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
NCT07284420 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-04-23
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
Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis
- Myasthenia Gravis
- MG
- gMG
- Generalized Myasthenia Gravis
- Generalized Myasthenia Gravis (gMG)
Interventions
- BIOLOGICAL
-
Efgartigimod IV
Intravenous infusion of efgartigimod
- BIOLOGICAL
-
Empasiprubart IV
Intravenous infusion of empasiprubart
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-19
- Primary Completion
- 2028-03-07
- Completion
- 2028-03-07
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Poland
- Spain
Study Locations
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