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Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients

NCT06802328 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-06-06

No results posted yet for this study

Summary

This is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.

Conditions

  • Non-Active Secondary Progressive Multiple Sclerosis

Interventions

DRUG

Foralumab TZLS-401 50 µg

Foralumab 50 µg/dosing day for patients who have failed current therapies. Patients will be dosed in 3-week cycles, with foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". Patients will receive Day 1 doses of nasal foralumab under supervision at the Center for Clinical Investigation at BWH.

Sponsors & Collaborators

  • Tiziana Life Sciences LTD

    lead INDUSTRY

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06802328 on ClinicalTrials.gov