Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-05-18
30
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacodynamic effects, safety, and tolerability of Povetacicept in adults with generalized myasthenia gravis (gMG), a condition characterized by generalized muscle weakness. This Phase 2 study aims to understand how Povetacicept impacts the immune system and its potential in managing gMG symptoms. Participants are randomly assigned to receive one of two doses of Povetacicept or a matching placebo for the first 12 weeks. Those who qualify may continue receiving Povetacicept for an additional 96 weeks in a long-term extension phase. The drug is given as a solution through subcutaneous injection. During the study, participants will be monitored for changes in their immunoglobulin G (IgG) levels from baseline to week 12 and observed for any adverse events throughout the entire period of up to 116 weeks. The study involves regular safety and tolerability assessments to ensure participant well-being during treatment and long-term follow-up.
CONDITIONS
Brief Title
A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosis of generalized myasthenia gravis with generalized muscle weakness
- MGFA clinical classification II-IV
- Additional inclusion criteria defined in the protocol
You will not qualify if you...
- History of thymic surgery within 6 months of screening
- History of malignancy within the last 5 years
- Additional exclusion criteria defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive povetacicept or placebo subcutaneous injections during the initial treatment period.
Visits during the initial 12-week treatment period
Duration - Up to 96 weeks
Eligible participants continue to receive povetacicept subcutaneous injections during the long-term extension period.
Visits during the long-term extension period
Trial Site Locations
Total: 9 locations
1
Neurology Offices
Boca Raton, Florida, United States, 33428
Actively Recruiting
2
SFM Clinical Reseach, LLC
Boca Raton, Florida, United States, 33487
Actively Recruiting
3
Homestead Associates in Research
Homestead, Florida, United States, 33033
Actively Recruiting
4
Quantix Research
Miami, Florida, United States, 33173
Actively Recruiting
5
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817
Actively Recruiting
6
Las Vegas Neurology Center
Las Vegas, Nevada, United States, 89106
Actively Recruiting
7
Clinical Trials of South Carolina - Neurology
Charleston, South Carolina, United States, 29406
Actively Recruiting
8
Nerve and Muscle Center of Texas - Neurology
Houston, Texas, United States, 77030
Actively Recruiting
9
Neurology Care Clinic
Waxahachie, Texas, United States, 75165
Actively Recruiting
Research Team
M
Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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