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
    

HORIZON (23-0315)

• Investigator: Amanda Piquet, MD
• Purpose: to assess pregnancy and birth outcomes in women with Neuromyelitis Optica Spectrum Disorder (also known as NMOSD), who received inebilizumab (commercially available as “UPLIZNA”) during pregnancy, or within 6 months before getting pregnant.
• Procedure: during the study, the following information will be collected: contact information, medical and family history, pregnancy data (lifestyle, how you got pregnant, last menstrual period, estimated date of delivery, etc.), current NMOSD disease status and your baby’s data (date of birth, general health status, weight, etc.).
• Timeline: in order to collect this data, you and/or the doctor taking care of your pregnancy and/or your baby will be contacted approximately 4 times by the site.
• Key Eligibility Criteria:
  • Diagnosis: Neuromyelitis Optica Spectrum Disorder (NMOSD)
  • Are a female of reproductive potential
  • Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception
    

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)