Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTiziana Life Sciences LTD
About this trial
Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status.
All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study assessments.
Screening clinical laboratory studies are within the normal ranges or within the parameters specified below, and clinically acceptable in the opinion of the Investigator. Exceptions must be approved by the Clinical Research Organization or Sponsor's Medical Monitor.
Hemoglobin (Hb) ≥ 9 g/dL
Platelets ≥ 100 x 109 cells/L
Disqualifiers
Subjects that terminated TILS-021 early as defined as not undergoing an End of Treatment visit.
Subjects that terminated TILS-021 early as defined as not undergoing an End of Study visit.
Subjects that terminated TILS-021 due to any adverse events.
Corticosteroid use (oral or intravenous) within the last 60 days or anticipated need for such treatment during the study period.
Trial design
Design model
Single group
Treatments tested in this trial
Foralumab TZLS-401 100 µg
DrugPatients meeting the requirements of the dose escalation rules will receive nasal foralumab 100 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Nasal foralumab 50 μg per dosing day (25 μg per nostril)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability
The safety and tolerability of 50 µg/dose and 100 µg/doses of foralumab nasal as measured by adverse event reports
Time frame
Day 1 vs Day 169 (end of study)2
Change in Baseline
Assess change in baseline Modified Fatigue Impact Scale (MFIS) Scores range from 0-84. 0 is the minimum score and 84 is the maximum score. Lower scores indicate less fatigue while higher scores indicate increased fatigue.
Time frame
Day 1 vs Day 169 (or termination)3
Safety and Tolerability
Blood pressure will be monitored at the beginning of every cycle. Increases and decreases in baseline will be monitored assessed for safety.
Time frame
Day 1 vs Day 169 (or termination)4
Safety and Tolerability
Heart rate will be monitored at the beginning of every cycle. Increases and decreases in baseline will be monitored assessed for safety.
Time frame
Day 1 vs Day 169 (or termination)]Secondary outcomes
1
Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue
Assess change in baseline PROMIS Fatigue Short Form 7a. Scores range from 0-35 where the lower number indicated less fatigue.
Time frame
Day 1 of study vs End of Study (Day 169) or Early Termination2
Baseline Neurostatus Expanded Disability Status Scale (EDSS)
Assess change in baseline Neurostatus EDSS. Scores range from 0-10 where the lower number indicates less disability.
Time frame
Day 1 of study vs End of Study (Day 169) or Early Termination.3
Baseline Multiple Sclerosis Functional Composite (MSFC-4)
Assess change in baseline Multiple Sclerosis functional composite (MSFC-4)
Time frame
Day 1 of study vs End of Study (Day 169) or Early TerminationSponsors and contacts
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Source ClinicalTrials.gov