-113 prevents the recycling and extends the catabolism of IgG antibodies, leading to rapid and sustained reduction in pathogenic autoantibodies. This mechanism is designed to treat autoimmune conditions driven by IgG-mediated pathology, such as myasthenia gravis and other antibody-mediated disorders.","oneSentence":"ARGX-113 is a monoclonal antibody that blocks the neonatal Fc receptor (FcRn) to reduce circulating immunoglobulin levels, particularly IgG antibodies.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:02:23.053Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Generalized myasthenia gravis (gMG)"},{"name":"IgG-mediated autoimmune conditions"}]},"trialDetails":[{"nctId":"NCT04225156","phase":"PHASE3","title":"A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).","status":"COMPLETED","sponsor":"argenx","startDate":"2020-06-02","conditions":"Primary Immune Thrombocytopenia","enrollment":101},{"nctId":"NCT05979441","phase":"PHASE3","title":"A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy","status":"ENROLLING_BY_INVITATION","sponsor":"argenx","startDate":"2023-09-12","conditions":"Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis","enrollment":240},{"nctId":"NCT05681481","phase":"PHASE3","title":"A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid","status":"TERMINATED","sponsor":"argenx","startDate":"2023-03-22","conditions":"Bullous Pemphigoid","enrollment":64},{"nctId":"NCT04812925","phase":"PHASE3","title":"A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia","status":"ACTIVE_NOT_RECRUITING","sponsor":"argenx","startDate":"2021-11-17","conditions":"Primary Immune Thrombocytopenia","enrollment":173},{"nctId":"NCT05918978","phase":"PHASE2","title":"Open Label Extension of 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Have Generalized Muscle Weakness","status":"COMPLETED","sponsor":"argenx","startDate":"2018-08-22","conditions":"Generalized Myasthenia Gravis","enrollment":167},{"nctId":"NCT03334058","phase":"PHASE2","title":"A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus","status":"COMPLETED","sponsor":"argenx","startDate":"2017-10-18","conditions":"Pemphigus Vulgaris, Pemphigus Foliaceus","enrollment":34},{"nctId":"NCT04274452","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)","status":"WITHDRAWN","sponsor":"argenx","startDate":"2020-06-29","conditions":"Primary Immune Thrombocytopenia (ITP)","enrollment":""},{"nctId":"NCT03334084","phase":"PHASE1","title":"A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects","status":"COMPLETED","sponsor":"argenx","startDate":"2017-10-11","conditions":"Bioavailability Study","enrollment":40},{"nctId":"NCT04073589","phase":"PHASE1","title":"Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects","status":"COMPLETED","sponsor":"argenx","startDate":"2019-07-17","conditions":"Healthy 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It is being investigated as a potential treatment for these conditions, including Generalized Myasthenia Gravis, Primary Immune Thrombocytopenia, Pemphigus Vulgaris, and Bioavailability Study.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":7,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}