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

Last updated: April 24, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Rozanolixizumab

Placebo

Clinical Study ID

NCT05063162
MOG001
U1111-1301-0122
2023-509237-39
2021-000352-19
  • Ages 18-89
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥18 to ≤89 years of age, at the time of signing the informedconsent

  • Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria forMOG-AD

  • Participant has history of relapsing MOG-AD with at least 1 documented relapse overthe last 12 months and a documented positive serum MOG Ab test using a cell-basedassay (CBA) within 6 months prior to randomization

  • Participant must be clinically stable at the time of the Screening Visit and duringthe Screening Period

Exclusion

Exclusion Criteria:

  • Participant has been diagnosed with a neurological autoimmune disease (includingmultiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrumdisorder (NMOSD)), or a systemic autoimmune disease that in the opinion of theinvestigator can interfere with the safety of the participant

  • Participant has a clinically important active infection (including unresolved or notadequately treated infection) as assessed by the investigator, includingparticipants with a serious infection within 6 weeks prior to the first dose of theinvestigational 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

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Rozanolixizumab
Phase: 3
Study Start date:
February 02, 2022
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Mog001 30022

    Melbourne,
    Australia

    Active - Recruiting

  • Mog001 30026

    Southport,
    Australia

    Site Not Available

  • Mog001 40123

    Anderlecht,
    Belgium

    Active - Recruiting

  • Mog001 40756

    Bruxelles/brussel,
    Belgium

    Active - Recruiting

  • Mog001 40122

    Edegem,
    Belgium

    Active - Recruiting

  • Mog001 40185

    Gent,
    Belgium

    Active - Recruiting

  • Mog001 60033

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Mog001 40195

    Hradec Kralove,
    Czechia

    Active - Recruiting

  • Mog001 40124

    Prague 2,
    Czechia

    Site Not Available

  • Mog001 40124

    Praha 2,
    Czechia

    Active - Recruiting

  • Mog001 40721

    Teplice,
    Czechia

    Active - Recruiting

  • Mog001 40657

    Bron Cedex,
    France

    Active - Recruiting

  • Mog001 40422

    Caen,
    France

    Active - Recruiting

  • Mog001 40130

    Marseille,
    France

    Active - Recruiting

  • Mog001 40755

    Montpellier,
    France

    Active - Recruiting

  • Mog001 40170

    Strasbourg,
    France

    Active - Recruiting

  • Mog001 40659

    Berlin,
    Germany

    Active - Recruiting

  • Mog001 40140

    Göttingen,
    Germany

    Active - Recruiting

  • Mog001 40177

    Munster,
    Germany

    Active - Recruiting

  • Mog001 40177

    Münster,
    Germany

    Site Not Available

  • Mog001 40577

    ULM,
    Germany

    Active - Recruiting

  • Mog001 40146

    Pavia,
    Italy

    Active - Recruiting

  • Mog001 40629

    Roma,
    Italy

    Active - Recruiting

  • Mog001 40646

    Verona,
    Italy

    Active - Recruiting

  • Mog001 20225

    Bunkyo-ku,
    Japan

    Active - Recruiting

  • Mog001 20225

    Bunkyō-Ku,
    Japan

    Site Not Available

  • Mog001 20068

    Chiba-shi,
    Japan

    Active - Recruiting

  • Mog001 20307

    Isehara,
    Japan

    Active - Recruiting

  • Mog001 20143

    Kodaira,
    Japan

    Active - Recruiting

  • Mog001 20223

    Koriyama,
    Japan

    Active - Recruiting

  • Mog001 20223

    Kōriyama,
    Japan

    Site Not Available

  • Mog001 20224

    Sendai,
    Japan

    Active - Recruiting

  • Mog001 20227

    Sendai,
    Japan

    Active - Recruiting

  • Mog001 20070

    Shinjuku-ku,
    Japan

    Terminated

  • Mog001 20032

    Suita,
    Japan

    Active - Recruiting

  • Mog001 20226

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Mog001 20104

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Mog001 50485

    Ciudad Juárez,
    Mexico

    Site Not Available

  • Mog001 50485

    Ciudad de Mexico,
    Mexico

    Active - Recruiting

  • Mog001 50486

    Culiacán,
    Mexico

    Active - Recruiting

  • Mog001 40485

    Coimbra,
    Portugal

    Active - Recruiting

  • Mog001 40669

    Porto,
    Portugal

    Active - Recruiting

  • Mog001 40267

    Barcelona,
    Spain

    Active - Recruiting

  • Mog001 40100

    Madrid,
    Spain

    Active - Recruiting

  • Mog001 40161

    Madrid,
    Spain

    Active - Recruiting

  • Mog001 40350

    Murcia,
    Spain

    Active - Recruiting

  • Mog001 40341

    Málaga,
    Spain

    Active - Recruiting

  • Mog001 40049

    Sevilla,
    Spain

    Active - Recruiting

  • Mog001 40660

    Gothenburg,
    Sweden

    Active - Recruiting

  • Mog001 40663

    Huddinge,
    Sweden

    Terminated

  • Mog001 40723

    Basel,
    Switzerland

    Active - Recruiting

  • Mog001 40337

    Bern,
    Switzerland

    Active - Recruiting

  • Mog001 40630

    Zuerich,
    Switzerland

    Site Not Available

  • Mog001 40630

    Zurich,
    Switzerland

    Active - Recruiting

  • Mog001 20096

    Changhua City,
    Taiwan

    Active - Recruiting

  • Mog001 20096

    Changhua County,changhua CITY,
    Taiwan

    Site Not Available

  • Mog001 20303

    Kaohsuing CITY,
    Taiwan

    Active - Recruiting

  • Mog001 20080

    Taichung,
    Taiwan

    Active - Recruiting

  • Mog001 20080

    Taichung City,
    Taiwan

    Site Not Available

  • Mog001 20094

    Tainan,
    Taiwan

    Active - Recruiting

  • Mog001 20094

    Tainan City,
    Taiwan

    Site Not Available

  • Mog001 20304

    Taipei City,
    Taiwan

    Active - Recruiting

  • Mog001 20082

    Taiyuan CITY,
    Taiwan

    Active - Recruiting

  • Mog001 20082

    Taoyuan City,
    Taiwan

    Site Not Available

  • Mog001 40550

    Istanbul,
    Turkey

    Site Not Available

  • Mog001 40726

    Izmir,
    Turkey

    Active - Recruiting

  • Mog001 40648

    Samsun,
    Turkey

    Active - Recruiting

  • Mog001 40725

    Sancaktepe,
    Turkey

    Active - Recruiting

  • Mog001 40550

    İ̇stanbul,
    Turkey

    Terminated

  • Mog001 20319

    Kyiv,
    Ukraine

    Active - Recruiting

  • Mog001 20228

    Ternopil,
    Ukraine

    Active - Recruiting

  • Mog001 40661

    Liverpool,
    United Kingdom

    Active - Recruiting

  • Mog001 40163

    Oxford,
    United Kingdom

    Active - Recruiting

  • Mog001 50297

    Scottsdale, Arizona 85259-5452
    United States

    Active - Recruiting

  • Mog001 50450

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Mog001 50101

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Mog001 50553

    Washington, District of Columbia 20057
    United States

    Active - Recruiting

  • Mog001 50342

    Jacksonville, Florida 32224-1865
    United States

    Active - Recruiting

  • Mog001 50308

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Mog001 50472

    Peoria, Illinois 61637
    United States

    Active - Recruiting

  • Mog001 50074

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Mog001 50552

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Mog001 50243

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Mog001 50104

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mog001 50571

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Mog001 50304

    Dallas, Texas 75390-9036
    United States

    Active - Recruiting

  • Mog001 50568

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Mog001 50473

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

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