Meteoroid
What it found
No result yet.
What was tested
Treatment tested
- Satralizumab
IL6Ralpha/GP130 antagonist
Placebo or sham
- Placebo
What it measured
Main measures
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
Relapses
Other measures (15)
Annualized Rate of Adjudicated MOGAD Relapses
Up to approximately 44 months
RelapsesAnnualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis
Up to approximately 44 months
MRI lesionsProportion of Participants Receiving Rescue Therapy
Up to approximately 44 months
Annualized Rate of Inpatient Hospitalizations
Up to approximately 44 months
1. Rate of adjudicated MOGAD relapses
Relapses2. Active lesions on MRI of the neuroaxis (Gd-enhancing or new/enlarging T2 hyperintense lesions measured across the optic nerve, the spinal cord and the brain, including brainstem and cerebellum)
MRI lesions4. Rate of inpatient hospitalizations (defined as more than an overnight stay, excluding those for elective procedures)
5. Proportion of relapse-free participants at 6-month intervals
Relapses6. Change from baseline in total Montreal cognitive assessment (MoCA) score (adolescents only)
Thinking and memory7. Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Safety
Who could take part
MOGAD · 12 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Related trials
- TOMATO
Phase 2 / Phase 3 · Running, not recruiting
Still running
History
Started
Aug 2022
Main results due
Nov 2025
Finished
May 2028
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