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
Qualifiers
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
Treatments tested in this trial
- Foralumab TZLS-401 100 µg
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov