ARGX-117
Sponsors
Argenx, argenx
Conditions
AChR-Ab Seropositive Generalized Myasthenia GravisChronic inflammatory demyelinating polyneuropathy (CIDP)Delayed Graft FunctionDelayed graft functionDermatomyositisHealthy VolunteersMGMultifocal Motor Neuropathy
Phase 1
Phase 2
A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
CompletedNCT05225675
Start: 2022-03-31End: 2024-06-04Updated: 2026-05-08
A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
Active, not recruitingNCT05405361
Start: 2023-01-18End: 2029-09-30Updated: 2026-03-11
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Active, not recruitingNCT05907096
Start: 2024-02-17End: 2026-07-31Updated: 2026-03-18
A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function (Varvara)
Active, not recruitingCTIS2022-503091-89-00
Start: 2024-02-15Target: 87Updated: 2025-06-06
A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
Active, not recruitingCTIS2023-507052-69-00
Start: 2023-03-29Target: 34Updated: 2025-07-07
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With Dermatomyositis
CompletedCTIS2023-508337-14-00
Start: 2025-03-18End: 2025-09-04Target: 19Updated: 2025-06-05
Master Protocol Full Title: A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis.
ISA 1 Full Title: An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod.
Not yet recruitingCTIS2025-522492-28-00
Target: 3Updated: 2026-02-18
Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis.
ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
Not yet recruitingCTIS2025-522939-33-00
Target: 10Updated: 2026-07-10
Phase 3
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy.
RecruitingCTIS2024-516473-72-00
Start: 2025-07-31Target: 134Updated: 2026-01-21
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingCTIS2024-520097-36-00
Start: 2026-01-07Target: 108Updated: 2025-12-09
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Not yet recruitingCTIS2025-520805-10-00
Target: 16Updated: 2026-02-11