Two Clinical Trials Recruiting for MOGAD and NMOSD

Research is imperative for the development of new therapies for rare neuroimmune disorders. There are two research studies currently being conducted by Hoffmann-La Roche for treatment of NMOSD and MOGAD: SAkuraSun and Meteoroid. See below for information on each study.

SAkuraSun

The first study is named “A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD).” This study, nicknamed “SAkuraSun”, will test the use of satralizumab in children aged 2-11 years who have been diagnosed with neuromyelitis optica spectrum disorder (NMOSD). Participants must be positive for the anti-aquaporin-4 (AQP4) antibody. This is a phase III trial, and if successful, may allow Satralizumab to be submitted for FDA approval for pediatric patients with AQP4-positive NMOSD.

This study is currently recruiting and will consist of approximately 8 participants. There will be three arms, or subgroups, of the study: participants weighing 10kg to <20kg, participants weighing 20kg to <40kg, and participants weighing more than 40kg. Each participant will receive satralizumab treatment for a minimum of 48 weeks and then will have the option to continue satralizumab for a longer period of time.

More information about the study can be found on the clinical trial site here. For more information, please contact the study administrator at [email protected] or call 888-662-6728.

Meteoroid

The other study is named “A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease.” This study, nicknamed “Meteoroid”, will test the use of satralizumab in children and adults with MOG antibody disease (MOGAD) aged 12 years and older. Participants must have a confirmed diagnosis of MOGAD with a history of at least 1 relapse in the 12 months prior to screening for the study, or 2 or more attacks in the 24 months prior to screening for the study. This is a phase III trial, and if successful, may allow satralizumab to be submitted for FDA approval for patients with MOGAD aged 12 years and older.

This study is currently recruiting and will consist of about 152 participants. There will be two arms, or subgroups, of the study: treatment and placebo. Participants in the treatment arm will receive loading doses of satralizumab at weeks 0, 2, and 4 of the study and maintenance doses every 4 weeks thereafter. Participants in the placebo arm will receive doses of placebo at weeks 0, 2, and 4 of the study and placebo doses every 4 weeks thereafter. Both arms will receive open label treatment with satralizumab during the open-label extension (OLE) period of the study.

More information about the study can be found on the clinical trial site here. For more information, please contact the study administrator at [email protected] or call 888-662-6728.