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Tests treatment safety and results for Relapsing Remitting Multiple Sclerosis
Official title SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis
ClinicalTrials.gov ID: NCT03783416
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- \- Each participant must meet all of the following to be enrolled in the study:
- Male and female patients 18 to 65 years old at screening
- Must have a diagnosis of MS, and:
- Patients with RRMS must be on DMT
- Patients with progressive MS must not be on DMT
You likely can't join if
- Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
- EDSS \> 8.5 at screening
- MS relapse within 1 month prior to screening
- Female patients who are lactating or have a positive serum pregnancy test at screening
- Major surgery within 14 days before baseline
- Any clinically relevant malignancy or infection, as per CI/PI (or delegate) decision, including a possible diagnosis of multiple myeloma: raised...
See the full eligibility criteria
Who can join
- \- Each participant must meet all of the following to be enrolled in the study:
- Male and female patients 18 to 65 years old at screening
- 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...
- OCB positive CSF either from a previous CSF analysis or from the screening CSF analysis
- 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to give written informed consent and comply with protocol requirements with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- 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 Follicle Stimulating Hormone (FSH) and oestrogen levels at screening or from a historical sample), OR
- Surgically sterile, OR
- If they are of childbearing potential, must agree to practice two effective methods of contraception concurrently from the time of signing the informed consent form until 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not...
- Even if surgically sterilized (post-vasectomy with documentation of azoospermia), agree to practice effective barrier contraception during the entire study treatment period and through to 90 days after the last dose of...
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not...
- Clinical laboratory values:
- Absolute neutrophil count (ANC) ≥ 1 x 109/L
- Platelet count ≥ 100 x 109/L
- Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN)
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3 × ULN.
- Calculated creatinine clearance ≥ 30 mL/min
What rules you out
- Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
- EDSS \> 8.5 at screening
- MS relapse within 1 month prior to screening
- Female patients who are lactating or have a positive serum pregnancy test at screening
- Major surgery within 14 days before baseline
- Any clinically relevant malignancy or infection, as per CI/PI (or delegate) decision, including a possible diagnosis of multiple myeloma: raised erythrocyte sedimentation rate (ESR) and positive urine Bence Jones...
- Infection requiring systemic (intravenous) antibiotic therapy or other serious infection within 14 days before study enrolment. Urinary tract infections (UTIs) will be treated prior to baseline and may delay baseline
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6...
- Systemic treatment, within 14 days before the first dose of ixazomib, with strong Cytochrome P450 Isoform 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St...
- History of active hepatitis B or C virus infection, or human immunodeficiency virus (HIV) positive or positive Tuberculin (TB) ELISPOT. If there is positive TB ELISPOT and the TB team decides to treat as latent TB...
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
- Diagnosed or treated for malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in...
- Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period
- Participation in other clinical trials involving investigational (unlicensed) medicinal products, licensed medicinal products or alternative medicinal therapies, within 30 days of screening and throughout the duration...
- Patients that have previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or placebo
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- Any pre-existing central nervous system disease or involvement other than MS
- History of uncontrolled drug or alcohol abuse within 6 months prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- London, Greater London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Greater London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.