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

NCT04411641 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1131

Last updated 2025-07-02

Study results available
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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

Conditions

  • Non-relapsing Secondary Progressive Multiple Sclerosis

Interventions

DRUG

Tolebrutinib

Pharmaceutical form: Film-coated tablet Route of administration: Oral

DRUG

Placebo to match Tolebrutinib

Pharmaceutical form: Film-coated tablet Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2024-08-29
Completion
2024-08-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04411641 on ClinicalTrials.gov