Etna
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults with Generalized Myasthenia Gravis
IRAS ID
1013247
Contact name
Olivia Maguire
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Clinicaltrials.gov Identifier
Research summary
This study is testing if povetacicept, a new medicine, can safely improve symptoms for people with generalized myasthenia gravis (gMG). gMG is a rare, chronic disease when autoantibodies (part of the immune system) in the blood attack its own body tissues. This leads to difficulty passing the message from nerve to muscle, leading to muscle weakness and fatigability, which can severely impair functional capacity and result in poor quality of life.
In total, about 30 people from 6 different countries will participate in this study, which aims to provide a more effective treatment option for gMG patients, as current treatments don't work for everyone and may lose effectiveness over time.
This study has 2 parts:
Phase 2: A 12 week study where participants don't know if they're receiving the real medicine or placebo. During this part of the study, participants will receive either one of two doses of povetacicept, or placebo. Researchers will study the effect of povetacicept on key markers of gMG and evaluate its safety to determine which dose works best. After completing this phase, participants can choose to continue on the study.Long-Term Extension (LTE): a 96-week extension study where all participants receive povetacicept
Vertex Pharmaceuticals is running the study.
REC name
London - Riverside Research Ethics Committee
REC reference
26/LO/0209
Date of REC Opinion
9 Apr 2026
REC opinion
Further Information Favourable Opinion