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

Myasthenia Gravis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052751
• Other study ID #: MG0002
• Secondary ID: 2016-002698-36
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2017
• Est. completion date: August 6, 2018

Study information

• Verified date: July 2021
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 6, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• UCB7665
UCB7665 will be administered in 2 different dosages (dose 1 and dose 2). UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)

Other:
• Placebo
Placebo will be administered in period 1 of dosage regimen 2.

Locations

Country	Name	City	State
Belgium	Mg0002 102	Bruxelles
Belgium	Mg0002 103	Gent
Belgium	Mg0002 101	Leuven
Canada	Mg0002 203	London
Canada	Mg0002 202	Montréal
Canada	Mg0002 201	Toronto
Czechia	Mg0002 302	Ostrava-Poruba
Denmark	Mg0002 401	Aarhus
Denmark	Mg0002 402	Copenhagen
Germany	Mg0002 505	Düsseldorf
Germany	Mg0002 502	Gummersbach
Germany	Mg0002 501	Jena
Spain	Mg0002 601	Barcelona
Spain	Mg0002 602	Barcelona
United States	Mg0002 707	Augusta	Georgia
United States	Mg0002 704	Columbus	Ohio
United States	Mg0002 712	Los Angeles	California
United States	Mg0002 713	Miami	Florida
United States	Mg0002 701	Orange	California
United States	Mg0002 708	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9	The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.	From Baseline to Visit 9 (up to Day 29)
Secondary	Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9	The total Myasthenia Gravis (MG)-composite score was obtained by summing the responses to each individual item (10 items; Grade: 0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.	From Baseline to Visit 9 (up to Day 29)
Secondary	Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9	The total MGDAL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.	From Baseline to Visit 9 (up to Day 29)