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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

In brief

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 (MOGAD).

Key facts

Study ID

NCT05063162

Run by

UCB Biopharma SRL

People needed

113

Starts

2022-02-02

Expected to finish

2027-07-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
• Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD
• Participant has history of relapsing MOGAD 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

You may not qualify if…

• 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

Where it is running

• 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 50552 — Baltimore, Maryland, United States
• Mog001 50243 — Boston, Massachusetts, United States
• Mog001 50104 — Rochester, Minnesota, United States
• Mog001 50568 — San Antonio, Texas, United States
• Mog001 50473 — Salt Lake City, Utah, United States
• Mog001 30022 — Melbourne, Australia
• Mog001 40185 — Ghent, Belgium
• Mog001 60033 — Porto Alegre, Brazil
• Mog001 40195 — Hradec Králové, Czechia
• Mog001 40721 — Teplice, Czechia
• Mog001 40170 — Strasbourg, France
• Mog001 40140 — Göttingen, Germany
• Mog001 40177 — Münster, Germany
• Mog001 40850 — Athens, Greece
• Mog001 40146 — Pavia, Italy
• Mog001 40629 — Roma, Italy
• Mog001 40646 — Verona, Italy
• Mog001 20068 — Chiba, Japan
• Mog001 20307 — Isehara, Japan
• Mog001 50297 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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