Recruiting
Phase 2

Povetacicept

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07501702

Conditions

Myasthenia Gravis, Generalized

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Povetacicept

Placebo

Study Details

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).

Conditions

Myasthenia Gravis, Generalized

Study ID

NCT07501702

Start date

May 13, 2026

Status verified date

Sep, 2026

Completion date

Mar 2, 2029

Anticipated

Primary completion date

Mar 2, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Age greater than or equal to (>=) 18 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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Povetacicept

Solution for Subcutaneous Injection.

Placebo

Solution for Subcutaneous Injection.

Primary outcome measure

  • Percent change in Total Immunoglobulin G (IgG) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

Tri Valley Neurology Medical Associates Inc.

Recruiting

Mission Hills, California, United States, 91345

Neurology Offices

Recruiting

Boca Raton, Florida, United States, 33428

SFM Clinical Reseach, LLC

Recruiting

Boca Raton, Florida, United States, 33487

Homestead Associates in Research

Recruiting

Homestead, Florida, United States, 33033

UF Health Jacksonville Respiratory Therapy (PFT and DLCO)

Recruiting

Jacksonville, Florida, United States, 32209

Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - Neurology

Recruiting

Miami, Florida, United States, 33144

Quantix Research

Recruiting

Miami, Florida, United States, 33173

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

HSHS Medical Group - St. Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Las Vegas Neurology Center

Recruiting

Las Vegas, Nevada, United States, 89106

Clinical Trials of South Carolina - Neurology

Recruiting

Charleston, South Carolina, United States, 29406

Ut Erlanger Neurology

Recruiting

Chattanooga, Tennessee, United States, 37403

Nerve and Muscle Center of Texas - Neurology

Recruiting

Houston, Texas, United States, 77030

Texas Institute for Neurological Disorders

Recruiting

Sherman, Texas, United States, 75093

Neurology Care Clinic

Recruiting

Waxahachie, Texas, United States, 75165

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-09-04.