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

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.

Conditions

• Multiple Sclerosis, Secondary Progressive
• Multiple Sclerosis

Interventions

DRUG

Cladribine Subcutaneous Injection

Cladribine subcutaneous injection, 10 mg daily, for 2-3 consecutive days (depending on individual dose)

DRUG

0.9% Chloride Injection Sodium

0.9% sodium chloride injected subcutaneously, 10 ml daily, for 2-3 consecutive days

Sponsors & Collaborators

• Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

  collaborator OTHER

• Mossakowski Medical Research Centre Polish Academy of Sciences

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• Military Institute of Aviation Medicine

  collaborator OTHER_GOV

• Institute of Psychiatry and Neurology, Warsaw

  lead OTHER

Principal Investigators

• Iwona Kurkowska-Jastrzebska, MD, PhD · Institute for Psychiatry and Neurology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-03

Primary Completion

2027-06-30

Completion

2027-10-30

Countries

• Poland

Study Locations