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RECRUITING Phase 2

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

NCT06292923 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 54 participants
Start Date 2023-11-15
Est. Completion 2025-11
Phase Phase 2

Sponsor

Tiziana Life Sciences

3 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tiziana Life Sciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06292923 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Massachusetts, New York, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06292923?

The interventions under investigation include: Placebo (OTHER), Foralumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06292923?

This trial is sponsored by Tiziana Life Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial