NCT04411641

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,131 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

This was an event-driven (6-month CDP) trial with a variable treatment duration (end-of-study \[EOS\] duration: up to approximately 47months). Participants with 6-month confirmed disability progression (CDP) had an option to receive tolebrutinib in the open-label (OL).

Conditions

• Non-relapsing Secondary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-24
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2020-06-02
• Last updated: 2025-07-02
• Results posted: 2025-06-18

Locations

306 sites across 31 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

Regulatory

• FDA-regulated drug study