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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Study Purpose

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]). SUBSTUDY: ToleDYNAMIC substudy

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
OR.
  • - The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.
ToleDYNAMIC Substudy: Inclusion criteria are those of the main study.

Exclusion Criteria:

  • - Participants are excluded from the study if any of the following criteria apply: - The participant is at risk for or has a persistent chronic, active (including fever higher than 38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator.
  • - For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection.
  • - Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit.
  • - Current alcohol intake equal to or exceeding the following at the opt-in visit: more than 2 drinks per day for men and more than 1 drink per day for women.
  • - Abnormal ECG during the opt-in visit considered in the Investigator's judgment to be clinically significant, such as QTcF >500 msec, in the context of this study.
  • - A bleeding disorder, known platelet dysfunction, abnormal platelet count (<100,000/microliter), history of significant bleeding event or other conditions and planned procedures that may predispose the participant to excessive bleeding during the study, as judged by the Investigator.
  • - For participants initiating OL tolebrutinib in the LTS17043 study: Confirmed unblinding visit (RMS) or opt-in visit (PMS) alanine aminotransferase (ALT) more than 1.5 × upper limit of normal (ULN) OR aspartate aminotransferase (AST) more than 1.5 × ULN OR alkaline phosphatase more than 2 × ULN (unless caused by non-liver-related disorder or explained by a stable chronic liver disorder) OR total bilirubin more than 1.5 × ULN (unless due to Gilbert syndrome or non-liver-related disorder).
  • - Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
  • - Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial results difficult or that would put the patient at risk by participating in the trial, as judged by the Investigator.
  • - The participant is receiving treatment during the study period with drugs not permitted by the study protocol, including potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ToleDYNAMIC Substudy: Exclusion criteria are those of the main study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06372145
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China, Korea, Republic of, Turkey, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
Additional Details

Participants with relapsing MS from the Phase 2b LTS16004 parent study will continue open-label (OL) tolebrutinib. All participants from the Phase 3 parent studies (EFC16033, EFC16034, EFC16645, and EFC16035) will learn which treatment they received in the parent study:

  • - If from one of the Phase 3 relapsing MS studies and on teriflunomide, an accelerated elimination procedure or a 3-month washout period is required prior to starting OL tolebrutinib.
If on teriflunomide, and benefiting and recommended by the Investigator, the participant may opt to continue teriflunomide outside of the LTS17043 study, if clinically appropriate. If on tolebrutinib, the participant will continue tolebrutinib.
  • - All participants from one of the Phase 3 progressive MS studies will start OL tolebrutinib.
  • - If a participant already started OL tolebrutinib in the Phase 3 parent study this will be continued.
  • - RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.
The treatment duration per participant will be approximately 3 years of OL tolebrutinib.

Arms & Interventions

Arms

Experimental: Tolebrutinib

Participants will receive OL tolebrunitib 60 mg once daily. RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.

Active Comparator: Teriflunomide

participants will receive teriflunomide 14 mg daily RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.

Interventions

Drug: - Tolebrutinib

Pharmaceutical form:Tablet-Route of administration:oral

Drug: - Placebo

Pharmaceutical form:Tablet-Route of administration:oral

Drug: - Teriflunomide

Pharmaceutical form:Tablet-Route of administration:oral

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

HOPE Neurology Site Number : 8409904, Knoxville, Tennessee

Status

Recruiting

Address

HOPE Neurology Site Number : 8409904

Knoxville, Tennessee, 37922

Site Contact

[email protected]

800-633-1610

International Sites

Investigational Site Number : 1560023, Beijing, China

Status

Recruiting

Address

Investigational Site Number : 1560023

Beijing, , 100191

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 1560025, Beijing, China

Status

Recruiting

Address

Investigational Site Number : 1560025

Beijing, , 100730

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 1560005, Chengdu, China

Status

Recruiting

Address

Investigational Site Number : 1560005

Chengdu, , 610041

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 1560019, Chongqing, China

Status

Recruiting

Address

Investigational Site Number : 1560019

Chongqing, , 400016

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 1560035, Fuzhou, China

Status

Recruiting

Address

Investigational Site Number : 1560035

Fuzhou, , 350005

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 1569901, Shanghai, China

Status

Recruiting

Address

Investigational Site Number : 1569901

Shanghai, , 200040

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 1560011, Wuhan, China

Status

Recruiting

Address

Investigational Site Number : 1560011

Wuhan, , 430030

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 1560017, Xi'an, China

Status

Recruiting

Address

Investigational Site Number : 1560017

Xi'an, , 710038

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of

Status

Recruiting

Address

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 135-710

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 7920005, Eskisehir, Turkey

Status

Recruiting

Address

Investigational Site Number : 7920005

Eskisehir, , 26040

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 8049902, Kyiv, Ukraine

Status

Recruiting

Address

Investigational Site Number : 8049902

Kyiv, , 01135

Site Contact

[email protected]

800-633-1610

Investigational Site Number : 8049911, Kyiv, Ukraine

Status

Recruiting

Address

Investigational Site Number : 8049911

Kyiv, , 02091

Site Contact

[email protected]

800-633-1610

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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