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A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

NCT04650854•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Study participant must meet one of the following:
•1. completed MG0003 \[NCT03971422\]
•2. required rescue therapy during the Observation Period in MG0003 or
•3. completed at least 6 visits in MG0004 \[NCT04124965\]
•Body weight ≥35 kg at Baseline (Day 1)
•Study participants may be male or female

Exclusion Criteria

•Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
•Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
•Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study
•Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab
•Study participant with severe (defined as Grade 3 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis

Locations (69)

Mg0007 50092

Orange, California, United States

Mg0007 50099

San Francisco, California, United States

Mg0007 50122

Miami, Florida, United States

Mg0007 50120

Miami, Florida, United States

Mg0007 50073

Tampa, Florida, United States

Mg0007 50075

Augusta, Georgia, United States

Mg0007 50323

Honolulu, Hawaii, United States

Mg0007 50114

Indianapolis, Indiana, United States

Mg0007 50121

Lexington, Kentucky, United States

Mg0007 50077

New York, New York, United States

Key Dates

Start Date

February 3, 2021

Primary Completion Date

January 25, 2024

Completion Date

January 25, 2024

Last Updated

April 18, 2025

Enrollment

165

ACTUAL participants

Conditions

Generalized Myasthenia Gravis

Interventions

Rozanolixizumab

DRUG

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

NCT07247279

Rare DiseasesGeneralized Myasthenia Gravis (gMG)

View study

RECRUITINGPHASE2/PHASE3

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

NCT06055959

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: April 18, 2025Data 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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A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

Inclusion Criteria

Exclusion Criteria

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

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

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

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis

Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis