Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-relapsing Secondary Progressive Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT04411641

Run by

Sanofi

People needed

1131

Starts

2020-09-24

Expected to finish

2024-08-29

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 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

You may not qualify if…

• The participant has conditions that would adversely affect study participation such as short life expectancy.
• 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.
• 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 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.
• Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at screening
• Bleeding disorder, known platelet dysfunctionat any time prior to the screening visit
• 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.

Where it is running

• Center for Neurology and Spine-Site Number:8400089 — Phoenix, Arizona, United States
• Arcadia Neurology Center-Site Number:8400070 — Arcadia, California, United States
• UC San Diego ACTRI-Site Number:8400101 — La Jolla, California, United States
• Collaborative Neuroscience Research-Site Number:8400045 — Long Beach, California, United States
• Multiple Sclerosis Center-Site Number:8400143 — Los Angeles, California, United States
• University of San Francisco, Sandler Neurosciences Center-Site Number:8400137 — San Francisco, California, United States
• Harbor UCLA-Site Number:8400088 — Torrance, California, United States
• Regina Berkovich, MD, PhD-Site Number:8400059 — West Hollywood, California, United States
• Mountain Neurological Research Center, Inc.-Site Number:8400128 — Basalt, Colorado, United States
• University of Colorado-Site Number:8400012 — Denver, Colorado, United States
• Advanced Neurosciences Research-Site Number:8400025 — Fort Collins, Colorado, United States
• South Florida Neurology Associates-Site Number:8400029 — Boca Raton, Florida, United States
• Neurology Associates, PA-Site Number:8400004 — Maitland, Florida, United States
• Aqualane Clinical Research-Site Number:8400027 — Naples, Florida, United States
• Axiom Clinical Research of Florida-Site Number:8400001 — Tampa, Florida, United States
• University of South Florida-Site Number:8400006 — Tampa, Florida, United States
• Meridian Clinical Research-Site Number:8400003 — Savannah, Georgia, United States
• Consultants In Neurology-Site Number:8400011 — Northbrook, Illinois, United States
• University of Kansas Medical Center-Site Number:8400023 — Kansas City, Kansas, United States
• CHI Saint Joseph Medical Group Neurology-Site Number:8400110 — Lexington, Kentucky, United States
• Tufts Medical Center-Site Number:8400072 — Boston, Massachusetts, United States
• University of Massachusetts-Site Number:8400014 — Worcester, Massachusetts, United States
• Wayne State University-Site Number:8400046 — Detroit, Michigan, United States
• The Memorial Hospital-Site Number:8400033 — Owosso, Michigan, United States
• University of Alabama MS Center-Site Number:8400013 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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