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NCT Number: NCT07501702

A Phase 2 Study to Evaluate 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).

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Key information

Conditions

Myasthenia Gravis, Generalized Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eastern Health - Box Hill Hospital, Box Hill, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povetacicept

Drug

Solution for Subcutaneous Injection.

Placebo

Drug

Solution for Subcutaneous Injection.

Primary outcomes

  1. Percent change in Total Immunoglobulin G (IgG)

    Time frame: Baseline and At Week 12

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Acronym: ETNA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 30, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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