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

May 15, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Recruiting
        • Neurology Offices
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • SFM Clinical Reseach, LLC
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Homestead Associates in Research
      • Miami, Florida, United States, 33173
        • Recruiting
        • Quantix Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Las Vegas Neurology Center
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Clinical Trials of South Carolina - Neurology
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Nerve and Muscle Center of Texas - Neurology
      • Waxahachie, Texas, United States, 75165
        • Recruiting
        • Neurology Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Povetacicept
Solution for Subcutaneous Injection.
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.
Drug: Povetacicept
Solution for Subcutaneous Injection.
Drug: Placebo
Solution for Subcutaneous Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in Total Immunoglobulin G (IgG)
Time Frame: Baseline and At Week 12
Baseline and At Week 12
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Baseline Up to Week 116
From Baseline Up to Week 116

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

March 2, 2029

Study Completion (Estimated)

March 2, 2029

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX25-AIS-301
  • 2025-523950-15-01 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myasthenia Gravis, Generalized

Clinical Trials on Povetacicept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe