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Immunomodulator

Tolebrutinib for Multiple Sclerosis (GEMINI 2 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 have at least 1 of the following prior to screening: ≥1 documented relapse within the previous year OR ≥2 documented relapses within the previous 2 years OR ≥1 documented Gd enhancing lesion on an MRI scan within the previous year
Participant must have an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 months up to approximately 36 months
Awards & highlights

GEMINI 2 Trial Summary

This trial is testing a new drug, SAR442168, to see if it is better than the current standard of care, Aubagio, at reducing relapses in people with relapsing forms of MS.

Who is the study for?
Adults aged 18-55 with Relapsing Forms of Multiple Sclerosis (RMS) can join this trial. They should have had at least one relapse in the past year or a new lesion on MRI, and an EDSS score ≤5.5. Participants must not be pregnant, agree to use contraception, and provide informed consent.Check my eligibility
What is being tested?
The study is testing Tolebrutinib's effectiveness against Teriflunomide by comparing their impact on the rate of MS relapses, disability progression, brain lesions on MRI, cognitive function and life quality. It also looks at Tolebrutinib's safety and how the body reacts to it.See study design
What are the potential side effects?
Possible side effects include risk of infection due to immune system changes, liver injury signs like abnormal blood tests or fatigue, bleeding disorders or platelet dysfunction which could increase bruising or bleeding risks.

GEMINI 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had at least one relapse or a new lesion on my MRI in the past year.
Select...
My disability level allows me to walk without aid or rest for 200 meters.
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I have been diagnosed with RMS based on the latest criteria.
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I am between 18 and 55 years old.

GEMINI 2 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 protocol defined adjudicated relapses
Secondary outcome measures
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Change in cognitive function
Change in plasma neurofilament light chain (NfL)
+9 more

GEMINI 2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SAR442168Experimental Treatment2 Interventions
Dose 1 of oral SAR442168 daily + 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
2,158 Previous Clinical Trials
3,513,448 Total Patients Enrolled
40 Trials studying Multiple Sclerosis
13,363 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,055 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
10,691 Patients Enrolled for Multiple Sclerosis

Media Library

Teriflunomide HMR1726 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04410991 — Phase 3
Multiple Sclerosis Research Study Groups: SAR442168, Teriflunomide
Multiple Sclerosis Clinical Trial 2023: Teriflunomide HMR1726 Highlights & Side Effects. Trial Name: NCT04410991 — Phase 3
Teriflunomide HMR1726 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04410991 — Phase 3

Frequently Asked Questions

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

In how many different parts of the country is this trial taking place?

"This study is being conducted by 8400088 in Torrance, California, 8400070 in Arcadia, Kentucky, 8400110 in Lexington, Texas, and other research facilities."

Answered by AI

Could you detail the Tolebrutinib's safety record?

"Tolebrutinib has received a score of 3 for safety. This is because Tolebrutinib is in Phase 3 trials, which suggests that not only is the medication effective, but that there is also reliable evidence for its safety."

Answered by AI

How many people are currently signed up to participate in this research project?

"This study is not recruiting patients at the moment, with the last update on the site being from August 5th, 2022. However, there are 558 other trials for patients with multiple sclerosis and 13 trials for Tolebrutinib."

Answered by AI

Who does this trial seek as participants?

"This clinical trial is accepting 900 patients with multiple sclerosis aged 18 and 55. Most importantly, candidates are required to meet the following criteria:The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit.≥1 documented relapse within the previous year OR ≥2 documented relapses within the previous 2 years, OR ≥1 documented"

Answered by AI

Does this research include geriatric patients in the experimental group?

"This clinical trial only allows for enrolment from patients that are aged 18 to 55. There are 43 studies available for minors and 405 for elderly patients."

Answered by AI

Are there other ongoing experiments that test Tolebrutinib's effects?

"The drug tolebrutinib was first trialled in 2014 at ISN 056001. Up until now, there have been a total of 27 completed clinical trials. Presently, 13 different trials are actively recruiting patients, with a concentration of these studies in Torrance, California."

Answered by AI

Are participants still being sought for this research?

"Unfortunately, this specific trial is not looking for new patients at the moment. This is according to the latest update on clinicaltrials.gov, which has the trial listed as last being updated on August 5th, 2022. Although, there are 571 other trials that are currently recruiting."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Investigational Site Number :8400070
Investigational Site Number :1240002
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
North Carolina
California
British Columbia
~20 spots leftby Apr 2024