Trials Sponsored by: Sanofi

Which Patients Qualify?

There are four different studies being conducted.

 

Gemini I and Gemini II (RMS)

Active control studies comparing tolebrutinib, the investigational study drug, to Aubagio® (teriflunomide) in patients with relapsing forms of multiple sclerosis (RMS). Testing the effect of the investigational drug on annualized relapse rate, disability progression, magnetic resonance imaging (MRI) lesions, the ability to learn and process information, and quality of life.

Key Inclusion

  • Patients with Relapsing Multiple Sclerosis (RMS)
  • Ages 18 to 55 years
  • EDSS ≤ 5.5

Key exclusion criteria:

  • Washout is required for patients currently taking ocrelizumab, teriflunomide, natalizumab, alemtuzumab, anticoagulants /antiplatelets (different washout periods are required for the DMTs).
  • Patients diagnosed with cancer in the past 5 years, HIV, Hepatitis B or C, or class 3 or 4 heart failure, active/latent TB
  • Patients hospitalized for any psychiatric condition in past 2 years
  • Pregnant women or women planning to become pregnant in few years

Hercules (nrSPMS)

Placebo-control study comparing tolebrutinib, the investigational study drug, to placebo in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Testing the effect of the investigational drug on disability progression, magnetic resonance imaging (MRI) lesions, the ability to learn and process information, and quality of life.

Key Inclusion

  • Patients with Non-Relapsing Secondary Progressive Multiple Sclerosis (nrSPMS)
  • Ages 18 to 60 years
  • No relapses in past 24 months
  • EDSS of 2 to 6.5

Key Exclusion criteria:

  • Washout is required for patients currently taking ocrelizumab, teriflunomide, natalizumab, alemtuzumab, anticoagulants/antiplatelets (different washout periods are required for the DMTs).
  • Patients diagnosed with cancer in the past 5 years, HIV, Hepatitis B or C, or class 3 or 4 heart failure, active/latent TB
  • Patients hospitalized for any psychiatric condition in the past 2 years
  • Pregnant women or women planning to become pregnant in the next 4 years

Perseus (PPMS)

Placebo-control study comparing tolebrutinib, the investigational study drug, to placebo in patients with primary progressive multiple sclerosis (PPMS). Testing the effect of the investigational drug on disability progression, magnetic resonance imaging (MRI) lesions, the ability to learn and process information, and quality of life.

Key Inclusion:

  • Patients with Primary Progressive Multiple Sclerosis (PPMS)
  • Ages 18 to 55 years
  • EDSS of 2 to 6.5

Key Exclusion criteria:

  • Washout is required for patients currently taking ocrelizumab, teriflunomide, natalizumab, alemtuzumab, anticoagulants/antiplatelets (different washout periods are required for the DMTs).
  • Patients diagnosed with cancer in the past 5 years, HIV, Hepatitis B or C, or class 3 or 4 heart failure, acute/latent tuberculosis (TB)
  • Patients hospitalized for any psychiatric condition in the past 2 years
  • Pregnant women or women planning to become pregnant in the next 4 years

Learn More about the MS Clinical Trials (Healthcare Professionals Only)

If you are a qualified healthcare professional (HCP) and interested in learning more about the MS Clinical Trials, including if your patient(s) may qualify to participate, please fill out the brief form below and a qualified healthcare professional or other study team member will be in contact with you shortly:

Submit Your Patient’s Contact Information (Optional):

Thank you for completing the questionnaire.

If you are referring a patient 18 years or older, please provide their (or their parent/legal guardian’s) contact information in the form below (trials do not accept any patients less than 18 years old).

A nurse from the study team will contact your patient (or parent/legal guardian) to review eligibility and discuss the appropriate MS trial(s).

By checking the box below, I understand that the personal information I have provided may be collected, shared, used and/or transferred to the MS clinical trials study team and their representatives for the sole purpose of enabling me or the contact person to be contacted regarding a clinical trial.

By checking this box, I verify that:

  • The name and phone number I have provided belong to my patient or their parent or legal guardian, are correct, and I attest that the contact person is interested in being contacted regarding a clinical trial (in order to help prevent unauthorized use of this service).
  • I confirm that I have read and understood the Privacy Policy
  • The contact person is 18 years or older.
  • My patient or their contact person has agreed to be contacted via phone by study team representatives

By clicking submit, I understand that the personal information I have provided may be collected, shared, used and/or transferred to the MS clinical trials study team and their representatives for the sole purpose of enabling me or the contact person to be contacted regarding a clinical trial.

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