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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Neurology Offices
Boca Raton, Florida 33428

SFM Clinical Reseach, LLC
Boca Raton, Florida 33487

Homestead Associates in Research
Homestead, Florida 33033

UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
Jacksonville, Florida 32209

Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - Neurology
Miami, Florida 33144

Quantix Research
Miami, Florida 33173

Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817

HSHS Medical Group - St. Elizabeth's Hospital
O'Fallon, Illinois 62269

Las Vegas Neurology Center
Las Vegas, Nevada 89106

Clinical Trials of South Carolina - Neurology
Charleston, South Carolina 29406

Nerve and Muscle Center of Texas - Neurology
Houston, Texas 77030

Texas Institute for Neurological Disorders
Sherman, Texas 75093

Neurology Care Clinic
Waxahachie, Texas 75165

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.