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

Phase 2RecruitingNCT07501702

Vertex Pharmaceuticals Incorporated30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Myasthenia Gravis, Generalized

Interventions

PovetaciceptDRUG

Solution for Subcutaneous Injection.

PlaceboDRUG

Solution for Subcutaneous Injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (3)

Quantix Research

Miami, Florida, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

RECRUITING

Clinical Trials of South Carolina - Neurology

Charleston, South Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Medical Information

CONTACT

617-341-6777 medicalinfo@vrtx.com

Data from ClinicalTrials.gov

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