The study seeks to investigate safety and efficacy of ixazomib (NINLARO), a proteasome inhibitor, in multiple sclerosis (MS). Participants will receive either ixazomib capsules or placebo capsules for up to 24 months.
Male and female patients 18 to 65 years old at screening
Patients with RRMS must be on DMT
Patients with progressive MS must not be on DMT
Participants with RRMS must be on stable DMT (i.e. must not have had a relapse within 1 month prior to the screening visit). Patients on tecfidera, cladribine, ocrelizumab, alemtuzumab, fingolimod or natalizumab must be enrolled with caution, at Chief Investigator's (CI) discretion because of the lymphopenia caused by these drugs and the risk of thrombocytopenia in 1-2 % of people after alemtuzumab
EDSS > 8.5 at screening
MS relapse within 1 month prior to screening
Female patients who are lactating or have a positive serum pregnancy test at screening
Major surgery within 14 days before baseline
Queen Mary University of London
Lead sponsor
Takeda Pharmaceuticals International, Inc.
Collaborator