Safety and Effectiveness of Ixazomib Capsules Compared to Placebo in Adults with Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ixazomib NINLARO, a drug that targets plasma cells, in people with multiple sclerosis MS. The study focuses on whether ixazomib can reduce or eliminate oligoclonal bands OCBs of antibodies found in the cerebrospinal fluid of individuals with MS. This phase 1b trial includes participants with relapsing-remitting MS who are stable on disease-modifying therapy and those with progressive MS not currently on such therapy. Participants will be randomly assigned to receive either ixazomib capsules or placebo capsules over a period of up to 24 months. Treatment follows a 28-day cycle with capsules taken orally on days 1, 8, and 15, followed by one week without treatment. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the trial, participants will undergo regular assessments including monitoring for adverse events and measuring the presence of OCB IgG antibodies in cerebrospinal fluid. Magnetic resonance imaging MRI scans and disability status evaluations using the Expanded Disability Status Scale EDSS will also be conducted at baseline and throughout the 24 months. These assessments help researchers understand the drugs safety and its potential impact on MS progression. Participants health and safety will be closely monitored throughout the study.

SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis