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Clinical Trial NCT07501702 (ETNA) for Myasthenia Gravis, Generalized is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis (ETNA) Phase 2 30

Not yet recruiting
Clinical Trial NCT07501702 (ETNA) is designed to study Treatment for Myasthenia Gravis, Generalized. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on April 16, 2026 until the study accrues 30 participants. Led by Vertex Pharmaceuticals Incorporated, this study is expected to complete by March 2, 2029. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief 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).
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

Conditions
Myasthenia Gravis, Generalized
Other Study IDs
  • ETNA
  • VX25-AIS-301
  • 2025-523950-15-01 (Other Identifier) (EU Trial (CTIS) Number)
NCT ID Number
NCT07501702
Start Date (Actual)
2026-04-16
Last Update Posted
2026-03-30
Completion Date (Estimated)
2029-03-02
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPovetacicept
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.
Povetacicept
Solution for Subcutaneous Injection.
Placebo ComparatorPlacebo
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.
Povetacicept
Solution for Subcutaneous Injection.
Placebo
Solution for Subcutaneous Injection.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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.

Vertex Pharmaceuticals Incorporated logoVertex Pharmaceuticals Incorporated27 active studies to explore
Study Central Contact
Contact: Medical Information, 617-341-6777, [email protected]
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