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BTK Inhibitor

Tolebrutinib for Multiple Sclerosis (GEMINI 1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 55 years of age at the time of signing the informed consent
Female participant must have a negative highly sensitive pregnancy test at screening and within 24 hours before the first dose of study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 months up to approximately 36 months
Awards & highlights

GEMINI 1 Trial Summary

This trial is testing a new drug, SAR442168, to see if it is better than the existing drug, Aubagio, at reducing relapses in people with relapsing forms of MS. The trial will also look at other measures such as disability progression, MRI lesions, cognitive performance, and quality of life.

Who is the study for?
Adults aged 18-55 with Relapsing Forms of Multiple Sclerosis (RMS) as per the McDonald criteria, having had recent relapses or MRI-detected lesions. They must not be pregnant or breastfeeding and agree to use effective contraception. Excluded are those with primary progressive MS, certain infections like HIV or hepatitis, significant lab abnormalities, conditions affecting study participation, bleeding disorders, psychiatric issues or substance abuse.Check my eligibility
What is being tested?
The trial is testing Tolebrutinib's effectiveness against Teriflunomide in reducing relapse rates in RMS patients. It also examines disability progression, MRI lesion changes, cognitive performance and life quality while assessing safety/tolerability and studying drug metabolism and action.See study design
What are the potential side effects?
Potential side effects may include liver injury signs (as indicated by lab test exclusions), infection risks due to immune system impact (given exclusion for those at risk for infections), bleeding complications (considering exclusion criteria related to platelet dysfunction), among others not listed but inferred from eligibility criteria.

GEMINI 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I have taken a pregnancy test recently and it was negative.
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My disability level allows me to walk without aid or rest for 200 meters.

GEMINI 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months up to approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 months up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses
Secondary outcome measures
Change in CHI3L1 levels
Change in Multiple Sclerosis Quality of Life
Change in cognitive function
+13 more

GEMINI 1 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SAR442168Experimental Treatment2 Interventions
Dose 1 of oral SAR442168 + placebo to match the teriflunomide tablet once daily
Group II: TeriflunomideActive Control2 Interventions
Oral 14 mg oral teriflunomide + placebo to match the SAR442168 tablet once daily
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
2,164 Previous Clinical Trials
3,514,080 Total Patients Enrolled
41 Trials studying Multiple Sclerosis
15,863 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,018,939 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
10,691 Patients Enrolled for Multiple Sclerosis

Media Library

Tolebrutinib (SAR442168) (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04410978 — Phase 3

Frequently Asked Questions

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

Are there any other similar medical studies that have been conducted with Tolebrutinib?

"Tolebrutinib was first studied in 2014 at Site 056001. So far, there have been 27 completed clinical trials and 13 active clinical trials. A notable number of these trials are based in San Francisco, California."

Answered by AI

Has a similar study been conducted in the past?

"Tolebrutinib has been under clinical observation since 2014 when the first trial, sponsored by Genzyme (a Sanofi Company), took place. After the initial 166-person study, Tolebrutinib received Phase 3 approval and has since been the subject of 13 active studies in 62 countries and 314 cities."

Answered by AI

Would I be able to join this clinical study?

"Eligibility criteria for this clinical trial includes a diagnosis of multiple sclerosis and being between 18-55 years old. Around 900 individuals will be admitted into the study."

Answered by AI

Are patients being actively recruited for participation in this research project?

"Unfortunately, this study is not recruiting at the moment. The trial was first announced on June 30th, 2020 and the most recent update was on August 5th, 2022. If you are looking for other studies, 558 trials for patients with multiple sclerosis and 13 studies for Tolebrutinib are currently recruiting."

Answered by AI

Could you explain the risks associated with Tolebrutinib?

"Tolebrutinib has been evaluated in multiple clinical trials and has been shown to be safe and effective. Therefore, our team at Power gives it a safety rating of 3."

Answered by AI

Is this research being conducted with people who are younger than 55 years old?

"The age restriction for this study is that applicants must be between 18-55 years old."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Meridian Clinical Research, LLC-Site Number:8400005
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

applied before in Savannah at a Meridian clinic, for BTK, however it was cancelled.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
2020. "Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04410978.
All > Amyotrophic Lateral Sclerosis
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