Myasthenia Gravis, GeneralizedPhase 2ETNANCT07501702
A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis
A Phase 2 study testing Povetacicept in people with Myasthenia Gravis, Generalized, run by Vertex Pharmaceuticals Incorporated at 28 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, Generalized
- What is being tested?
- Povetacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 13 May 2026to 2 Mar 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
28 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 5 countries
United States15 sites, 15 recruiting
- Recruiting
Neurology Offices
Boca Raton, Florida, 33428
- Recruiting
SFM Clinical Reseach, LLC
Boca Raton, Florida, 33487
- Recruiting
Clinical Trials of South Carolina - Neurology
Charleston, South Carolina, 29406
- Recruiting
Ut Erlanger Neurology
Chattanooga, Tennessee, 37403
- Recruiting
Homestead Associates in Research
Homestead, Florida, 33033
- Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
- Recruiting
Nerve and Muscle Center of Texas - Neurology
Houston, Texas, 77030
- Recruiting
UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
Jacksonville, Florida, 32209
- Recruiting
Las Vegas Neurology Center
Las Vegas, Nevada, 89106
- Recruiting
Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - Neurology
Miami, Florida, 33144
- Recruiting
Quantix Research
Miami, Florida, 33173
- Recruiting
Tri Valley Neurology Medical Associates Inc.
Mission Hills, California, 91345
- Recruiting
HSHS Medical Group - St. Elizabeth's Hospital
O'Fallon, Illinois, 62269
- Recruiting
Texas Institute for Neurological Disorders
Sherman, Texas, 75093
- Recruiting
Neurology Care Clinic
Waxahachie, Texas, 75165
Poland7 sites, 7 recruiting
- Recruiting
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz
- Recruiting
Neurologia Slaska Centrum Medyczne
Katowice
- Recruiting
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan
- Recruiting
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy
Poznan
- Recruiting
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o. o.
Poznan
- Recruiting
Centrum Medyczne Neuroprotect
Warsaw
- Recruiting
ETG Neuroscience
Warsaw
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham
- Recruiting
St. George's University Hospital
London
- Recruiting
Northern Care Alliance NHS Foundation Trust - Salford Royal Hospital
Salford
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul University Medical Faculty
Fatih
- Recruiting
Kocaeli University Medical Faculty
Kocaeli
Australia1 site, 1 recruiting
- Recruiting
Eastern Health - Box Hill Hospital
Box Hill
About this study
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
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
- Being tested
- Povetacicept, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovetaciceptDrug
Solution for Subcutaneous Injection.
PlaceboDrug
Solution for Subcutaneous Injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Povetacicept; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Total Immunoglobulin G (IgG)
Measured: Baseline and At Week 12
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Baseline Up to Week 116
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start13 May 2026
- Primary completion2 Mar 2029 (estimated)
- Study completion2 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis, GeneralizedStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501702
- Sponsor's protocol ID
- VX25-AIS-301
- Other IDs
- 2025-523950-15-01, 2025
- Acronym
- ETNA
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/