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

Completed · Phase 2 · Has a placebo group

Conditions studied: Myasthenia Gravis

In brief

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.

Key facts

Study ID: NCT03052751
Run by: UCB Biopharma S.P.R.L.
People needed: 43
Starts: 2017-05-15
Expected to finish: 2018-08-06
Last updated by the study team: 2021-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject's ability to participate in this study
Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)

Where it is running

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
Mg0002 202 — Montreal, Canada
Mg0002 201 — Toronto, Canada
Mg0002 302 — Ostrava-Poruba, Czechia
Mg0002 401 — Aarhus, Denmark
Mg0002 402 — Copenhagen, Denmark
Mg0002 505 — Düsseldorf, Germany
Mg0002 502 — Gummersbach, Germany
Mg0002 501 — Jena, Germany
Mg0002 601 — Barcelona, Spain
Mg0002 602 — Barcelona, Spain

Full record on ClinicalTrials.gov

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