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
2 other identifiers
interventional
43
7 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2017
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2018
CompletedResults Posted
Study results publicly available
August 3, 2021
CompletedAugust 3, 2021
July 1, 2021
1 year
February 10, 2017
May 28, 2021
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9
From Baseline to Visit 9 (up to Day 29)
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9
From Baseline to Visit 9 (up to Day 29)
Study Arms (2)
Dosage Regimen 1
EXPERIMENTALSubjects randomized in dosage regimen 1 will receive 3 doses of UCB7655 (dose 1) in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).
Dosage Regimen 2
EXPERIMENTALSubjects randomized in dosage regimen 2 will receive 3 doses of placebo in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).
Interventions
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)
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Mg0002 712
Los Angeles, California, 90033, United States
Mg0002 701
Orange, California, 92868, United States
Mg0002 713
Miami, Florida, 33136, United States
Mg0002 708
Tampa, Florida, 33612, United States
Mg0002 707
Augusta, Georgia, 30912, United States
Mg0002 704
Columbus, Ohio, 43210, 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
Related Publications (4)
Matic A, Alfaidi N, Bril V. An evaluation of rozanolixizumab-noli for the treatment of anti-AChR and anti-MuSK antibody-positive generalized myasthenia gravis. Expert Opin Biol Ther. 2023 Jul-Dec;23(12):1163-1171. doi: 10.1080/14712598.2023.2296126. Epub 2023 Dec 28.
PMID: 38099334DERIVEDRegnault A, Morel T, de la Loge C, Mazerolle F, Kaminski HJ, Habib AA. Measuring Overall Severity of Myasthenia Gravis (MG): Evidence for the Added Value of the MG Symptoms PRO. Neurol Ther. 2023 Oct;12(5):1573-1590. doi: 10.1007/s40120-023-00464-x. Epub 2023 May 11.
PMID: 37166675DERIVEDBril V, Benatar M, Andersen H, Vissing J, Brock M, Greve B, Kiessling P, Woltering F, Griffin L, Van den Bergh P; MG0002 Investigators. Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis: A Phase 2 Randomized Control Trial. Neurology. 2021 Feb 9;96(6):e853-e865. doi: 10.1212/WNL.0000000000011108. Epub 2020 Nov 20.
PMID: 33219142DERIVEDSmith B, Kiessling A, Lledo-Garcia R, Dixon KL, Christodoulou L, Catley MC, Atherfold P, D'Hooghe LE, Finney H, Greenslade K, Hailu H, Kevorkian L, Lightwood D, Meier C, Munro R, Qureshi O, Sarkar K, Shaw SP, Tewari R, Turner A, Tyson K, West S, Shaw S, Brennan FR. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018 Oct;10(7):1111-1130. doi: 10.1080/19420862.2018.1505464. Epub 2018 Sep 12.
PMID: 30130439DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is an Investigator- and Subject-Blind study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 14, 2017
Study Start
May 15, 2017
Primary Completion
May 31, 2018
Study Completion
August 6, 2018
Last Updated
August 3, 2021
Results First Posted
August 3, 2021
Record last verified: 2021-07