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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996291
Recruitment Status : Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : April 24, 2023
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief 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


Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: Tolebrutinib Phase 2

Detailed Description:
Approximately 62 months including the 8 weeks post-treatment visit
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : November 29, 2024
Estimated Study Completion Date : November 29, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SAR442168

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.

 Drug: Tolebrutinib
Pharmaceutical form: Film coated tablet Route of administration: Oral
Other Name: SAR442168


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks) ]
    Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  2. Number of Participants with Potentially Clinically Significant Abnormalities [ Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks) ]
    Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs during the study period.


Secondary Outcome Measures :
  1. Number of new gadolinium (Gd)-enhancing T1 hyperintense lesions [ Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks) ]
    New gadolinium (Gd)-enhancing T1 hyperintense lesions determined by brain Magnetic Resonance Imaging (MRI)

  2. Number of new or enlarging T2 lesions [ Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks) ]
    T2 lesions, a marker of inflammatory activity and brain tissue destruction in RMS will be evaluated by MRI

  3. Total number of Gd-enhancing T1-hyperintense lesions [ Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks) ]
    Total number of Gd-enhancing T1-hyperintense lesions

  4. Number of participants wih relapse (Annualized Relapse rate) [ Time Frame: Baseline to Month 60 ]
    Annualized Relapse rate is defined as the number of participants with relapse during the study period.

  5. Change in Expanded Disability Status Scale (EDSS) from baseline over time [ Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks) ]
    Standard EDSS assessments of neurological symptoms in each of 7 functional domains (visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral and bowel/bladder) will be performed. Ambulation will also be scored as part of the evaluation.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996291


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03996291    
Other Study ID Numbers: LTS16004
2018-004731-76
U1111-1223-4256 ( Other Identifier: UTN )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases