Efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis
- Conditions
- Health Condition 1: G35- Multiple sclerosis
- Registration Number
- CTRI/2020/11/029092
- Lead Sponsor
- Sanofi Healthcare India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
I 01. The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
Type of participant and disease characteristics:
I 02. The participant must have been diagnosed with RRMS according to the 2017 revision of the McDonald diagnostic criteria (16).
03. The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria (11) revised in 2013 (10) and endorsed by an Adjudication Committee.
I 04. The participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee (to evaluate source data for disability confirmation; details see Section 10.1.5.3).
I 05. Absence of clinical relapses for at least 24 months.
I 06. The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
I 07. The participant must have, at screening, disease duration from the onset of MS symptoms
of:
<20 years in participants with EDSS scores at screening >5.0;
OR <10 years in participants with EDSS scores at screening =5.0
Weight
I 05. Not applicable.
Sex
I 06. Male and /or Female
Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A) Male participants
Not applicable
B) Female participants
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a WOCBP
OR
Is a WOCBP and agrees to use an acceptable contraceptive method as described in Appendix 4 of protocol during the intervention period.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) (Appendix 2 [Section 10.2] of protocol) before the first dose of study intervention.
If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Requirements for pregnancy testing during and after study intervention are located in the SoA (Section 1.3 of the protocol).
Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2 (Section 10.2 of the protocol).
The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy, if allowed by local regulations
See Section 10.8 of protocol for country-specific contraception requirements.
Informed Consent
I 10. The participant is capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative (Appendix 1, Section 10.1.3 of the protocol).
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
E 01. The participant has a history of infection or may be at risk for infection:
A history of T-lymphocyte or T-lymphocyte-receptor vaccination, transplantation (including solid organ, stem cell, and bone marrow transplantation) and/or antirejection therapy.
E 02. The presence of psychiatric disturbance or substance abuse as evidenced by:
A history of any psychiatric disease, behavioral condition, or depression requiring hospitalization within 2 years prior to the Screening Visit
E 03. The following findings obtained during the screening visit considered in the Investigator’s judgment to be clinically significant:
Any screening laboratory values outside normal limits.
Abnormal ECG
E 04. Conditions that may predispose the patient to excessive bleeding:
A bleeding disorder or known platelet dysfunction at any time prior to the Screening Visit
E 05. Conditions that would adversely affect participation in the study or make the primary efficacy endpoint non-evaluable:
A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist
Prior/concomitant therapy
E 06. A requirement for concomitant treatment that could bias the primary evaluation, such as any of the following medications/treatments within the specified time frame before any randomization assessment (no wash out is required for interferon beta or glatiramer acetate treatments although use is not permitted on or after Day 1):
Prior/concurrent clinical study experience
E 07. The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes as listed in Section 10.9. of the protocol.
E 08. The participant is receiving anticoagulant/antiplatelet therapies; those that are not permitted to be taken concomitantly with the IMP, include the following:
Acetylsalicylic acid (aspirin)
Antiplatelet drugs (eg, clopidogrel)
E 09. The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
E 10. The participant was previously exposed to any BTK inhibitor, including SAR442168.
E 11. The participant has taken other investigational drugs within 3 months or 5 half-lives, whichever is longer, before the screening visit.
Diagnostic assessments
E 12. The participant has a contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI
Other exclusions
E 13. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
E 14. Any country-related specific regulation that would prevent the participant from entering the study. See Appendix 8 (Section 10.8) (country-specific requirements).
E 15. The participant is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or particip
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method