ARGX-113
Sponsors
Argenx, argenx
Conditions
AChR-Ab Seropositive Generalized Myasthenia GravisAcetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia GravisActive Idiopathic Inflammatory Myopathy (IIM)Bioavailability StudyBullous PemphigoidBullous Pemphigoid (BP)Chronic Idiopathic thrombocytopenic purpuraChronic Inflammatory Demyelinating Polyneuropathy
Phase 1
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
CompletedNCT03334084
Start: 2017-10-11End: 2018-09-19Updated: 2020-08-31
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
CompletedNCT03457649
Start: 2015-09-09End: 2017-02-21Updated: 2024-05-23
Phase 2
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
CompletedNCT02965573
Start: 2016-12-30End: 2017-10-20Updated: 2024-08-28
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP
CompletedNCT03102593
Start: 2017-03-13End: 2019-04-09Updated: 2023-07-25
A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus
CompletedNCT03334058
Start: 2017-10-18End: 2020-10-28Updated: 2020-12-14
ARGX-113-2211: Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients with primary Sjögren’s Syndrome (pSS) who complete qualifying efgartigimod pSS studies
CompletedCTIS2023-503915-14-00
Start: 2023-11-15End: 2025-02-03Target: 27Updated: 2025-01-13
Open-label Extension of the ARGX-113-1802 Trial to Investigate the Longterm
Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients
With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
RecruitingCTIS2023-507885-21-00
Start: 2020-08-18Target: 88Updated: 2025-10-31
A Long-term, Single-Arm, Open-label, Multicenter Trial to Evaluate Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
RecruitingCTIS2023-507379-23-00
Start: 2022-08-18Target: 19Updated: 2025-12-03
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
CompletedCTIS2023-508645-40-00
Start: 2022-05-10End: 2024-09-13Target: 90Updated: 2024-08-22
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Active, not recruitingCTIS2024-512785-33-00
Start: 2023-03-01Target: 186Updated: 2025-10-16
ARGX-113-2409: A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo- Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants from 12 Years to Less Than 18 Years of Age with Chronic ITP
RecruitingCTIS2025-521055-23-00
Start: 2025-10-07Target: 16Updated: 2026-01-16
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
Phase 3
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
CompletedNCT03669588
Start: 2018-08-22End: 2020-04-06Updated: 2022-02-08
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
CompletedNCT03770403
Start: 2019-03-01End: 2022-06-30Updated: 2023-07-14
A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
RecruitingCTIS2022-502851-79-00
Start: 2023-09-20Target: 80Updated: 2025-09-24
ARGX-113-1803: A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia
CompletedCTIS2024-511504-17-00
Start: 2020-12-15End: 2025-12-12Target: 6Updated: 2026-01-12
A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Active, not recruitingCTIS2024-513147-90-00
Start: 2022-04-26Target: 20Updated: 2026-01-12
A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
Active, not recruitingCTIS2024-511796-15-00
Start: 2024-10-16Target: 167Updated: 2025-10-07
An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
CompletedCTIS2024-515832-59-00
Start: 2022-05-03End: 2025-01-13Target: 43Updated: 2025-01-23
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
RecruitingCTIS2024-515451-38-00
Start: 2025-02-27Target: 52Updated: 2026-01-23