NCT06292923

A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Recruiting now Phase 2 Last updated 10 October 2025

What this trial tests

Phase 2 trial testing Foralumab in Secondary Progressive Multiple Sclerosis in 54 participants. Currently enrolling.

Timeline

15 November 2023

Primary endpoint
1 November 2025

1 November 2025

Quick facts

Lead sponsor	Tiziana Life Sciences LTD
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	54
Start date	15 November 2023
Primary completion	1 November 2025
Estimated completion	1 November 2025
Sites	7 locations across United States

Drugs / interventions tested

• Foralumab — full drug profile →
• Placebo

Conditions studied

• Secondary Progressive Multiple Sclerosis — all drugs for Secondary Progressive Multiple Sclerosis →

Sponsor

Tiziana Life Sciences LTD — full company profile →

Who can join

Adults 18 to 75, any sex, with Secondary Progressive Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The number of patients with adverse event (AE) reports.
  Time frame: Throughout the study, an average of 12 weeks (3 months).
• Changes in the Total Nasal Symptom Score (TNSS).
  Time frame: TNSS is performed during the Screening Visit and during the Treatment Period at the first visit of Cycle 1, Cycle 2, Cycle 3, and Cycle 4 (each Cycle is 3 weeks).
  The TNSS is the sum of scores over 24 hours and 2 weeks for nasal congestion, runny nose, nasal itching, sneezing, and difficulty sleeping. The TNSS is quantified using the following scale: None 0, Mild 1 (symptom clearly present but easily tolerated), Moderate 2 (symptom bothersome but tolerable), Severe 3 (symptom difficult to tolerate - interferes with activities).
• Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment.
  Time frame: Subjects will undergo PET imaging prior to Week 1 (i.e., prior to dosing) and after Week 12 (after Cycle 4 at the PET sub-study site).
  Subjects at all sites will undergo PET imaging with the radiotracer \[18F\]PBR06.

Sponsor's own description

Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases.

The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS).

The primary objectives that this study aims to answer are:

1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo
2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Imaging Outcomes for Phase 2 Trials Targeting Compartmentalized Inflammation.
   Gaitán MI, Marquez RV, Ayerbe J, Reich DS. · · 2024 · cited 1× · PMID 39658905 · DOI 10.1177/13524585241301303
2. Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients With Nonactive Secondary Progressive Multiple Sclerosis
   Chitnis T, Singhal T, Zurawski J, Saraceno T, et al · · 2026
3. The Potential of β-Synuclein-Specific Regulatory T Cell Therapy as a Treatment for Progressive Multiple Sclerosis.
   Osmond GE, John NA, Ting YT, Ooi JD. · · 2025 · PMID 41373685 · DOI 10.3390/ijms262311534
4. Translational molecular imaging and drug development in multiple sclerosis.
   Tay D, Ahmed H, Dawoud A, Salam M, et al · · 2026 · PMID 41356192 · DOI 10.7150/thno.119559