Trials / Recruiting
RecruitingNCT03783416
SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis
Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis: A Phase 1b Randomised, Double-blind, Placebo-controlled Trial.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Queen Mary University of London · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The production of antibodies in the form of oligoclonal bands (OCBs) from plasma cells (cells involved in the body's immune response), is the hallmark of MS. Recent evidence suggests that plasma cells are resident in the meninges (protective membranes of the brain and spinal cord) of people with Multiple Sclerosis (pwMS). Ixazomib is a drug which has been effective in treating multiple myeloma, a disease caused by aberrant plasma cells. The purpose of this study is to investigate whether ixazomib can reduce or clear OCBs from the cerebrospinal fluid (CSF) of pwMS. Participants will be randomly assigned to receive either ixazomib capsules (active drug arm) or placebo capsules (placebo arm) for up to 24 months. Participants with relapsing remitting MS (who are stable on disease modifying therapy) and those with progressive MS (who are not on disease modifying therapy) will be invited to take part in the study.
Conditions
- Relapsing Remitting Multiple Sclerosis
- Primary Progressive Multiple Sclerosis
- Secondary Progressive Multiple Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ixazomib (NINLARO®) capsules / Matching placebo capsules | Participants will be treated for a maximum of 24 months |
Timeline
- Start date
- 2020-06-15
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
- First posted
- 2018-12-21
- Last updated
- 2025-09-04
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03783416. Inclusion in this directory is not an endorsement.