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NCT06292923 · ClinicalTrials.gov registry record · Phase 2
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
A Phase 2 study of Secondary Progressive Multiple Sclerosis, sponsored by Tiziana Life Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 7
- Study locations
NCT06292923 is a Phase 2 study of Secondary Progressive Multiple Sclerosis that is actively recruiting participants, run by Tiziana Life Sciences. The registered enrollment target is 54 participants, below the 490-participant average among 8 other Secondary Progressive Multiple Sclerosis trials with a reported enrollment target (89% lower). The trial reports 7 study locations across 5 states.
The verdict
NCT06292923, a Phase 2 study of Secondary Progressive Multiple Sclerosis, is actively recruiting participants, sponsored by Tiziana Life Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Foralumab
Study Locations (7)
Massachusetts
- Brigham and Women's Hospital - Boston
- University of Massachusetts - Worcester
New York
- University of Buffalo - Buffalo
- Cornell Weill Medical Center - New York
Connecticut
- Yale - North Haven
Maryland
- Johns Hopkins - Baltimore
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2025-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06292923
The ClinicalTrials.gov registry entry for NCT06292923 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 490-participant average among 8 other Secondary Progressive Multiple Sclerosis trials with a reported enrollment target (89% lower). The listed sponsor is Tiziana Life Sciences, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Secondary Progressive Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06292923 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, New York, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06292923 about?
NCT06292923 is a clinical study titled "A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients". 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 s...
What is the current status of trial NCT06292923?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2023-11-15. Estimated completion is 2025-11.
What conditions does trial NCT06292923 study?
This clinical trial studies the following conditions: Secondary Progressive Multiple Sclerosis.
What interventions are being tested in trial NCT06292923?
The interventions under investigation include: Placebo (OTHER), Foralumab (DRUG).
Who is sponsoring clinical trial NCT06292923?
This trial is sponsored by Tiziana Life Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06292923 being conducted?
This trial has 7 study locations across Connecticut, Maryland, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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