A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Povetacicept, Placebo.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis, Generalized. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Poland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis
Overview
The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).
Interventions
- Drug Povetacicept
Solution for Subcutaneous Injection. - Drug Placebo
Solution for Subcutaneous Injection.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Tri Valley Neurology Medical Associates Inc. — Mission Hills
- Neurology Offices — Boca Raton
- SFM Clinical Reseach, LLC — Boca Raton
- Homestead Associates in Research — Homestead
- UF Health Jacksonville Respiratory Therapy (PFT and DLCO) — Jacksonville
- Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - Neurology — Miami
- Quantix Research — Miami
- Hawaii Pacific Neuroscience — Honolulu
- … and 7 more centers
Poland · 7 centers
- MICS Centrum Medyczne Bydgoszcz — Bydgoszcz
- Neurologia Slaska Centrum Medyczne — Katowice
- Clinical Research Center Sp. z o.o., Medic-R Sp. K. — Poznan
- NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy — Poznan
- Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o. o. — Poznan
- Centrum Medyczne Neuroprotect — Warsaw
- ETG Neuroscience — Warsaw
United Kingdom · 3 centers
- University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital — Birmingham
- St. George's University Hospital — London
- Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital — Salford
Australia · 1 center
- Eastern Health - Box Hill Hospital — Box Hill
Identifiers
NCT: NCT07501702 · VX25-AIS-301 · 2025-523950-15-01