RECRUITING

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

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)MOG MOGAD Rozanolixizumab Myelin oligodendrocyte glycoprotein Myelin oligodendrocyte glycoprotein antibody-associated disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2022-02-02

Study Completion:2027-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05063162

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.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

UCB Cares

CONTACT

1-844-599-2273 (USA)

UCBCares@ucb.com

UCB Cares

CONTACT

001 844 599 2273

UCBCares@ucb.com

Principal Investigator

UCB Cares

STUDY_DIRECTOR

001 844 599 2273

Study Locations (Sites)

Mog001 50297

Scottsdale, Arizona, 85259-5452

United States

Mog001 50450

Palo Alto, California, 94304

United States

Mog001 50101

Aurora, Colorado, 80045

United States

Mog001 50553

Washington, District of Columbia, 20057

United States

Mog001 50342

Jacksonville, Florida, 32224-1865

United States

Mog001 50308

Tampa, Florida, 33612

United States

Mog001 50472

Peoria, Illinois, 61637

United States

Mog001 50074

Kansas City, Kansas, 66160

United States

Mog001 50552

Baltimore, Maryland, 21287

United States

Mog001 50243

Boston, Massachusetts, 02114

United States

Mog001 50104

Rochester, Minnesota, 55905

United States

Mog001 50571

Cleveland, Ohio, 44106

United States

Mog001 50568

San Antonio, Texas, 78229

United States

Mog001 50473

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-02

Study Completion Date2027-07-01

Study Record Updates

Study Start Date2022-02-02

Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

MOG
MOGAD
Rozanolixizumab
Myelin oligodendrocyte glycoprotein
Myelin oligodendrocyte glycoprotein antibody-associated disease

Additional Relevant MeSH Terms

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