A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)
NCT ID: NCT05063162
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
104 participants
INTERVENTIONAL
2022-02-02
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rozanolixizumab Arm
Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.
Rozanolixizumab
* Pharmaceutical form: Solution for infusion
* Route of administration: subcutaneous infusion
Participants will receive pre-specified doses of rozanolixizumab.
Placebo Arm
Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.
Placebo
* Pharmaceutical form: Solution for infusion
* Route of administration: subcutaneous infusion
Participants will receive placebo.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
89 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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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 50342
Jacksonville, Florida, 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 30026
Southport, , 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 40422
Caen, , France
Mog001 40130
Marseille, , 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 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 20104
Seoul, , 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 40660
Gothenburg, , Sweden
Mog001 40663
Huddinge, , Sweden
Mog001 40723
Basel, , Switzerland
Mog001 40337
Bern, , Switzerland
Mog001 40630
Zurich, , Switzerland
Mog001 20096
Changhua, , Taiwan
Mog001 20303
Kaohsuing CITY, , Taiwan
Mog001 20080
Taichung, , Taiwan
Mog001 20094
Tainan, , Taiwan
Mog001 20304
Taipei, , Taiwan
Mog001 20082
Taoyuan, , Taiwan
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
Countries
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Central Contacts
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References
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Mader S, Kumpfel T, Meinl E. Pathomechanisms in demyelination and astrocytopathy: autoantibodies to AQP4, MOG, GFAP, GRP78 and beyond. Curr Opin Neurol. 2022 Jun 1;35(3):427-435. doi: 10.1097/WCO.0000000000001052.
Other Identifiers
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2021-000352-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509237-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1301-0122
Identifier Type: OTHER
Identifier Source: secondary_id
MOG001
Identifier Type: -
Identifier Source: org_study_id