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

Conditions

• Non-Active Secondary Progressive Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

25 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Foralumab TZLS-401 50 µg — DRUG
  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.

Study Details

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.

Key Dates

Status verified

Mar 2025

Central Contacts

• Tiziana
  1-833-849-4262
  [email protected]
• Keeren Shah
  1-833-849-4262
  [email protected]

Locations (1)

Find similar trials in Boston, MA

Related Studies

• Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
  PHASE2 · Recruiting · Tiziana Life Sciences LTD · Boston, Massachusetts