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Evaluating Rozanolixizumab for treating MOG antibody-associated disease in adults

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)

PHASE3 · UCB Pharma · NCT05063162

This study is testing if a new treatment called Rozanolixizumab can help adults with MOG antibody-associated disease feel better and manage their symptoms compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment104 (estimated)
Ages18 Years to 89 Years
SexAll
SponsorUCB Pharma (industry)
Drugs / interventionsrozanolixizumab
Locations77 sites (Scottsdale, Arizona and 76 other locations)
Trial IDNCT05063162 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of Rozanolixizumab in adult participants diagnosed with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD). Participants aged 18 to 89 with a history of relapsing MOG-AD and a documented positive serum MOG antibody test will be enrolled. The study will compare the effects of Rozanolixizumab against a placebo in a Phase 3 interventional setting. The goal is to determine if this treatment can effectively manage the symptoms and progression of MOG-AD.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 89 with a confirmed diagnosis of relapsing MOG-AD and a recent positive MOG antibody test.

Not a fit: Patients with other neurological autoimmune diseases or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from MOG-AD, potentially improving their quality of life.

How similar studies have performed: While this approach is novel for MOG-AD, similar studies targeting other autoimmune conditions have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Scottsdale, Arizona and 76 other locations

+27 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, MOG, MOGAD, Rozanolixizumab, Myelin oligodendrocyte glycoprotein, Myelin oligodendrocyte glycoprotein antibody-associated disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.