A study to evaluate the efficacy and safety of rozanolixizumab in adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD)

Phase 1

• Conditions: Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD); MedDRA version: 20.0Level: HLTClassification code 10012302Term: Demyelinating disorders NECSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000352-19-BE
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-04
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

- Participants 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 cellbased 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy of rozanolixizumab for treatment of participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD);Secondary Objective: Assess the safety and tolerability of rozanolixizumab in participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD);Primary end point(s): For Part A:<br>1. Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period<br>For Part B:<br>2. Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period<br>3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period;Timepoint(s) of evaluation of this end point: 1. Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks)<br>2, 3: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)