Safety and Efficacy of Subcutaneous Cladribine for Nonrelapsing, Secondary Progressive Multiple Sclerosis (CLASP-MS): a Randomized, Placebo-controlled, Double-blind, Phase 2 Study.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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. In most patients, it starts with a relapsing course (RMS) which is caused by acute inflammatory lesions in the brain and spinal cord. RMS transforms at later stages into progressive disease (secondary progressive MS). Currently approved disease-modifying treatments are effective in reducing clinical relapses and brain and spinal lesions visible in MR, but they perform poorly in preventing disease progression and overall disability accumulation. The growing evidence shows that disease progression partially depends on chronic inflammation present in the CNS. Drugs, which may cross the blood-brain barrier and reach inflammatory cells residing in the CNS might be effective in this stage of the disease. Cladribine is one of the DMT approved for RMS. It is a synthetic purine analog with selective lymphocyte toxicity, which enter the CNS and is found in cerebrospinal fluid. In patients treated with cladribine, the oligoclonal bands tend to disappear proving that neuroinflammation is diminished. The participants of this clinical trial with the later non-active stage of MS are enrolled to be treated with cladribine subcutaneously or a non-active comparator (placebo) for 6 months and followed for the next 2 years, with an MRI scan and clinical evaluation every 6 months. The main questions it aims to answer are if in the non-active stage of MS cladribine is potent to lessen brain volume loss and if it is potent to attenuate inflammation in the CNS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Institute of Psychiatry and Neurology
RECRUITING
Warsaw
Contact Information
Primary
Iwona Kurkowska-Jastrzebska, MD, PhD
ikurkowska@ipin.edu.pl
+48-4582800
Backup
Łukasz Smolinski, MD, PhD
lsmolinski@ipin.edu.pl
+48-4582800
Time Frame
Start Date: 2022-10-03
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 188
Treatments
Experimental: Experimental
Drug: Cladribine at a dose of 1.8 mg/kg of body weight. Cladribine will be given subcutaneously over 6 visits every 5-6 weeks.
Placebo_comparator: Control
Comparator: Placebo matched to the subcutaneous injection of cladribine.
Related Therapeutic Areas
Sponsors
Leads: Institute of Psychiatry and Neurology, Warsaw
Collaborators: Military Institute of Aviation Medicine, Poznan University of Medical Sciences, Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences, Mossakowski Medical Research Centre Polish Academy of Sciences

This content was sourced from clinicaltrials.gov