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Gemini 1


Title A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis
Therapeutic Area Multiple Sclerosis
Principal Investigator Kristen Babinski, MD, PhD
Min Age 18 Years
Max Age 55 Years
Gender All
Contact Pradnya Ghule
617-636-7620
pghule@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04410978

Overview

The purpose of the study is to assess the efficacy and safety of SAR442168 compared with teriflunomide (Aubagio) in participants with relapsing multiple sclerosis (RMS).

The experimental drug works in the blood and in the brain where it blocks a molecule called “Bruton's tyrosine kinase (BTK)”, which is present in some cells involved in multiple sclerosis (immune cells known as B-cells and microglial cells). This mechanism of action may help stop the formation of new brain lesions in MS.

Study Details

Inclusion Criteria

  • The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria (16).
  • The participant has an EDSS score ≤5.5 at the first Screening Visit
  • The participant must have at least 1 of the following prior to screening:
    • ≥1 documented relapse within the previous year OR
    • ≥2 documented relapses within the previous 2 years, OR
    • ≥1 documented Gd-enhancing brain lesion on an MRI scan within the previous year.

Exclusion Criteria

  • The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria (16) or with nonrelapsing SPMS (17).
  • The participant has a history of infection or may be at risk for infection:
  • A history of T-lymphocyte or T-lymphocyte-receptor vaccination, transplantation (including solid organ, stem cell, and bone marrow transplantation) and/or antirejection
  • therapy.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

Study Requirements

We expect you to be in study for 18-36 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.