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

NCT07501702 — Phase 2, Recruiting, 30 participants, Vertex Pharmaceuticals Incorporated
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis

RegistryNCT07501702, acronym ETNA
StatusRecruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment30 (Estimated)
SponsorVertex Pharmaceuticals Incorporated (Industry)
ConditionsMyasthenia Gravis, Generalized
InterventionsPovetacicept, Placebo (Drug)
Datesstart 2026-05-13, primary completion 2029-03-02 (estimated), completion 2029-03-02 (estimated), first posted 2026-03-30, last updated 2026-09-11
Locations28 sites in United States, Australia, Poland, Turkey (Türkiye), United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Myasthenia Gravis, Generalized All trials of Povetacicept All trials of Placebo

-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).

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
PovetaciceptExperimentalDrug: 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.
PlaceboPlacebo comparatorDrug: 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.
  • Povetacicept (Drug): Solution for Subcutaneous Injection.
  • Placebo (Drug): Solution for Subcutaneous Injection.

+Outcome measures

Primary outcomes

  • Percent change in Total Immunoglobulin G (IgG) [Baseline and At Week 12]
  • Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [From Baseline Up to Week 116]

+Eligibility

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

* 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:

* 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.

+Locations (28)

FacilityCityCountryStatus
Tri Valley Neurology Medical Associates Inc.Mission Hills, CaliforniaUnited StatesRecruiting
Neurology OfficesBoca Raton, FloridaUnited StatesRecruiting
SFM Clinical Reseach, LLCBoca Raton, FloridaUnited StatesRecruiting
Homestead Associates in ResearchHomestead, FloridaUnited StatesRecruiting
UF Health Jacksonville Respiratory Therapy (PFT and DLCO)Jacksonville, FloridaUnited StatesRecruiting
Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - NeurologyMiami, FloridaUnited StatesRecruiting
Quantix ResearchMiami, FloridaUnited StatesRecruiting
Hawaii Pacific NeuroscienceHonolulu, HawaiiUnited StatesRecruiting
HSHS Medical Group - St. Elizabeth's HospitalO'Fallon, IllinoisUnited StatesRecruiting
Las Vegas Neurology CenterLas Vegas, NevadaUnited StatesRecruiting
Clinical Trials of South Carolina - NeurologyCharleston, South CarolinaUnited StatesRecruiting
Ut Erlanger NeurologyChattanooga, TennesseeUnited StatesRecruiting
Nerve and Muscle Center of Texas - NeurologyHouston, TexasUnited StatesRecruiting
Texas Institute for Neurological DisordersSherman, TexasUnited StatesRecruiting
Neurology Care ClinicWaxahachie, TexasUnited StatesRecruiting
Eastern Health - Box Hill HospitalBox HillAustraliaRecruiting
MICS Centrum Medyczne BydgoszczBydgoszczPolandRecruiting
Neurologia Slaska Centrum MedyczneKatowicePolandRecruiting
Clinical Research Center Sp. z o.o., Medic-R Sp. K.PoznanPolandRecruiting
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska LekarzyPoznanPolandRecruiting
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o. o.PoznanPolandRecruiting
Centrum Medyczne NeuroprotectWarsawPolandRecruiting
ETG NeuroscienceWarsawPolandRecruiting
Istanbul University Medical FacultyFatihTurkey (Türkiye)Recruiting
Kocaeli University Medical FacultyKocaeliTurkey (Türkiye)Recruiting
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth HospitalBirminghamUnited KingdomRecruiting
St. George's University HospitalLondonUnited KingdomRecruiting
Northern Care Alliance NHS Foundation Trust - Salford Royal HospitalSalfordUnited KingdomRecruiting

+Funding

NIH grants: 2025