MOG001
MOG001
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)
Brief 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).
Medical Condition
Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)
Min. Age
18
Years
Max. Age
89
Years
Who Can Join?
All
Status
Recruiting
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: a) Optic neuritis (single, recurrent, or simultaneous bilateral) b) Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM)) c) Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis d) 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
Study Medication Description
Study Medication:
Rozanolixizumab
Other Descriptive Name:
rozanolixizumab
Placebo
Yes
Comparator:
No
Refer to a friend
Study Dates
February 2022
Actual Start Date of Enrollment
July 2025
Planned Study Completion Date
General Information
Study ID:
MOG001
EudraCT Number:
2021-000352-19
CT.gov Number:
NCT05063162
Phase:
Phase 3