Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Conditions
Brief summary
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
Interventions
DRUGSatralizumab
Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
OTHERPlacebo
Placebo will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit.
Sponsors
Hoffmann-La Roche
Chugai Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * High-contrast visual acuity (HCVA) better than 20/800 in each eye 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 satralizumab
Exclusion criteria
* Presence of aquaporin-4-antibodies immunoglobin G (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 oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses \> 20 milligrams (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 satralizumab * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC) | Up to approximately 44 months |
Secondary
| Measure | Time frame |
|---|---|
| Annualized Rate of Adjudicated MOGAD Relapses | Up to approximately 44 months |
| Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis | Up to approximately 44 months |
| Proportion of Participants Receiving Rescue Therapy | Up to approximately 44 months |
| Annualized Rate of Inpatient Hospitalizations | Up to approximately 44 months |
Countries
Australia, Brazil, Canada, France, Germany, Israel, Italy, Japan, Poland, South Korea, United States
Contacts
CONTACTReference Study ID Number: WN43194 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed