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Phase 2
Age: 18Years - 80Years
All Genders
ID07501702

Phase 2 Study of Povetacicept for Adults Aged 18 to 80 With Generalized Myasthenia Gravis Randomized, Double-Blind, Placebo-Controlled with Long-term Extension

Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-08-03

30

Participants Needed

26

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the pharmacodynamic effect, safety, and tolerability of Povetacicept in adults with generalized myasthenia gravis gMG. This phase 2 study focuses on participants aged 18 to 80 years who have generalized muscle weakness and fall within the MGFA clinical classification II-IV. The study aims to better understand how Povetacicept affects immunoglobulin levels and the safety profile in this population. Participants will be randomly assigned to receive one of two doses of Povetacicept or a placebo via subcutaneous injection for the initial 12 weeks. Those who are eligible may continue treatment with Povetacicept for an additional 96 weeks in a long-term extension phase. This study uses a double-blind, placebo-controlled design to evaluate the treatment over a total period of up to 108 weeks. During the study, participants will undergo evaluations of immunoglobulin G levels at baseline and week 12. Safety and tolerability will be monitored throughout the entire treatment period by tracking adverse and serious adverse events. The study includes regular assessments to measure outcomes and monitor participant health, with the goal of completing by March 2029.

CONDITIONS

Brief Title

A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis

Research Team

M

Medical Information

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