Trials / Recruiting
RecruitingNCT07294170
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (estimated)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs). The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration. Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study: * NCT07284420 - ADAPT Forward 1 - 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 (https://www.clinicaltrials.gov/study/NCT07284420)
Conditions
- Myasthenia Gravis
- MG
- gMG
- Generalized Myasthenia Gravis
- Generalized Myasthenia Gravis (gMG)
- AChR-Ab Seropositive Generalized Myasthenia Gravis
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
- 2025-12-19
- Last updated
- 2026-02-18
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07294170. Inclusion in this directory is not an endorsement.