Actively Recruiting

Phase 2
Age: 30Years - 85Years
All Genders
ID06868628

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

Led by Tiziana Life Sciences LTD · Updated on 2025-09-23

5

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the safety, clinical effects, and microglial activation in patients with Multiple System Atrophy (MSA) using Foralumab Nasal. The study is a Phase 2a trial sponsored by Tiziana Life Sciences LTD, focusing on patients aged 30 to 85 years with a diagnosis of clinically established or probable MSA. It measures changes in motor symptoms and brain activity over the course of the study. Participants will first enter a 6-month observational phase without treatment, followed by a 6-month open-label phase where they receive Foralumab Nasal. This drug is an anti-CD3 monoclonal antibody given as a nasal spray. Treatment involves eight 3-week dosing cycles, each with three doses per week for two weeks, followed by a week without dosing. During the study, participants will undergo various assessments including motor function tests, brain scans to measure TSPO activity and brain volume changes, and quality of life questionnaires. Safety and clinical effects will be closely monitored, with the total study duration lasting 12 months. The primary outcomes focus on changes in MDS-UMSARS scores and TSPO activity from screening to month 6.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 30Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Clinically Established or Probable Multiple System Atrophy as per 2022 MDS criteria
  • Age between 30 and 85 years at consent
  • Stable dopaminergic treatment for at least 4 weeks before enrollment
  • Hemoglobin level at least 9 g/dL and platelets at least 100 x 10^9 cells/L
  • Creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 60 mL/min/1.73 m2
  • Total bilirubin less than or equal to 2 times upper limit of normal unless due to Gilbert's disease
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal
  • QTcF interval less than or equal to 470 msec for women and 450 msec for men on screening ECG
  • Negative urine pregnancy test within 7 days prior to first dose for women of child-bearing potential
  • Agreement to use effective contraception during study and for 90 days after treatment
  • Up-to-date immunizations as assessed by primary care physician and neurologist
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis or suspicion of other Parkinsonism causes or alternate neurologic diagnoses
  • Female patients who are pregnant, lactating, breastfeeding, or planning pregnancy during study
  • Claustrophobia preventing study procedures
  • Non-MRI-compatible implanted devices
  • Low-affinity binders for TSPO PET ligands
  • Systemic corticosteroid treatment within past 4 weeks (excluding nasal/local treatments)
  • Significant cognitive impairment (MoCA score 20 or less)
  • Brain MRI abnormalities interfering with PET-MRI co-registration
  • Serious cardiac conditions within last 6 months including uncontrolled arrhythmia, myocardial infarction, unstable angina, NYHA Class III/IV heart disease, or hereditary long QT syndrome
  • Use of medications causing QTc prolongation or Torsades de Pointes unless essential and standard care
  • Positive tests for HIV, hepatitis B, hepatitis C, or positive EBV IgM at screening
  • History of hematologic or solid malignancy
  • Treatment with chronic immunosuppressives within past 90 days
  • Inability to tolerate nasal medications
  • Nasal corticosteroids, antihistamines, or flu dosing within past 30 days or anticipated need during study
  • Chronic rhinitis, deviated septum, nasal polyps, or sinusitis treated within past 8 months
  • Autoimmune diseases including inflammatory bowel disease, rheumatoid arthritis, lupus, Sjögren's syndrome, asthma, or type 1 diabetes
  • Neutropenia with absolute neutrophil count below 1,000 cells/mL or severe immunosuppression
  • Severe lymphopenia with lymphocyte count below 500 cells/mL
  • History of gadolinium allergy
  • Recent active infection needing antibiotics within past 15 days
  • Any other medical or surgical condition compromising study adherence or result interpretation
  • Unable or unwilling to comply with protocol
  • Active COVID-19 disease
  • COVID-19 vaccine within past 10 days or other vaccine within past 7 days at dosing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observational Lead-in

Duration - 6 months

Participants are observed for 6 months prior to starting treatment.

Visits as scheduled for observation during lead-in phase

Treatment

Duration - 6 months

Participants receive Foralumab Nasal administered intranasally three times per week for two weeks followed by one week off, repeated over eight 3-week dosing cycles during a 6-month treatment phase.

Three times per week dosing for first two weeks of each 3-week cycle, repeated for 8 cycles

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

B

Brigham and Women's Hospital Movement Research Team

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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https://pubmed.ncbi.nlm.nih.gov/38630948

An 18-kDa translocator protein (TSPO) polymorphism explains differences in binding affinity of the PET radioligand PBR28.

David R Owen, Astrid J Yeo, Roger N Gunn...

https://pubmed.ncbi.nlm.nih.gov/22008728

Clinical Trial-Ready Patient Cohorts for Multiple System Atrophy: Coupling Biospecimen and iPSC Banking to Longitudinal Deep-Phenotyping.

Alain Ndayisaba, Ariana T Pitaro, Andrew S Willett...

https://pubmed.ncbi.nlm.nih.gov/36190676

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