Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168

STATUS

Recruiting
participants needed

900
sponsor

Sanofi

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Updated on 19 February 2024

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serum pregnancy test

urine test

multiple sclerosis

contraceptive use

pregnancy test urine

brain lesion

teriflunomide

aubagio

Summary

Primary Objective:

To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS

Secondary Objective:

To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study will be offered to participate in a long term safety study.

Details

Condition	Relapsing Multiple Sclerosis
Age	18years - 55years
Treatment	SAR442168, Placebo to match SAR442168, Teriflunomide HMR1726, Placebo to match Teriflunomide
Clinical Study Identifier	NCT04410978
Sponsor	Sanofi
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
	The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
	The participant has an expanded disability status scale (EDSS) score 5.5 at the first Screening Visit
	The participant must have at least 1 of the following prior to screening
	documented relapse within the previous year OR
	documented relapses within the previous 2 years, OR
	documented Gd enhancing brain lesion on an MRI scan within the previous year
	Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
	Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure
	Refrain from donating sperm
	Plus either
	Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
	Must agree to use contraception/barrier as detailed below
	Agree to use a male condom and should also be advised of the benefit for a
	female partner to use a highly effective method of contraception as a condom
	may break or leak when having sexual intercourse with a woman of childbearing
	potential (WOCBP) who is not currently pregnant
	A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions apply
	Is not a WOCBP OR
	Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and until accelerated elimination procedure is completed (or for at least 10 days after the last dose of SAR442168, if the case was unblinded) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for the same period of time
	A WOCBP must have a negative highly sensitive pregnancy test urine or serum, as required by local regulations) within the screening period 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
	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
	The participant must have given written informed consent prior to undertaking any study related procedure. This includes consent to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of maturity is greater than 18 years, a specific ICF for such legally minor participants must also be signed by the participant's legally authorized representative
Exclusion Criteria
	The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiple sclerosis (SPMS)
	The participant has conditions or situations that would adversely affect participation in this study, including but not limited to
	A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist
	Medical condition(s) or concomitant disease(s) making them nonevaluable for the primary efficacy endpoint or that would adversely affect participation in this study, as judged by the Investigator
	A requirement for concomitant treatment that could bias the primary evaluation
	The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study
	At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody
	The participant has any of the following
	A bleeding disorder or known platelet dysfunction at any time prior to the screening visit
	A platelet count <150 000/L at the screening visit
	The participant has a lymphocyte count below the lower limit of normal (LLN) at the screening visit
	The presence of psychiatric disturbance or substance abuse
	Prior/concomitant therapy
	The participant is receiving strong inducers or inhibitors of cytochrome P450 (CYP) 3A or CYP2C8 hepatic enzymes as listed in Appendix 8A (Section 10.8)
	The participant is receiving anticoagulant/antiplatelet therapies
	The above information is not intended to contain all considerations relevant
	to a patient's potential participation in a clinical trial

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Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168