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

Launched by UCB BIOPHARMA SRL · Sep 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called rozanolixizumab for adults with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD). The main goal is to see how well this medication works, how safe it is, and how well people tolerate it. The study is currently looking for participants aged 18 to 89 who have been diagnosed with MOG-AD and have experienced at least one relapse in the past year. To join the trial, participants need to be stable in their condition during the screening process.

If you or someone you know is interested in participating, it’s important to know that certain health conditions may exclude someone from the trial, such as other autoimmune diseases or serious infections. Participants will receive close monitoring and support throughout the study to ensure their safety. Overall, this trial aims to provide valuable information about a potential new treatment option for individuals affected by MOG-AD.

Gender

ALL

Eligibility 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