A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis (HERCULES)

STATUS

Recruiting
End date

Aug 23, 2024
participants needed

1290
sponsor

Sanofi

Send

Updated on 23 October 2022

See if I qualify

contraceptive use

disease or disorder

chronic progressive multiple sclerosis

secondary progressive multiple sclerosis

Summary

Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS

Secondary Objective:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS 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 24 to 48 months.

Participants completing the treatment period will be proposed to enroll in a separate long term safety study.

Details

Condition	Secondary Progressive Multiple Sclerosis
Treatment	SAR442168, Placebo to match SAR442168, Tolebrutinib, Placebo to match Tolebrutinib
Clinical Study Identifier	NCT04411641
Sponsor	Sanofi
Last Modified on	23 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	to 60 years of age inclusive
	Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria
	Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at screening
	The participant must have documented evidence of disability progression observed during the 12 months before screening
	Absence of clinical relapses for at least 24 months
	Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
	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
Exclusion Criteria
	Evidence of infection with human immuodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections that would adversely affect study participation
	The participant has conditions that would adversely affect study participation such as short life expectancy
	Persistent chronic or active or recurring system infection, that may adversely affect participation or IMP administration in this study, as judged by the Investigator
	History of organ transplant
	History of malignancy within 5 years prior to screening
	History of alcohol or drug abuse within 1 year prior to screening
	Hospitalized for psychiatric disease within 2 years prior to screening
	Bleeding disorder, known platelet dysfunctionat any time prior to the screening visit
	Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at screening
	A platelet count <150 000/μL at the screening visit
	A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal bleeding
	Lymphocyte count below the lower limit of normal at screening
	Recent live (attenuated) vaccine within 2 months before the first treatment visit
	Recent major surgery (within 4 weeks of screening) or planned major surgery during the study
	The participant has received medications/treatments for MS within a specified time frame
	Receiving potent and moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes
	Receiving anticoagulant or antiplatelet therapy (such as aspirin>81mg/day, clopidogrel, warfarin)
	Contraindications to magnetic resonance imaging (MRI)
	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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Step 3 Enroll in the clinical study

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Study Definition

Wikipedia

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis (HERCULES)