Loading clinical trials...

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

ACTIVE_NOT_RECRUITINGPHASE3

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

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)

NCT05063162•UCB Biopharma SRL

View on ClinicalTrials.gov

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

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

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

Locations (73)

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 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

Key Dates

Start Date

February 2, 2022

Primary Completion Date

May 6, 2027

Completion Date

July 1, 2027

Last Updated

March 13, 2026

Enrollment

104

ESTIMATED participants

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)

Interventions

Rozanolixizumab

DRUG

Placebo

OTHER