A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)
Status: Active_not_recruiting
Location: See all (70) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Mog001 50297
Scottsdale
California
Mog001 50450
Palo Alto
Colorado
Mog001 50101
Aurora
Washington, D.c.
Mog001 50553
Washington D.c.
Florida
Mog001 50308
Tampa
Illinois
Mog001 50472
Peoria
Kansas
Mog001 50074
Kansas City
Massachusetts
Mog001 50243
Boston
Maryland
Mog001 50552
Baltimore
Minnesota
Mog001 50104
Rochester
Ohio
Mog001 50571
Cleveland
Texas
Mog001 50304
Dallas
Mog001 50568
San Antonio
Utah
Mog001 50473
Salt Lake City
Other Locations
Australia
Mog001 30022
Melbourne
Belgium
Mog001 40123
Anderlecht
Mog001 40756
Bruxelles/brussel
Mog001 40122
Edegem
Mog001 40185
Ghent
Brazil
Mog001 60033
Porto Alegre
France
Mog001 40657
Bron
Mog001 40755
Montpellier
Mog001 40170
Strasbourg
Germany
Mog001 40659
Berlin
Mog001 40386
Cologne
Mog001 40140
Göttingen
Mog001 40177
Münster
Mog001 40577
Ulm
Greece
Mog001 40850
Athens
Mog001 40851
Thessaloniki
Italy
Mog001 40146
Pavia
Mog001 40629
Roma
Mog001 40646
Verona
Japan
Mog001 20225
Bunkyō City
Mog001 20068
Chiba
Mog001 20307
Isehara
Mog001 20049
Kitakyushu
Mog001 20143
Kodaira
Mog001 20223
Kōriyama
Mog001 20224
Sendai
Mog001 20227
Sendai
Mog001 20070
Shinjuku-ku
Mog001 20032
Suita
Mexico
Mog001 50486
Culiacán
Mog001 50485
Mexico City
Poland
Mog001 40840
Bydgoszcz
Portugal
Mog001 40485
Coimbra
Mog001 40669
Porto
Republic of Korea
Mog001 20226
Goyang-si
Spain
Mog001 40267
Barcelona
Mog001 40100
Madrid
Mog001 40161
Madrid
Mog001 40341
Málaga
Mog001 40350
Murcia
Mog001 40049
Seville
Sweden
Mog001 40663
Huddinge
Switzerland
Mog001 40723
Basel
Mog001 40337
Bern
Mog001 40630
Zurich
Taiwan
Mog001 20080
Taichung
Mog001 20094
Tainan
Turkey
Mog001 40849
Bursa
Mog001 40550
Istanbul
Mog001 40726
Izmir
Mog001 40648
Samsun
Mog001 40725
Sancaktepe
Ukraine
Mog001 20319
Kyiv
Mog001 20228
Ternopil
United Kingdom
Mog001 40661
Liverpool
Mog001 40163
Oxford
Time Frame
Start Date: 2022-02-02
Completion Date: 2027-07-01
Participants
Target number of participants: 104
Treatments
Experimental: Rozanolixizumab Arm
Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.
Placebo_comparator: Placebo Arm
Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL