A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tiziana Life Sciences LTD
Study ID
NCT06868628
Phase
PHASE2
Status
Recruiting
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Conditions

  • Multiple System Atrophy

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Foralumab Nasal — DRUG
    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.

Study Details

A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA)

Key Dates

Start date
May 19, 2025
Status verified
Jun 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Foralumab Nasal
    This study includes a 6-month observational lead-in phase followed by a 6-month open-label treatment phase with Foralumab Nasal.

Primary Outcome Measure

Change from Screening to Month 6 in the total MDS-UMSARS score [ Time Frame: From Screening to Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
BWH Movement Disorders Research Group
[email protected]
857-307-542
Vikram Khurana, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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