Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Sanofi

Status and phase: Active, not recruiting; Phase 2

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Tolebrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03996291

2018-004731-76

LTS16004

U1111-1223-4256 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Full description

Approximately 62 months including the 8 weeks post-treatment visit

Enrollment: 125 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have completed treatment in the DRI15928 study
• Female participants must continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. Menopause is defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (FSH) level >30 UI/L.
• The participant must have given written informed consent prior to undertaking any study related procedure.

Exclusion criteria

• The participant has a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.

• The participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study.

• The participant has received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing treatment with SAR442168. Washout periods after treatment with non-study DMTs should be respected except for interferons or glatiramer acetate treatment.

• The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.

• The participant is receiving anticoagulant/antiplatelet therapies, including:

  • Acetylsalicylic acid (aspirin)
  • Antiplatelet drugs (eg, clopidogrel)
  • Warfarin (vitamin K antagonist)
  • Heparin, including low molecular weight heparin (antithrombin agents)
  • Dabigatran (direct thrombin inhibitor)
  • Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)

Note: All above drugs need to be stopped at least 5 half-lives before study drug administration except for aspirin, which needs to be stopped at least 8 days beforehand.

• Prior/concurrent clinical study experience. The participant is taking part in another interventional clinical trial of another drug substance.
• Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures
• The participant is pregnant or is a breastfeeding woman.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

SAR442168

Experimental group

Description:

SAR442168 : Experimental - Part A: Double-blind period of continued treatment with the respective SAR442168 dose administered in the DRI15928 study until selection of Phase 3 dose. Part B: Open-label period of a single-group treatment with SAR442168 selected Phase 3 dose of 60 mg. All participants will be switched to this 60 mg dose.

Treatment:

Drug: Tolebrutinib