Trials / Recruiting
RecruitingNCT07284420
ADAPT Forward 1 - ISA1 - a Study to Evaluate 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
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life. The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis. The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170
Detailed description
Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can then continue to the add-on period (part B) where they will receive both efgartigimod IV and empasiprubart IV. Participants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only. The study duration for each participant is approximately up to 54 weeks.
Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis
- Myasthenia Gravis
- MG
- gMG
- Generalized Myasthenia Gravis
- Generalized Myasthenia Gravis (gMG)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Efgartigimod IV | Intravenous infusion of efgartigimod |
| BIOLOGICAL | Empasiprubart IV | Intravenous infusion of empasiprubart |
Timeline
- Start date
- 2025-12-19
- Primary completion
- 2028-03-07
- Completion
- 2028-03-07
- First posted
- 2025-12-16
- Last updated
- 2026-02-09
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07284420. Inclusion in this directory is not an endorsement.