Actively Recruiting
SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis
Led by Queen Mary University of London · Updated on 2025-09-04
72
Participants Needed
1
Research Sites
319 weeks
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
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.
CONDITIONS
Official 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 within 1 month before screening
- 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 provide written informed consent and comply with study requirements
- Agree to use effective contraception as specified: females must be postmenopausal, surgically sterile, or use two effective contraception methods; males must use effective barrier contraception or abstain according to lifestyle
- Clinical laboratory values within specified limits: absolute neutrophil count ≥ 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, total bilirubin ≤ 1.5 times upper normal limit, ALT and/or AST ≤ 3 times upper normal limit, creatinine clearance ≥ 30 mL/min
You will not qualify if you...
- Expanded Disability Status Scale (EDSS) score greater than 8.5 at screening
- Multiple sclerosis relapse within 1 month before screening
- Female patients who are lactating or have a positive pregnancy test at screening
- Major surgery within 14 days before baseline
- Any clinically relevant malignancy or infection, including possible multiple myeloma
- Infection requiring intravenous antibiotics or serious infection within 14 days before enrollment
- Uncontrolled cardiovascular conditions including hypertension, arrhythmias, heart failure, unstable angina, or recent heart attack within 6 months
- Use of strong CYP3A inducers or St. John's Wort within 14 days before first dose
- History of active hepatitis B or C, HIV positive, or positive Tuberculin test unless treated for latent TB
- Serious medical or psychiatric illness interfering with study completion
- Known gastrointestinal disease or procedures affecting oral drug absorption
- Malignancy diagnosis or treatment within 2 years before enrollment except fully resected non-melanoma skin cancer
- Peripheral neuropathy grade ≥ 3 or grade 2 with pain during screening
- Participation in other clinical trials with investigational or licensed medicinal products within 30 days before screening
- Previous treatment with ixazomib or participation in ixazomib studies
- 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
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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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