Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT03996291|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : January 19, 2021
To determine the long-term safety and tolerability of SAR442168 in RMS participants
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||April 2025|
|Estimated Study Completion Date :||April 2025|
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.
Pharmaceutical form: Film coated tablet Route of administration: Oral
Other Name: SAR442168
- 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)
- 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.
- 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)
- 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
- 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
- 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.
- 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.
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
|Study Director:||Clinical Sciences & Operations||Sanofi|