BridgeMD
Compares treatment options for Multiple Sclerosis, Secondary Progressive
Official title Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (CLASP-MS).
ClinicalTrials.gov ID: NCT05961644
What this study is testing
What is Cladribine Subcutaneous Injection?
Cladribine Subcutaneous Injection is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for multiple sclerosis, secondary progressive.
Also referred to as Cladribine Solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to evaluate the efficacy and safety of subcutaneously administered cladribine versus placebo to stop inflammation and treat disease progression of non-active secondary progressive multiple sclerosis. Multiple sclerosis is an inflammatory disease of the central nervous system.
- Phase 3: a large, late-stage study
- Time commitment: about 122 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65
You may be able to join if
- Written informed consent
- Diagnosis of relapse-onset, secondary progressive multiple sclerosis based on the 2017 McDonald criteria
- Progression of disability over 24 months defined as an increase in the EDSS score of 1 or more for patients with EDSS ≤ 5.5 or of 0.5 or more for...
- Lack of relapses over last 12 months
- EDSS of 3.5 - 7.5 inclusive
You likely can't join if
- Lack of written informed consent
- Previous cladribine treatment
- Hypersensitivity to the investigational medicinal product
- Eligible and willing to use interferon beta, siponimod, or mitoxantrone
- Unable to undergo magnetic resonance imaging
- Pregnancy or breastfeeding
See the full eligibility criteria
- Written informed consent
- Diagnosis of relapse-onset, secondary progressive multiple sclerosis based on the 2017 McDonald criteria
- Progression of disability over 24 months defined as an increase in the EDSS score of 1 or more for patients with EDSS ≤ 5.5 or of 0.5 or more for patients with EDSS \> 5.5
- Lack of relapses over last 12 months
- EDSS of 3.5 - 7.5 inclusive
- Age of 30 - 65 years inclusive
- Duration of MS of 10 years or longer
- Pre-menopausal women must refrain from heterosexual intercourse or use a contraception method with a failure rate of \< 1% from enrolment up to 6 months after the last dose of the investigational medicinal product
- Men must refrain from heterosexual intercourse from enrolment up to 6 months after the last dose of the investigational medicinal product or use a barrier method of contraception, with their female partners using a...
- Able to fulfill all protocol requirements as judged by the investigator
- Lack of written informed consent
- Previous cladribine treatment
- Hypersensitivity to the investigational medicinal product
- Eligible and willing to use interferon beta, siponimod, or mitoxantrone
- Unable to undergo magnetic resonance imaging
- Pregnancy or breastfeeding
- Does not agree to use contraception methods defined above
- Diseases of the nervous system, such as tumors, stroke, traumatic injury, encephalomyelitis, B12 deficiency, or demyelinating diseases other than multiple sclerosis
- Major comorbidities, such as cancer, liver failure, kidney failure, heart failure (NYHA II-III), or any other disease that may jeopardize patient safety or make it impossible for the patient to fulfill protocol...
- Relapse within last 12 months
- Chronic treatment with corticosteroids or immunosuppressants (eg, azathioprine, methotrexate, cyclosporine) within last 6 months
- Disease-modifying treatments for multiple sclerosis (no washout is required for interferons beta, glatiramer acetate, and dimethyl fumarate; washout of \> 6 months for teriflunomide, fingolimod, and natalizumab [an...
- Relapsing-remitting multiple sclerosis
- Primary progressive multiple sclerosis
- Hepatitis B or hepatitis C, including detectable HbsA, anti-HBc, or anti-HCV antibodies in serum
- HIV infection, including a positive screening test (anti-HIV 1/2, protein 24)
- Active or latent tuberculosis, including a positive result of the QuantiFERON TB Gold test during screening or within 3 months (an inconclusive test must be repeated; two inconclusive tests are taken as a positive...
- Other infection that may be worsened by treatment with cladribine
- Lymphopenia (\< 1000/μl), neutrocytopenia (\< 1500/μl), or thrombocytopenia
- Alanine aminotransferase or aspartate aminotransferase \> 2 x ULN (can be repeated when 1.5-3x ULN); Total bilirubin \> 1.5 x ULN (can be repeated when 1.5-3 x ULN); Hemoglobin \> 9.5 g/dL (can be repeated when 9-9.4...
- Lack of vaccination against COVID-19 - the time from the last dose of a full vaccination regimen is shorter than 6 weeks
- Any vaccination within last 6 weeks
- Lack of cancer screening or suspicion of cancer or necessity to carry out additional studies after the following examinations done at screening: chest X-ray in all participants; mammography or breast ultrasound in...
- Patient does not have detectable antibodies against Varicella zoster virus in serum or a proof of two-dose vaccination against this virus (last dose at least 6 months before enrolment)
- Use of oral or parenteral anticoagulants or antiplatelets other than acetylsalicylic acid
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
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 122 weeks 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, 30 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. 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.