Dose-finding study in relapsing MS seeks participants

March 29, 2019
Sanofi Genzyme is seeking recruits for a Phase II clinical trial. The purpose of the trial is to assess the safety and effectiveness of the study medication in reducing the number of new active brain lesions reported with MRIs with patients with relapsing MS. Different doses of the study medication will be used to assess which is the most effective dose. The trial will also look at how well the study medication is tolerated and what MS symptoms patients experience during the study.

The study medication belongs to a class of medicines called “Bruton's tyrosine kinase inhibitors,” which can reduce the activity of the BTK enzyme (substance that causes a chemical reaction) in cells from the body's immune system. BTK is an important molecule involved in the development of B cells and microglia (type of immune cells in the brain), which can be involved in the disease process of MS. By reducing the B cells and microglia activation, this may decrease inflammation in the brain. The proposed mechanism of action for the study medication is to prevent the formation of new brain lesions in MS. The study medication will be administered orally (by mouth) as a tablet.

The study will last about 20 weeks, with patients having approximately seven visits to the study center. As the study aims to define the best dose of the study medication, four different doses of the medicine will be tested. Participants will receive 12 weeks of the study medication (one of the four doses) that will be introduced either before or after four weeks of placebo (inactive dummy drug). All participants will be assigned to one of the following two groups:
  • Group 1: Participants will receive one of the four study medication doses for the first 12 weeks, then switch to placebo for four weeks.
  • Group 2: Participants will receive placebo for the first four weeks, then switch to one of the four study medication doses for 12 weeks.

At the end of the study, all participants from this study will be given the option to enroll in a longterm safety follow-up study to assess safety and tolerability of the study medication during a longer period of time. During the study, the participant will undergo assessments such as MRIs to check status of lesions, blood tests to monitor for safety, as well as to measure levels of the study drug, and questionnaires related to symptoms.

Inclusion criteria include:
  • The participant must be between the ages of 18 and 55 years of age and have been diagnosed with relapsing multiple sclerosis.
  • The participant must have at least one documented relapse within the previous year, at least two documented relapses within the previous two years, or at least one active Gd-enhancing brain lesion on an MRI scan in the past six months and prior to screening.

Exclusion criteria include:
  • The participant has been diagnosed with primary-progressive MS or with nonrelapsing secondary-progressive MS.
  • The participant has an EDSS score higher than 5.5 at the first screening visit.
  • The participant has had a relapse in the 30 days prior to randomization.

Patients who participate in this study will sign an Informed Consent and HIPAA form approved by the site’s Institutional Review Board. All personal health information will remain protected and de-identified throughout the length of the study.

To apply to participate in the study, contact Trial Transparency by email (recommended) at Contact-US@sanofi.com, or call 800-633-1610 ext 1 then #.

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