Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04458051 · ClinicalTrials.gov registry record · Phase 3
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
A Phase 3 study of Primary Progressive Multiple Sclerosis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 767
- Enrollment target
- 20
- Study locations
NCT04458051 is a Phase 3 study of Primary Progressive Multiple Sclerosis that has completed, run by Sanofi. The registered enrollment target is 767 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT04458051, a Phase 3 study of Primary Progressive Multiple Sclerosis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 767 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: 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 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tolebrutinib
Study Locations (20)
California
- UC San Diego ACTRI Site Number : 8400101 - La Jolla
- Collaborative Neuroscience Research Site Number : 8400045 - Los Alamitos
- Multiple Sclerosis Center- Site Number : 8400143 - Los Angeles
- Multiple Sclerosis Center of California Site Number : 8400135 - Newport Beach
- SC3 Research - Pasadena Site Number : 8400070 - Pasadena
- University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137 - San Francisco
- Harbor UCLA Site Number : 8400088 - Torrance
- Regina Berkovich, MD, PhD Site Number : 8400059 - West Hollywood
Florida
- South Florida Neurology Associates Site Number : 8400029 - Boca Raton
- MS & Neuromuscular Center of Excellence Site Number : 8400172 - Clearwater
- University of Florida, Fixel Center for Neurology Site Number : 8400159 - Gainesville
- Neurology Associates, PA- Site Number : 8400004 - Maitland
- University of South Florida Site Number : 8400006 - Tampa
Colorado
- Advanced Neurosciences Research Site Number : 8400025 - Fort Collins
Georgia
- Velocity Clinical Research Site Number : 8400003 - Savannah
Hawaii
- Hawaii Pacific Neuroscience Site Number : 8400103 - Honolulu
Illinois
- Consultants In Neurology- Site Number : 8400011 - Northbrook
Indiana
- Methodist Hospital Site Number : 8400164 - Merrillville
Kansas
- College Park Family Care Center Site Number : 8400044 - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 767 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2025-11-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04458051
The ClinicalTrials.gov registry entry for NCT04458051 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 767 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 1 condition, with Primary Progressive Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04458051 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04458051 about?
NCT04458051 is a clinical study titled "Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)". Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) les...
What is the current status of trial NCT04458051?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 767 participants. The study started on 2020-08-13. Estimated completion is 2025-11-14.
What conditions does trial NCT04458051 study?
This clinical trial studies the following conditions: Primary Progressive Multiple Sclerosis.
What interventions are being tested in trial NCT04458051?
The interventions under investigation include: Placebo (DRUG), Tolebrutinib (DRUG).
Who is sponsoring clinical trial NCT04458051?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04458051 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Progressive Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.