Povetacicept for adults with generalized myasthenia gravis
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis
This study will try povetacicept versus placebo to see if it is safe, tolerated, and changes disease activity in adults aged 18–80 with generalized myasthenia gravis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 6 sites (Boca Raton, Florida and 5 other locations) |
| Trial ID | NCT07501702 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives eligible adults with generalized myasthenia gravis povetacicept or placebo to measure pharmacodynamic effects as well as safety and tolerability. Participants must have generalized muscle weakness corresponding to MGFA class II–IV and meet other protocol criteria. Important exclusions include recent thymic surgery (within 6 months) and a history of malignancy within the last 5 years. Study visits are conducted at neurology research sites in Florida and include clinical and laboratory monitoring to track drug effects and adverse events.
Who should consider this trial
Good fit: Adults 18–80 with generalized myasthenia gravis classified as MGFA II–IV who meet the protocol's inclusion criteria and can attend site visits are the intended participants.
Not a fit: People with ocular-only myasthenia gravis, recent thymic surgery within 6 months, recent malignancy in the past 5 years, or other protocol exclusions may not benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, povetacicept could become a new treatment option that improves muscle strength or disease control while being well tolerated.
How similar studies have performed: Therapies targeting B-cell and related immune pathways have shown benefit in some autoimmune diseases and certain myasthenia gravis populations, but povetacicept itself is still in early clinical testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Age 18-80 years * Diagnosis of generalized myasthenia gravis with generalized muscle weakness and fitting MGFA clinical classification II-IV * Additional inclusion criteria are defined in the protocol Key Exclusion Criteria: * History of thymic surgery within 6 months of screening * History of malignancy within the last 5 years * Additional exclusion criteria are defined in the protocol Other protocol defined Inclusion/Exclusion criteria will apply.
Where this trial is running
Boca Raton, Florida and 5 other locations
- Neurology Offices — Boca Raton, Florida, United States (Recruiting)
- Homestead Associates in Research — Homestead, Florida, United States (Recruiting)
- Quantix Research — Miami, Florida, United States (Recruiting)
- Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (Recruiting)
- Las Vegas Neurology Center — Las Vegas, Nevada, United States (Recruiting)
- Clinical Trials of South Carolina - Neurology — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.