Clinical trial · Interventional
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness
NCT03669588CI-TRIAL-00056403ADAPTcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Generalized Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARGX-113 | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARGX-113
- interventionNames
- Biological: ARGX-113
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Biological: Placebo
Primary outcomes (1)
- measure
- Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population
- timeFrame
- Baseline up to Day 63 (end of TC1)
- description
- The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered an MG-ADL responder during C1 if there was a reduction of ≥2 points on the MG-ADL total score (compared to baseline of C1 \[C1B\]) for ≥4 consecutive weeks with the first reduction occurring no later than 1 week after the last infusion of IMP in C1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. 2. Male or female patients aged ≥ 18 years. 3. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa and IVb. Other, more specific inclusion criteria are defined in the protocol Exclusion Criteria: 1. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. 2. Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing. 3. MGFA Class I and V patients. 4. Patients with worsening muscle weakness secondary to concurrent infections or medications. 5. Patients with known seropositivity or who test positive for an active viral infection at Screening with: * Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV vaccination) * Hepatitis C Virus (HCV) * Human Immunodeficiency Virus (HIV) Other, more specific exclusion criteria are further defined in the protocol.
References
Publications (4)
- DERIVEDHoward 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. PMID 42234197
- DERIVEDHoffmann 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. PMID 41517964
- DERIVEDJanssen 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. PMID 39068745
- DERIVEDHoward 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. PMID 34146511