A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)
Tiziana Life Sciences LTD
Summary
A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)
Eligibility
- Age range
- 30–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects with a clinical diagnosis of Clinically Established or Clinically Probable Multiple System Atrophy in accordance with 2022 MDS diagnostic criteria. * Age 30 to 85 years, at the time of signing the informed consent. * Stable dopaminergic treatment for at least 4 weeks before enrollment. * Adequate hematologic parameters without ongoing transfusion support: Hemoglobin (Hb) ≥ 9 g/dL; Platelets ≥ 100 x 109 cells/L. * Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula. * Tota…
Interventions
- DrugForalumab Nasal
Foralumab is an anti-CD3 monoclonal antibody administered as a nasal spray. Participants will complete eight 3-week dosing cycles over the study. During each cycle, Foralumab will be administered intranasally three times per week for the first two weeks, with no administration in the third week.
Location
- Brigham and Women's HospitalBoston, Massachusetts