A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Neurology Offices
RECRUITING
Boca Raton
SFM Clinical Reseach, LLC
RECRUITING
Boca Raton
Homestead Associates in Research
RECRUITING
Homestead
Quantix Research
RECRUITING
Miami
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Illinois
HSHS Medical Group - St. Elizabeth's Hospital
RECRUITING
O'fallon
Nevada
Las Vegas Neurology Center
RECRUITING
Las Vegas
South Carolina
Clinical Trials of South Carolina - Neurology
RECRUITING
Charleston
Texas
Nerve and Muscle Center of Texas - Neurology
RECRUITING
Houston
Texas Institute for Neurological Disorders
RECRUITING
Sherman
Neurology Care Clinic
RECRUITING
Waxahachie
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2026-05-13
Estimated Completion Date: 2029-03-02
Participants
Target number of participants: 30
Treatments
Experimental: Povetacicept
Participants will be randomized to receive one of the two doses of povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks.
Placebo_comparator: Placebo
Participants will be randomized to receive placebo matched to povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated