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A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)
Sponsor: UCB Biopharma SRL
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2022-02-02
Completion Date
2027-07-01
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Rozanolixizumab
* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive pre-specified doses of rozanolixizumab.
Placebo
* Pharmaceutical form: Solution for infusion * Route of administration: subcutaneous infusion Participants will receive placebo.
Locations (73)
Mog001 50297
Scottsdale, Arizona, United States
Mog001 50450
Palo Alto, California, United States
Mog001 50101
Aurora, Colorado, United States
Mog001 50553
Washington D.C., District of Columbia, United States
Mog001 50308
Tampa, Florida, United States
Mog001 50472
Peoria, Illinois, United States
Mog001 50074
Kansas City, Kansas, United States
Mog001 50552
Baltimore, Maryland, United States
Mog001 50243
Boston, Massachusetts, United States
Mog001 50104
Rochester, Minnesota, United States
Mog001 50571
Cleveland, Ohio, United States
Mog001 50304
Dallas, Texas, United States
Mog001 50568
San Antonio, Texas, United States
Mog001 50473
Salt Lake City, Utah, United States
Mog001 30022
Melbourne, Australia
Mog001 40123
Anderlecht, Belgium
Mog001 40756
Bruxelles/brussel, Belgium
Mog001 40122
Edegem, Belgium
Mog001 40185
Ghent, Belgium
Mog001 60033
Porto Alegre, Brazil
Mog001 40195
Hradec Králové, Czechia
Mog001 40124
Prague, Czechia
Mog001 40721
Teplice, Czechia
Mog001 40657
Bron, France
Mog001 40755
Montpellier, France
Mog001 40170
Strasbourg, France
Mog001 40659
Berlin, Germany
Mog001 40386
Cologne, Germany
Mog001 40140
Göttingen, Germany
Mog001 40177
Münster, Germany
Mog001 40577
Ulm, Germany
Mog001 40850
Athens, Greece
Mog001 40851
Thessaloniki, Greece
Mog001 40146
Pavia, Italy
Mog001 40629
Roma, Italy
Mog001 40646
Verona, Italy
Mog001 20225
Bunkyō City, Japan
Mog001 20068
Chiba, Japan
Mog001 20307
Isehara, Japan
Mog001 20049
Kitakyushu, Japan
Mog001 20143
Kodaira, Japan
Mog001 20223
Kōriyama, Japan
Mog001 20224
Sendai, Japan
Mog001 20227
Sendai, Japan
Mog001 20070
Shinjuku-ku, Japan
Mog001 20032
Suita, Japan
Mog001 50486
Culiacán, Mexico
Mog001 50485
Mexico City, Mexico
Mog001 40840
Bydgoszcz, Poland
Mog001 40485
Coimbra, Portugal
Mog001 40669
Porto, Portugal
Mog001 20226
Goyang-si, South Korea
Mog001 40267
Barcelona, Spain
Mog001 40100
Madrid, Spain
Mog001 40161
Madrid, Spain
Mog001 40341
Málaga, Spain
Mog001 40350
Murcia, Spain
Mog001 40049
Seville, Spain
Mog001 40663
Huddinge, Sweden
Mog001 40723
Basel, Switzerland
Mog001 40337
Bern, Switzerland
Mog001 40630
Zurich, Switzerland
Mog001 20080
Taichung, Taiwan
Mog001 20094
Tainan, Taiwan
Mog001 40849
Bursa, Turkey (Türkiye)
Mog001 40550
Istanbul, Turkey (Türkiye)
Mog001 40726
Izmir, Turkey (Türkiye)
Mog001 40648
Samsun, Turkey (Türkiye)
Mog001 40725
Sancaktepe, Turkey (Türkiye)
Mog001 20319
Kyiv, Ukraine
Mog001 20228
Ternopil, Ukraine
Mog001 40661
Liverpool, United Kingdom
Mog001 40163
Oxford, United Kingdom