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

NCT05063162 · tracked via the Priya Life Science UK tracker

Sponsor

UCB Biopharma SRL

Phase

Phase 3

Started

2022-02-02

Last updated

2026-08-27

Condition(s) studied

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Investigational drug(s) / intervention(s)

RozanolixizumabPlacebo

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.

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 (MOGAD).

Eligibility

Sex

ALL

Min age

18 Years

Max age

89 Years

Healthy volunteers

Inclusion Criteria: * 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 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

Primary outcome measure(s)

For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period — Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
The TTFR (days) will be defined as the interval between the date of randomization and the first date of the objective relapse. During the Double Blind (DB) Treatment Period (Part A); EDB/EWD = End of Double-Blind/Early Withdrawal Visit
For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period — OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Open-Label Extension (OLE) Treatment Period (Part B); EOS/EWD = End of Study/Early Withdrawal Visit.
For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period — OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.

Trial sites (55)

Facility	City	Region
Mog001 50297	Scottsdale	Arizona
Mog001 50450	Palo Alto	California
Mog001 50101	Aurora	Colorado
Mog001 50553	Washington D.C.	District of Columbia
Mog001 50308	Tampa	Florida
Mog001 50472	Peoria	Illinois
Mog001 50552	Baltimore	Maryland
Mog001 50243	Boston	Massachusetts
Mog001 50104	Rochester	Minnesota
Mog001 50568	San Antonio	Texas
Mog001 50473	Salt Lake City	Utah
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 20049	Kitakyushu	Japan
Mog001 20143	Kodaira	Japan
Mog001 20223	Koriyama-shi	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 40161	Madrid	Spain

+ 15 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05063162 on ClinicalTrials.gov ↗ ← All trials in the UK