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

UCB

Status and phase: Enrolling; Phase 3

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

Treatments: Other: Placebo; Drug: Rozanolixizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05063162

2023-509237-39 (Registry Identifier)

2021-000352-19 (EudraCT Number)

MOG001

U1111-1301-0122 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Rozanolixizumab Arm

Experimental group

Description:

Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.

Treatment:

Drug: Rozanolixizumab

Placebo Arm

Placebo Comparator group

Description:

Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.

Treatment:

Other: Placebo