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Bruton's Tyrosine Kinase (BTK) Inhibitor

Tolebrutinib for Multiple Sclerosis

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to final follow-up visit ( month 60 plus 8 weeks)
Awards & highlights

Study Summary

This trial is testing a new drug for safety and effectiveness in treating RMS.

Who is the study for?
This trial is for people with relapsing multiple sclerosis who completed the DRI15928 study. Women must use effective birth control, and menopause should be confirmed by specific criteria. Participants need to consent in writing before any procedures.Check my eligibility
What is being tested?
The long-term safety and effectiveness of Tolebrutinib (SAR442168) are being tested on participants with relapsing multiple sclerosis, focusing on how well it controls disease activity through clinical assessments and imaging techniques.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include those typical of MS treatments such as flu-like symptoms, injection site reactions, allergic reactions, or liver problems. Specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to final follow-up visit ( month 60 plus 8 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to final follow-up visit ( month 60 plus 8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with Potentially Clinically Significant Abnormalities
Secondary outcome measures
Change in Expanded Disability Status Scale (EDSS) from baseline over time
Number of new gadolinium (Gd)-enhancing T1 hyperintense lesions
Number of new or enlarging T2 lesions
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SAR442168Experimental Treatment1 Intervention
SAR442168 : Experimental - Part A: Double-blind period of continued treatment with the respective SAR442168 dose administered in the DRI15928 study until selection of Phase 3 dose. Part B: Open-label period of a single-group treatment with SAR442168 selected Phase 3 dose of 60 mg. All participants will be switched to this 60 mg dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolebrutinib
2020
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,355 Total Patients Enrolled
40 Trials studying Multiple Sclerosis
14,138 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,174 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,466 Patients Enrolled for Multiple Sclerosis

Media Library

Tolebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03996291 — Phase 2
Multiple Sclerosis Research Study Groups: SAR442168
Multiple Sclerosis Clinical Trial 2023: Tolebrutinib Highlights & Side Effects. Trial Name: NCT03996291 — Phase 2
Tolebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03996291 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the upper age limit for this clinical trial set at 18 years or above?

"In accordance with the trial's eligibility conditions, only participants who are aged 18-55 may join."

Answered by AI

What is the total number of medical facilities that are conducting this investigation?

"This trial is currently being implemented at 10 medical sites across the United States. The cities of Dayton, Cullman and Knoxville are among those hosting patients for this study; other locations may be closer to you for your convenience."

Answered by AI

What ultimate goals are being sought by this clinical research endeavor?

"The primary metrics evaluated in this study over the Baseline to final follow-up period ( Month 60 plus 8 weeks) are Participants with Potentially Clinically Significant Abnormalities. Additionally, Secondary endpoints encompass Change in Expanded Disability Status Scale (EDSS), Number of participants wih relapse (Annualized Relapse rate), and Total number of Gd-enhancing T1-hyperintense lesions. The former is measured by standard EDSS assessments across 7 functional domains, while ambulation score will also be recorded."

Answered by AI

Is there still an opportunity to enroll in this research endeavor?

"According to the data presented on clinicaltrials.gov, this study has completed its recruitment phase as of May 10th 2022 and is no longer searching for participants. However, there are still 549 other trials available that may be suitable for prospective volunteers."

Answered by AI

Could you enumerate the potential hazards of Tolebrutinib consumption?

"Tolebrutinib has been classified as a 2 on Power's scale due to the lack of evidence for efficacy, but there is some data indicating it may be safe."

Answered by AI

What are the requirements for participating in this clinical investigation?

"To be eligible for this medical trial, applicants must have been diagnosed with multiple sclerosis and between the ages of 18-55. A total of 125 participants will be accepted into the program."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
2019. "Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03996291.
~14 spots leftby Nov 2024
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