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Active (not recruiting) Phase 3 NCT05063162

A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)

Phase 3 – large-scale trial before approval
Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).
Who can participate
Inclusion Criteria: * Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent * Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD * Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization * Participant must be clinically stable at the time of the Screening Visit and during the Screening Period Exclusion Criteria: * Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant * Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP) * Participant has a current or medical history of primary immunodeficiency * Participant tests positive for aquaporin-4 antibodies at Screening * Participant has a serum total IgG level ≤ 5.5g/L
Locations 19
Australia (1)
Mog001 30022
Melbourne
Belgium (1)
Mog001 40123
Anderlecht
Brazil (1)
Mog001 60033
Porto Alegre
Czech Republic (1)
Mog001 40195
Hradec Králové
France (1)
Mog001 40657
Bron
Germany (1)
Mog001 40659
Berlin
Greece (1)
Mog001 40850
Athens
Italy (1)
Mog001 40146
Pavia
Japan (1)
Mog001 20225
Bunkyō City
Mexico (1)
Mog001 50486
Culiacán
Poland (1)
Mog001 40840
Bydgoszcz
South Korea (1)
Mog001 20226
Goyang-si
Spain (1)
Mog001 40267
Barcelona
Sweden (1)
Mog001 40663
Huddinge
Taiwan (1)
Mog001 20080
Taichung
Turkey (1)
Mog001 40849
Bursa
Ukraine (1)
Mog001 20319
Kyiv
United Kingdom (1)
Mog001 40661
Liverpool
United States (1)
Mog001 50297
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
89 Years
Healthy volunteers
No
Start date
02.02.2022
Completion date
01.07.2027
Registry ID
NCT05063162
Source
anzctr
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