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NCT04411641 · ClinicalTrials.gov registry record · Phase 3
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,131
- Enrollment target
NCT04411641: Completed Phase 3 study, sponsored by Sanofi.
NCT04411641 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,131 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04411641, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,131 participants
- Enrollment target
Study 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
Primary Outcome
The EDSS is a disability scale that assesses the following 7 functional domains: visual, brainstem, pyramidal \[motor\], cerebellar \[coordination\], sensory, cerebral, and bowel/bladder. The total EDSS ranges from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]) (0.5 increments from 1-10; next increase after 0 is 1). Higher scores indicated increased disability. Time to onset of 6-month CDP was defined as the time from randomization to the onset of a sustained increase from baseline in
Interventions
- DRUG Tolebrutinib
- DRUG Placebo to match Tolebrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,131 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2024-08-29 |
| Phase | Phase 3 |
What the finished NCT04411641 record still lists
NCT04411641 is an interventional study that assigns participants to a tested intervention. Its 1,131 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Tolebrutinib is the first listed.
NCT04411641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04411641 about?
NCT04411641 is a clinical study titled "Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)". 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 fu...
What is the current status of trial NCT04411641?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,131 participants. The study started on 2020-09-24. Estimated completion is 2024-08-29.
What interventions are being tested in trial NCT04411641?
The interventions under investigation include: Tolebrutinib (DRUG), Placebo to match Tolebrutinib (DRUG).
Who is sponsoring clinical trial NCT04411641?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04411641's enrollment target sits among peer trials
1,131 245th of 2000 higher than 1,755 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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