Phase 2
N=125
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03996291 ↗Enrolled (actual)
125
Serious AEs
7.6%
Results posted
Oct 2025
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) — 17; 17; 24; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tolebrutinib (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
17; 17; 24; 20; 26; 29 | — |
| SECONDARY Mean Number of New Gadolinium (Gd)-Enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192 |
0.24; 0.36; 0.32; 0.13 | — |
| SECONDARY Mean Number of New or Enlarging T2 Lesions at Week 240 Relative to Week 192 |
0.32; 0.37; 0.15; 0.24 | — |
| SECONDARY Total Mean Number of Gd-enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192 |
0.24; 0.36; 0.37; 0.13 | — |
| SECONDARY Annualized Relapse Rate (ARR) |
0.26; 0.24; 0.28; 0.23 | — |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 240 |
-0.10; 0.24; 0.38; 0.29 | — |
Summary
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
Eligibility Criteria
Inclusion criteria
- Participants had to have completed treatment in the DRI15928 study
- Female participants had to continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (FSH) level >30 UI/L.
- The participant had to have given written informed consent prior to undertaking any study related procedure.
Exclusion criteria
- The participant had a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
- The participant had 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 had 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 had to be respected except for interferons or glatiramer acetate treatment.
- The participant was receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
- The participant was 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 needed to be stopped at least 5 half-lives before study drug administration except for aspirin, which needed to be stopped at least 8 days beforehand.
- Prior/concurrent clinical study experience. The participant was 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 was pregnant or was a breastfeeding woman.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03996291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.