A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis.
- Conditions
- demyelinating diseaseMultiple sclerosis10012303
- Registration Number
- NL-OMON53998
- Lead Sponsor
- Sanofi B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1
*18 to 55 year old male or female with RMS
*EDSS score of <= 5.5 points at screening
*At least 1 of the following prior to screening:
- >=1 documented relapse within the previous year OR
- >=2 documented relapses within the previous 2 years, OR
- >=1 documented Gd-enhancing brain lesion on an MRI scan within the previous
year.
*Without:
-PPMS diagnosis
-Significant infection/at increased infection risk
-Significant psychiatric disease or substance abuse
-Excess bleeding risk or use of antiplatelets/anticoagulants
-Recent use of MS treatments
-Significant other concomitant illness/short life expectancy
*If female of childbearing potential:
--not pregnant or breastfeeding, and agrees to use acceptable contraceptive
method during the intervention period (at a minimum until after the last IMP
dose)
Note. The initial clinical demyelinating episode of MS should be counted as a
relapse for the
first 2 criteria.
-Diagnose of PPMS
-History of infection or at risk for infection
-Presence of psychiatric disturbance or substance abuse
-Confirmed laboratory or ECG abnormalities, during the screening visit, deemed
by the investigator to be clinically significant.
-Conditions that may predispose the participant to excessive bleeding
-Conditions that would adversely affect participation in study or make primary
efficacy endpoint non-evaluable
-Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or
CYP2C8 hepatic enzymes
-Receiving anticoagulant/antiplatelet therapies
-Sensitivity to study interventions, or drug or other allergy that, per
Investigator, contraindicates participation in the study.
-Previously exposed to any BTK inhibitor, including SAR442168.
-Taken other investigational drugs within 3 months or 5 half-lives, whichever
is longer, before SCR.
-A relapse in the 30 days prior to randomization
-Contraindication for MRI (People with contraindication to gadolinium (Gd) can
be enrolled but cannot receive Gd during MRI scan.)
-Institutionalized because of regulatory or legal order; prisoners or
participants who are legally institutionalized.
-Any country-related regulation that would prevent entering the study, if
applicable.
-Not suitable for participation, whatever the reason, as judged by
Investigator, including medical or clinical conditions, or participants
potentially at risk of noncompliance to study procedures or not able to follow
protocol assessments
-Dependent on Sponsor or Investigator
-Employees of study site or directly involved in conduct of study, or immediate
family members of such individuals.
-Any other situation during study course that may raise ethics considerations.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the time to onset of CDP (confirmed for at<br /><br>least 6 months) assessed by the annualized adjudicated relapse rate(AARR).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints from time to event will be analysed in a similar manner<br /><br>to the primary efficacy endpoint.<br /><br>• Time to start of composite CDP<br /><br>• Time to start of 3 months CDP<br /><br>• Time to CDI<br /><br>• Total number of new and / or growing hyperintense T2 lesions using MRI<br /><br>• Percentage change in brain volume loss using MRI<br /><br>• Change in cognitive function using the SDMT<br /><br>• Change in the score on the *quality of life* questionnaire<br /><br>• Adverse reactions (Aes), serious adverse events (SAEs), safety results on<br /><br>MRI, and possible clinically significant abnormalities in laboratory results,<br /><br>on electrocardiogram (ECG) or in vital signs during the study period.</p><br>