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Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis

NCT03315130•Ra Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of gMG \[Myasthenia Gravis Foundation of America (MGFA) Class II-IVa\] at Screening
•Positive serology for acetylcholine receptor (AChR) autoantibodies
•QMG score ≥ 12 at Screening and Randomization
•No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
•No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period

Exclusion Criteria

•Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12 week Treatment Period
•History of meningococcal disease
•Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization

Locations (30)

Diagnostic and Medical Clinic - Mobile

Mobile, Alabama, United States

The Research Center of Southern California

Carlsbad, California, United States

UCLA Medical Center

Los Angeles, California, United States

University of California Irvine Health ALS and Neuromuscular Center

Orange, California, United States

Yale University

New Haven, Connecticut, United States

George Washington University

Washington D.C., District of Columbia, United States

University of Florida

Jacksonville, Florida, United States

University of South Florida

Tampa, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Key Dates

Start Date

October 11, 2017

Primary Completion Date

December 10, 2018

Completion Date

November 19, 2020

Last Updated

July 27, 2022

Enrollment

ACTUAL participants

Conditions

Generalized Myasthenia Gravis

Interventions

zilucoplan (RA101495)

DRUG

Placebo

DRUG

Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

NCT07247279

Rare DiseasesGeneralized Myasthenia Gravis (gMG)

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RECRUITINGPHASE2/PHASE3

A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

NCT06149559

Generalized Myasthenia Gravis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

Inclusion Criteria

Exclusion Criteria

Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia

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