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Hercules


Title A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis
Therapeutic Area Multiple Sclerosis
Principal Investigator Kristen Babinski, MD, PhD
Min Age 18 Years
Max Age 60 Years
Gender All
Contact Pradnya Ghule
617-636-7620
More Information https://clinicaltrials.gov/ct2/show/NCT04411641

Overview

The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with NRSPMS compared to placebo and has an acceptable safety profile.

Study Details

Inclusion Criteria

  • The participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria
  • The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 and endorsed by an Adjudication Committee.
  • The participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.

Exclusion Criteria

  • The participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before the first treatment visit.
  • The participant has a lymphocyte count less than the lower limit of normal (LLN) at the Screening Visit.
  • A history of diagnosis of progressive multifocal leukoencephalopathy (PML) or evidence of findings suggestive of PML on the screening MRI.

Study Requirements

We expect you to be in study for 24-48 months. The study visits would be monthly for first 6 months, after that the visits would be alternate month upto one year followed by quarterly visits. The investigational drug is an orally administered, small molecule. Blood sample would be collected every visit. Questionnaires and rater scales would be collected every visit. MRI would be performed every 3 months until the study ends.