Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (CLASP-MS).

Launched by INSTITUTE OF PSYCHIATRY AND NEUROLOGY, WARSAW · Jul 18, 2023

Keywords

ClinConnect Summary

The CLASP-MS clinical trial is studying a medication called cladribine to see if it can help slow down the progression of non-active secondary progressive multiple sclerosis (MS). MS is a disease that affects the central nervous system and can lead to worsening disability over time. This trial aims to determine if cladribine can reduce inflammation in the brain and prevent brain volume loss. Participants will receive either cladribine or a placebo (a non-active treatment) for six months and will be monitored for two years with regular MRI scans and check-ups.

To be eligible for this trial, participants should be between 30 and 65 years old, have been diagnosed with secondary progressive MS for at least ten years, and have not had any relapses in the past year. They should also meet specific criteria about their level of disability. Those who join the trial can expect to receive treatment and regular follow-up care to assess the effectiveness and safety of the medication. It’s important for potential participants to understand that they will need to commit to using birth control if they are capable of becoming pregnant or fathering a child during the study period. This trial is currently recruiting participants who meet these criteria.

Gender

ALL

Eligibility criteria

• Inclusion 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 contraception method with a failure rate of \<1%
• • Able to fulfill all protocol requirements as judged by the investigator
• Exclusion Criteria:
• • 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 requirements
• • 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 \[an accelerate elimination procedure may be used for teriflunomide instead\]; washout of \> 12 months for ocrelizumab, mitoxantrone, and alemtuzumab)
• • 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 result)
• • 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 g/dL)
• • 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 women; cervical smear in women; prostate-specific antigen in men
• • 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