A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis
ETNA
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis
2 other identifiers
interventional
30
1 country
9
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2026
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2026
CompletedFirst Posted
Study publicly available on registry
March 30, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 2, 2029
May 18, 2026
March 1, 2026
2.8 years
March 24, 2026
May 15, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percent change in Total Immunoglobulin G (IgG)
Baseline and At Week 12
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Baseline Up to Week 116
Study Arms (2)
Povetacicept
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants will be randomized to receive placebo matched to povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-80 years
- Diagnosis of generalized myasthenia gravis with generalized muscle weakness and fitting MGFA clinical classification II-IV
You may not qualify if:
- History of thymic surgery within 6 months of screening
- History of malignancy within the last 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Neurology Offices
Boca Raton, Florida, 33428, United States
SFM Clinical Reseach, LLC
Boca Raton, Florida, 33487, United States
Homestead Associates in Research
Homestead, Florida, 33033, United States
Quantix Research
Miami, Florida, 33173, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Las Vegas Neurology Center
Las Vegas, Nevada, 89106, United States
Clinical Trials of South Carolina - Neurology
Charleston, South Carolina, 29406, United States
Nerve and Muscle Center of Texas - Neurology
Houston, Texas, 77030, United States
Neurology Care Clinic
Waxahachie, Texas, 75165, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2026
First Posted
March 30, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
March 2, 2029
Study Completion (Estimated)
March 2, 2029
Last Updated
May 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/