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

• Status: Not yet recruiting
• Trial end date: 2025-07-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma SRL
• Treatments: Rozanolixizumab

Criteria

Inclusion Criteria:

• Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent

• Participant must have a history of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) with any of the following clinical presentations:

1. Optic neuritis (single, recurrent, or simultaneous bilateral)

2. Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM))

3. Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis

4. Combined presentations

• Positivity for serum MOG-Immunglobulin G (IgG) antibodies using cell-based assay at Screening

• Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 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 relevant active infection (eg, sepsis, pneumonia, or abscess), or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)

• Participant has a current or medical history of primary immunodeficiency

• Participant has a current or medical history of IgA deficiency

• Participant tests positive for aquaporin-4 antibodies at screening

• Participant has a serum total IgG level ≤ 5.5g/L