ClinicaliQ Trial Snapshot
- SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis — Recruiting • Phase I • Neurology • NCT03783416.
- What is being tested: Ixazomib (NINLARO), a proteasome inhibitor licensed for multiple myeloma, is being investigated as a novel therapeutic agent to target plasma cells in multiple sclerosis patients over a 24-month treatment period compared to placebo.
- Patient eligibility overview: The trial recruits MS patients who meet specific inclusion criteria; participants are randomised to receive either ixazomib or placebo capsules, with treatment duration up to 24 months.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : - Each participant must meet all of the following inclusion criteria to be enrolled in the study: 1. Male and female patients 18 to 65 years old at screening 2. Must have a diagnosis of MS, and: * 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 4. OCB positive CSF either from a previous CSF analysis or from the screening CSF analysis 5. Able and willing to give written informed consent and comply with protocol requirements with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 6. Agree to the use of effective contraception as follows: Female patients must: * Be postmenopausal for at least 1 year before the screening visit (postmenopausal status confirmed by serum…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.