Phase 3
N=167
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
Generalized Myasthenia Gravis
Bottom Line
View on ClinicalTrials.gov: NCT03669588 ↗Enrolled (actual)
167
Serious AEs
6.6%
Results posted
Feb 2022
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ARGX-113 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- argenx
- Primary completion
- Apr 2020
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 | — |
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.
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). 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.