NCT07501702

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
31mo left

Started May 2026

Typical duration for phase_2

Geographic Reach
4 countries

24 active sites

Status
recruiting

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

Study Progress8%
May 2026Mar 2029

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 13, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2029

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

March 24, 2026

Last Update Submit

July 20, 2026

Conditions

Myasthenia Gravis, Generalized

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

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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: PovetaciceptDrug: Placebo

Interventions

PovetaciceptDRUG

Solution for Subcutaneous Injection.

PlaceboPovetacicept
PlaceboDRUG

Solution for Subcutaneous Injection.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 (24)

Neurology Offices

Boca Raton, Florida, 33428, United States

RECRUITING

SFM Clinical Reseach, LLC

Boca Raton, Florida, 33487, United States

RECRUITING

Homestead Associates in Research

Homestead, Florida, 33033, United States

RECRUITING

UF Health Jacksonville Respiratory Therapy (PFT and DLCO)

Jacksonville, Florida, 32209, United States

RECRUITING

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

Miami, Florida, 33144, United States

RECRUITING

Quantix Research

Miami, Florida, 33173, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

HSHS Medical Group - St. Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

RECRUITING

Las Vegas Neurology Center

Las Vegas, Nevada, 89106, United States

RECRUITING

Clinical Trials of South Carolina - Neurology

Charleston, South Carolina, 29406, United States

RECRUITING

Ut Erlanger Neurology

Chattanooga, Tennessee, 37403, United States

RECRUITING

Nerve and Muscle Center of Texas - Neurology

Houston, Texas, 77030, United States

RECRUITING

Texas Institute for Neurological Disorders

Sherman, Texas, 75093, United States

RECRUITING

Neurology Care Clinic

Waxahachie, Texas, 75165, United States

RECRUITING

Eastern Health - Box Hill Hospital

Box Hill, Australia

RECRUITING

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

RECRUITING

Neurologia Slaska Centrum Medyczne

Katowice, Poland

RECRUITING

Clinical Research Center Sp. z o.o., Medic-R Sp. K.

Poznan, Poland

RECRUITING

NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy

Poznan, Poland

RECRUITING

Centrum Medyczne Neuroprotect

Warsaw, Poland

RECRUITING

ETG Neuroscience

Warsaw, Poland

RECRUITING

University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, United Kingdom

RECRUITING

St. George's University Hospital

London, United Kingdom

RECRUITING

Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital

Salford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Medical Information

CONTACT

617-341-6777medicalinfo@vrtx.com

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 13, 2026

Primary Completion (Estimated)

March 2, 2029

Study Completion (Estimated)

March 2, 2029

Last Updated

July 21, 2026

Record last verified: 2026-07

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/

Locations

AU(1)PL(6)US(14)GB(3)