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
- Are there results?
- Not yet: the study is under way
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/
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07501702
- Acronym / sponsor ID
- ETNA / VX25-AIS-301
- Conditions
- Myasthenia Gravis, Generalized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 2 Mar 2029 (estimated)
- Study completion
- 2 Mar 2029 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povetacicept | Experimental | Drug: PovetaciceptParticipants 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 | Placebo comparator | Drug: Povetacicept, Drug: PlaceboParticipants will be randomized to receive placebo matched to povetacicept for the initial 12 weeks. Eligible participants can receive povetacicept for an additional 96 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PovetaciceptSolution for Subcutaneous Injection. | Drug | Placebo, Povetacicept |
| PlaceboSolution for Subcutaneous Injection. | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Povetacicept in people with Myasthenia Gravis, Generalized, run by Vertex Pharmaceuticals Incorporated at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Poland, United Kingdom, Turkey (Türkiye), Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (617-341-6777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in Total Immunoglobulin G (IgG) (time frame: Baseline and At Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.