A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)
ConditionMultiple System Atrophy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-85
SponsorTiziana Life Sciences LTD
About this trial
A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Diagnosis or suspicion of other cause for Parkinsonism or a known alternate neurologic diagnosis.
Female patient who is pregnant, lactating, breastfeeding, or planning to become pregnant during study.
Individuals with claustrophobia who cannot tolerate the study procedures
Non-MRI-compatible implanted devices.
Trial design
Design model
Single group
Treatments tested in this trial
Foralumab Nasal
DrugForalumab 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Foralumab NasalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Screening to Month 6 in the total MDS-UMSARS score
Time frame
From Screening to Month 62
Change in TSPO activity as measured by [F-18]PBR06 retention calculated over whole brain and within key regions of interest (ROIs) at 6 months as compared to screening
Time frame
From Screening to Month 6Secondary outcomes
1
Change from Screening to Month 6 in MDS-UMSARS Part III (motor examination) score
Time frame
From Screening to Month 62
Proportion of patients with ≥30% improvement in MDS-UMSARS total score at Month 6
Time frame
From Screening to Month 63
Change from Screening to Month 6 in COMPASS-31 total score
Time frame
From Screening to Month 64
Change from Screening to Month 6 in MSA-QoL summary index score
Time frame
From Screening to Month 6Sponsors and contacts
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Source ClinicalTrials.gov