Phase 3
Completed N=167
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
Source: ClinicalTrials.gov NCT03669588 ↗Enrolled (actual)
167
Serious AEs
6.6%
Results posted
Feb 2022
Primary outcomePrimary: Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population — 67.7; 29.7 percentage of patients — p=<0.0001
◆ Published Evidence
Highly cited
670citations · ~134 / year
Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial.
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.
Linked Publications (4)
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Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial.
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Psychometric properties of MG-ADL items and MG-ADL score: An assessment of distributional characteristics, validity and factor structure in two large datasets.
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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).
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population |
67.7; 29.7 | <0.0001 sig |
| SECONDARY Percentage of Quantitative Myasthenia Gravis (QMG) Responders During C1; Analyzed in the AChR-Ab Seropositive Population |
63.1; 14.1 | <0.0001 sig |
| SECONDARY Percentage of MG-ADL Responders During C1; Analyzed in the Overall Population |
67.9; 37.3 | <0.0001 sig |
| SECONDARY Percentage of Time That Patients Had a Clinically Meaningful Improvement (CMI) in MG-ADL Total Score up to and Including Day 126; Analyzed in the AChR-Ab Seropositive Population |
48.714; 26.649 | 0.0001 sig |
| SECONDARY Time From Week 4 to Qualify for Retreatment; Analyzed in the AChR-Ab Seropositive Population |
35.0; 8.0 | 0.2604 |
| SECONDARY Percentage of Early MG-ADL Responders During C1; Analyzed in the AChR-Ab Seropositive Population |
56.9; 25.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- Male or female patients aged ≥ 18 years.
- 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
- Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
- 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.
- MGFA Class I and V patients.
- Patients with worsening muscle weakness secondary to concurrent infections or medications.
- 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.
Data sourced from ClinicalTrials.gov (NCT03669588) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.