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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,131 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04411641
The ClinicalTrials.gov registry entry for NCT04411641 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tolebrutinib is the first listed.
NCT04411641 reports 0 study locations.
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.
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