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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03052751
• Date of registration: 10/02/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis.
• Scientific title: 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
• Date of first enrolment: May 15, 2017
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03052751
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Czechia, Denmark, Germany, Spain, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

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

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Other: Placebo

Drug: UCB7665

Primary Outcome(s)

Change from Baseline in Quantitative Myasthenia Gravis (QMG) score to Visit 9 [Time Frame: Baseline and Visit 9 (Day 29)]

Secondary Outcome(s)

Change from Baseline in Myasthenia Gravis-Composite score to Visit 9 [Time Frame: Baseline and Visit 9 (Day 29)]

Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) score to Visit 9 [Time Frame: Baseline and Visit 9 (Day 29)]

Secondary ID(s)

2016-002698-36

MG0002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors