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Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis | Clinical Trials | Clareo Health

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Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis

A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis

NCT03052751•UCB Biopharma S.P.R.L.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the clinical efficacy of UCB7665 as a chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations
•Subject would currently be considered for treatment with immunological therapy (immunoglobulin/plasma exchange (IVIG/PLEX)) by the investigator
•Subject has a well-documented record of autoantibodies against anti-acetylcholine receptor (Anti-AChR) or anti-muscle specific kinase (Anti-MuSK) prior to Screening
•Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable will use a highly effective method of birth control
•Male subjects must be willing to use a method of contraception

Exclusion Criteria

•Subject has previously received treatment in this study or subject has previously been exposed to UCB7665
•Subject has participated in another study of an investigational medicinal product (IMP; or a medical device) within the previous 30 days of Screening or is currently participating in another study of an investigational medicinal product (IMP; or a medical device)
•Subject has a known hypersensitivity to any components of the IMP
•Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP
•Subjects with Myasthenia Gravis (MG) only affecting the ocular muscles
•Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis
•Subject has quantitative myasthenia gravis (QMG) score of \<11 at Baseline
•Subject has a serum total immunoglobulin G (IgG) level \<= 6g/L at Screening
•Absolute neutrophil count \<1500 cells/mm\^3
•Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
+3 more criteria

Locations (20)

Mg0002 712

Los Angeles, California, United States

Mg0002 701

Orange, California, United States

Mg0002 713

Miami, Florida, United States

Mg0002 708

Tampa, Florida, United States

Mg0002 707

Augusta, Georgia, United States

Mg0002 704

Columbus, Ohio, United States

Mg0002 102

Brussels, Belgium

Mg0002 103

Ghent, Belgium

Mg0002 101

Leuven, Belgium

Mg0002 203

London, Canada

Key Dates

Start Date

May 15, 2017

Primary Completion Date

May 31, 2018

Completion Date

August 6, 2018

Last Updated

August 3, 2021

Enrollment

ACTUAL participants

Conditions

Myasthenia Gravis

Interventions

UCB7665

DRUG

Placebo

OTHER

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Myasthenia Gravis

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RECRUITING

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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: August 3, 2021Data 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.

View ClinicalTrials.gov Terms and Conditions

Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis

Inclusion Criteria

Exclusion Criteria

Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis

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

Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases

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