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

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Myasthenia Gravis, Generalized

Treatments: Drug: Placebo; Drug: Povetacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT07501702

VX25-AIS-301

2025-523950-15-01 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Povetacicept

Experimental group

Description:

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.

Treatment:

Drug: Povetacicept

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Povetacicept

Drug: Placebo