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

Description

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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mog001 50297, Scottsdale, Arizona, United States, 85259-5452

Palo Alto

Mog001 50450, Palo Alto, California, United States, 94304

Aurora

Mog001 50101, Aurora, Colorado, United States, 80045

Washington

Mog001 50553, Washington, District of Columbia, United States, 20057

Jacksonville

Mog001 50342, Jacksonville, Florida, United States, 32224-1865

Tampa

Mog001 50308, Tampa, Florida, United States, 33612

Peoria

Mog001 50472, Peoria, Illinois, United States, 61637

Kansas City

Mog001 50074, Kansas City, Kansas, United States, 66160

Baltimore

Mog001 50552, Baltimore, Maryland, United States, 21287

Boston

Mog001 50243, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UCB Biopharma SRL,

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

2027-07-01