An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
Summary
A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.
Timeline
- Start
- 2018-08-22
- Primary completion
- 2020-04-06
- Completion
- 2020-04-06
Outcome
Met primary endpoint
registry NUMBER ARGX-113: 67.7 percentage of patients NUMBER Placebo: 29.7 percentage of patients analysis (superiority test); ARGX-113 vs Placebo; p <0.0001 NCT03669588 ↗
release “ADAPT met its primary endpoint defined as percentage of responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score” argenx.com ↗
release “The ADAPT trial met its primary endpoint demonstrating significantly more acetylcholine receptor-antibody positive (AChR-Ab+) gMG patients were responders” argenx.com ↗
release “The ADAPT trial met its primary endpoint” argenx.com ↗
release “The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders” argenx.com ↗
Publications
- Howard JF Jr, Sacca F, Hoffmann S, Attarian S, De Bleecker JL, Beauchamp J, Brauer E, Kerstens R, Vissing J, Meisel A; ADAPT Study Group. Clinical effectiveness of efgartigimod in a broad population of patients with generalized myasthenia gravis: subgroup analyses from a randomized, double-blind, placebo-controlled, phase 3 trial (ADAPT). J Neurol. 2026 Jun 3;273(6):363. doi: 10.1007/s00415-026-13877-z.
- Hoffmann S, Zhao S, Callewaert F, Schoppe S, Rozsa C, Spillane J. Post Hoc, Sex-Specific Subgroup Analysis of Efgartigimod in Patients With Generalized Myasthenia Gravis From the ADAPT Trial: A Sex and Gender Equity in Research (SAGER) Guidelines Approach. Muscle Nerve. 2026 Apr;73(4):566-574. doi: 10.1002/mus.70135. Epub 2026 Jan 10.
- Janssen MF, Dewilde S, Wolfe GI, Muppidi S, Phillips G. Psychometric properties of MG-ADL items and MG-ADL score: An assessment of distributional characteristics, validity and factor structure in two large datasets. J Neurol Sci. 2024 Aug 15;463:123135. doi: 10.1016/j.jns.2024.123135. Epub 2024 Jul 22.
- Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | 10 mg/kg | Intravenous |