This is a Global, Multicentre Phase III, Randomised, Double-Blind Clinical Trial.

The study will include over 150 adults and adolescents (12-18 years of age) with MOGAD from around the world. Participants will be randomly assigned between treatment arms.

In Australia 8 sites will participate in the study, 4 in NSW, 3 in Victoria and 1 in Western Australia.

•Participants who are aged >=12 years at the time of signing Informed Consent Form
•Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
•Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
•Best corrected visual acuity (BCVA) better than 20/800 in both eyes at screening
•Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
•For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of investigational product

•Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
•History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
•Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study
•Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of investigational product
•Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
•Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
•Participants with positive screening tests for hepatitis B and C
•Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
•History of severe allergic reaction to a biologic agent

Currently Recruiting

John Hunter Hospital, NSW
Investigator Is Dr Jeanette Lechner-Scott, Site contact is Nicole Lingard, Nicole.Lingard@health.nsw.gov.au

Royal North Shore Hospital, NSW
Investigator Is Dr John Parratt, Site contact is Katherine Markoulis, katherine.markoulis@health.nsw.gov.au
Brain and Mind Centre, NSW
Investigator Is Dr Stephen Reddel, Site contact is Marinda Taha, marinda.taha@sydney.edu.au
Box Hill Hospital, VIC
Investigator Is Dr Katherine Buzzard, Site contact is Carly Shaddick, carly.shaddick@monash.edu
Royal Melbourne Hospital, NSW
Investigator Is Dr Ai-Lan Nguyen, Site contact is Hasini Fernando, Hasini.Fernando@mh.org.au

Full details of the trial can be found on clinicaltrials.gov https://clinicaltrials.gov/study/NCT05271409?cond=Myelin%20oligodendrocyte%20glycoprotein%20antibody%20disorder&rank=1

NSW/VIC – more sites to come soon

Yes

25/09/2023