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

> **NCT04411641** · PHASE3 · COMPLETED · sponsor: **Sanofi** · enrollment: 1131 (actual)

## Conditions studied

- Non-relapsing Secondary Progressive Multiple Sclerosis

## Interventions

- **DRUG:** Tolebrutinib
- **DRUG:** Placebo to match Tolebrutinib

## Key facts

- **NCT ID:** NCT04411641
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-09-24
- **Primary completion:** 2024-08-29
- **Final completion:** 2024-08-29
- **Target enrollment:** 1131 (ACTUAL)
- **Last updated:** 2025-07-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04411641

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04411641, "Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT04411641. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*