Actively Recruiting
Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis A Phase 1b Randomised, Double-blind, Placebo-controlled Trial
Led by Queen Mary University of London · Updated on 2025-09-04
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Q
Queen Mary University of London
Lead Sponsor
T
Takeda Pharmaceuticals International, Inc.
Collaborating Sponsor
AI-Summary
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 drug's safety and its potential impact on MS progression. Participants' health and safety will be closely monitored throughout the study.
CONDITIONS
Brief Title
SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 to 65 years old at screening
- Diagnosis of multiple sclerosis
- Patients with relapsing-remitting MS must be on stable disease modifying therapy without relapse in the last month
- Patients with progressive MS must not be on disease modifying therapy
- Positive oligoclonal bands in cerebrospinal fluid from previous or screening analysis
- Able and willing to give written informed consent and comply with study requirements
- Agree to effective contraception methods as specified for males and females
- Clinical lab values within specified safe limits including neutrophil count, platelet count, bilirubin, liver enzymes, and creatinine clearance
You will not qualify if you...
- Expanded Disability Status Scale (EDSS) greater than 8.5 at screening
- MS relapse within 1 month before screening
- Female patients who are pregnant, lactating, or have positive pregnancy test
- Major surgery within 14 days before baseline
- Clinically relevant malignancy or infection including possible multiple myeloma
- Serious infection or need for intravenous antibiotics within 14 days before enrollment
- Uncontrolled cardiovascular conditions or recent heart events within 6 months
- Recent use of strong CYP3A inducers or St. John's Wort
- History of active hepatitis B or C, HIV positive, or positive Tuberculin test without treatment
- Serious medical or psychiatric illness interfering with study completion
- Gastrointestinal diseases or procedures affecting oral drug absorption
- Malignancy within 2 years before enrollment except certain skin cancers
- Grade 3 or higher peripheral neuropathy or Grade 2 with pain
- Participation in other clinical trials with investigational or licensed drugs within 30 days
- Previous treatment with ixazomib or participation in ixazomib studies
- Known allergy to study medications or their components
- Pre-existing central nervous system disease other than MS
- History of uncontrolled drug or alcohol abuse within 6 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive oral capsules of either ixazomib or placebo following a 28-day cycle, taking capsules on days 1, 8, and 15 followed by one treatment-free week. This treatment continues for up to 24 months.
Monthly visits during treatment cycles
Trial Site Locations
Total: 1 location
1
Royal London Hospital, Barts Health NHS Foundation Trust
London, Greater London, United Kingdom, E1 1BB
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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