NEURO-OPHTHALMOLOGY RESEARCH

METEOROID (23-0648)

• Investigator: Jeffrey Bennett, MD, PhD
• Purpose: to compare the effects, good or bad, of satralizumab with placebo alone or in combination with current treatment (baseline/background therapy) on participants with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD).
• Intervention: satralizumab (50% chance) or placebo (50% chance).
• Timeline: Screening Period (approx. 28 days), Double-Blind Period, Open-Label Period (approx. 2 years), and Follow-Up Period (12 weeks if you are an adult and 24 weeks if you are an adolescent (12 to 17 years old)).  Total study participation: up to 5 years.
• ClinicalTrials.gov Identifier: NCT05271409
• Key Eligibility Criteria: age: ≥ 12, diagnosis: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD), body weight: 20kg at screening. 

UCB MOG (21-3747)

• Investigator: Jeffrey Bennett, MD, PhD
• Purpose: to assess how safe, tolerable (acceptable to you) and effective rozanolixizumab (referred to as “the study drug” hereafter) is in treating Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOG-AD).
• Intervention: study drug (50% chance) or placebo (50% chance).
• Timeline: Screening Period (approx. 4 to 6 weeks) followed by a Double-Blind Study Treatment Period (up to 132 weeks) followed by a Open-Label Extension (OLE) Study Treatment Period (approx. 51 weeks) followed by a Safety Follow-Up (SFU) Period (8 weeks after the last dose of study treatment).
• ClinicalTrials.gov Identifier: NCT05063162
•  Key Eligibility Criteria: age: ≥18 to ≤89 years old, diagnosis: Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOG-AD), weigh at least 35kg at Screening.
  

SAkuraBONSAI (21-4079)

• Investigator: Jeffrey Bennett, MD, PhD
• Purpose: to test the efficacy and safety of satralizumab in subjects who have not received any maintenance treatment with Neuromyelitis Optica Spectrum Disorder (NMOSD), as well as subjects who have been treated with rituximab but have an inadequate response to it.
• Intervention: satralizumab
• Timeline: Screening Period followed by a Study Treatment Period involving subcutaneous (under the skin) injections of satralizumab 120 mg at Weeks 0, 2, and 4 and every 4 weeks till the last injection at Week 92 followed by a visit to the clinic at Week 96. Total study participation is approx. 2.5 years.
• ClinicalTrials.gov Identifier: NCT05269667 
• Key Eligibility Criteria: age: 18 to 74 years (inclusive), diagnosis: AQP4 antibody seropositive Neuromyelitis Optica Spectrum Disorder (NMOSD)
  

SAkuraPEAK (22-1981)

• Investigator: Jeffrey Bennett, MD, PhD
• Purpose: to test Satralizumab at a higher dose (180 mg) in Neuromyelitis Optica Spectrum Disorder (NMOSD) participants weighing more than 100 kg to find out if this dose is safe and to understand the way their body processes the study drug.
• Intervention: Satralizumab.
• Timeline: Screening Visit followed by a 24-week study treatment period (~10 in-person visits) followed by a 12-week follow-up (~2 telephone visits + 1 final in-person visit).
• ClinicalTrials.gov Identifier: NCT02073279
• Key Eligibility Criteria: age: 18+ years old, diagnosis: AQP4 antibody-positive NMOSD, body Weight: over 100kg (~220 lbs)