Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age25-75
SponsorTiziana Life Sciences LTD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of MS (according to the 2010 McDonald criteria).
Age 25-75 years old.
Clinical diagnosis of non-active SPMS, as defined by the absence of relapses for 2 years.
MRI imaging consistent with a diagnosis of MS at any time point.
Disqualifiers
Need for corticosteroid treatment (oral or intravenous) within the past 30 days or anticipated need within 30 days of foralumab therapy initiation.
Treatment with Ocrevus® (ocrelizumab), Rituxun® (rituximab), Kesimpta® (ofatumumab), Truxima® (rituximab-abbs) within the past 90 days.
Treatment with Lemtrada® (alemtuzumab) and Mavenclad® (cladribine) within the past 1 year.
Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate or natalizumab within the past 90 days.
Trial design
Treatments tested in this trial
Foralumab TZLS-401 50 µg
DrugForalumab 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.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov