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

September 18, 2025 updated by: Tiziana Life Sciences LTD

A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Vikram Khurana, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN.
  • QT interval corrected for rate (QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening.
  • Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male patients must agree to use highly effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 90 days after the completion of study treatment.
  • Patients whose immunizations are fully up to date at the Screening, according to the assessment of their primary care physician and neurologist.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • 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.
  • Low-affinity binders for translocator protein (TSPO) PET ligands.
  • Systemic corticosteroid treatment in the past four weeks (excluding nasal or local treatment).
  • Individuals with significant cognitive impairment (i.e., MoCA score less than or equal to 20).
  • Brain MRI indicative of significant abnormalities that interfere with PET-MRI co-registration (i.e., large prior hemorrhage or multiple infarcts).
  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina, or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome.
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
  • Patients who test positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or positive Epstein-Barr virus (EBV) IgM at the Screening Visit.
  • Past medical history of a hematologic or solid malignancy.
  • Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, Siponimod, dimethyl fumarate, or natalizumab within the past 90 days.
  • Inability to tolerate nasally administered medications.
  • Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days, or anticipated need during the study.
  • Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 8 months.
  • Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's Syndrome, asthma, or type 1 diabetes.
  • Neutropenia or an absolute neutrophil count of < 1,000 cells/mL or other indicators of severe immunosuppression.
  • Severe lymphopenia or an absolute lymphocyte count of < 500 cells/mL
  • Patients with a history of gadolinium allergy.
  • A recent clinically significant active infection requiring treatment with antibiotics or other anti-infective agents within the past 15 days.
  • Any other medical or surgical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.
  • Unable or unwilling to comply with protocol requirements.
  • Active COVID-19 disease.
  • COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Foralumab 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Screening to Month 6 in MDS-UMSARS Part III (motor examination) score
Time Frame: From Screening to Month 6
From Screening to Month 6
Proportion of patients with ≥30% improvement in MDS-UMSARS total score at Month 6
Time Frame: From Screening to Month 6
From Screening to Month 6
Change from Screening to Month 6 in COMPASS-31 total score
Time Frame: From Screening to Month 6
From Screening to Month 6
Change from Screening to Month 6 in MSA-QoL summary index score
Time Frame: From Screening to Month 6
From Screening to Month 6
Percent whole brain volume change (PWBVC) between screening and 6 months
Time Frame: From Screening to Month 6
From Screening to Month 6
Percent putamen volume change (PPVC) between screening and 6 months
Time Frame: From Screening to Month 6
From Screening to Month 6
Percent cerebellar volume change (PCVC) between screening and 6 months
Time Frame: From Screening to Month 6
From Screening to Month 6
Percent pontine volume change (PPoVC) between screening and 6 months
Time Frame: From Screening to Month 6
From Screening to Month 6
Percent midbrain volume change (PMVC) between screening and 6 months
Time Frame: From Screening to Month 6
From Screening to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tiziana Life Sciences LTD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P000259

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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