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

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT07501702
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Povetacicept — DRUG
    Solution for Subcutaneous Injection.
  • Placebo — DRUG
    Solution for Subcutaneous Injection.

Study Details

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

Key Dates

Start date
May 13, 2026
Status verified
Jun 2026
Primary completion
Mar 2, 2029
Completion
Mar 2, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Percent change in Total Immunoglobulin G (IgG) [ Time Frame: Baseline and At Week 12 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Neurology OfficesBoca RatonFlorida33428-
SFM Clinical Reseach, LLCBoca RatonFlorida33487-
Homestead Associates in ResearchHomesteadFlorida33033-
UF Health Jacksonville Respiratory Therapy (PFT and DLCO)JacksonvilleFlorida32209-
Quantix ResearchMiamiFlorida33173-
Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - NeurologyMiamiFlorida33144-
Hawaii Pacific NeuroscienceHonoluluHawaii96817-
HSHS Medical Group - St. Elizabeth's HospitalO'FallonIllinois62269-
Las Vegas Neurology CenterLas VegasNevada89106-
Clinical Trials of South Carolina - NeurologyCharlestonSouth Carolina29406-
Nerve and Muscle Center of Texas - NeurologyHoustonTexas77030-
Texas Institute for Neurological DisordersShermanTexas75093-
Neurology Care ClinicWaxahachieTexas75165-

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By research site
Neurology Offices· Boca Raton, FLSFM Clinical Reseach, LLC· Boca Raton, FLHomestead Associates in Research· Homestead, FLUF Health Jacksonville Respiratory Therapy (PFT and DLCO)· Jacksonville, FLQuantix Research· Miami, FLY & L Advance Health Care, Inc D/B/A Elite Clinical Research - Neurology· Miami, FL

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