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Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
NCT04458051 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04458051 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04458051?
The interventions under investigation include: Placebo (DRUG), Tolebrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04458051?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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