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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06372145




Registration number
NCT06372145
Ethics application status
Date submitted
15/04/2024
Date registered
17/04/2024
Date last updated
22/11/2024

Titles & IDs
Public title
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Scientific title
An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis
Secondary ID [1] 0 0
2023-503631-18
Secondary ID [2] 0 0
LTS17043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Secondary Progressive Multiple Sclerosis 0 0
Progressive Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tolebrutinib
Treatment: Drugs - Placebo
Treatment: Drugs - Teriflunomide

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.


Treatment: Drugs: Tolebrutinib
Pharmaceutical form:Tablet-Route of administration:oral

Treatment: Drugs: Placebo
Pharmaceutical form:Tablet-Route of administration:oral

Treatment: Drugs: Teriflunomide
Pharmaceutical form:Tablet-Route of administration:oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation
Timepoint [1] 0 0
From baseline until the End of study approximately 3 years per participant
Primary outcome [2] 0 0
Number of Participants with Potentially clinically significant abnormalities (PCSAs)
Timepoint [2] 0 0
From baseline until the End of study approximately 3 years per participant
Secondary outcome [1] 0 0
Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies
Timepoint [1] 0 0
From baseline until the End of study approximately 3 years per participant
Secondary outcome [2] 0 0
Annualized Relapse Rate (ARR) for RMS only
Timepoint [2] 0 0
From baseline until the End of study approximately 3 years per participant
Secondary outcome [3] 0 0
Number of new and/or enlarging T2-hyperintense lesions per year
Timepoint [3] 0 0
From baseline until the End of study approximately 3 years per participant
Secondary outcome [4] 0 0
Change from baseline in total volume of T2-hyperintense lesions
Timepoint [4] 0 0
From baseline until the End of study approximately 3 years per participant
Secondary outcome [5] 0 0
ToleDYNAMIC substudy Change from baseline in biomarkers
Timepoint [5] 0 0
From baseline until 12 months per participant

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2029
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Saint Leonards
Recruitment hospital [2] 0 0
Investigational Site Number : 0360006 - Kent Town
Recruitment hospital [3] 0 0
Investigational Site Number : 0360007 - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
5067 - Kent Town
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment outside Australia
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Murcia
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Hsinchu
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Taiwan
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Taipei City
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Akdeniz
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Ankara
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Eskisehir
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State/province [208] 0 0
Istanbul
Country [209] 0 0
Turkey
State/province [209] 0 0
Izmir
Country [210] 0 0
Turkey
State/province [210] 0 0
Izmit
Country [211] 0 0
Turkey
State/province [211] 0 0
Kütahya
Country [212] 0 0
Turkey
State/province [212] 0 0
Samsun
Country [213] 0 0
Ukraine
State/province [213] 0 0
Chernivtsi
Country [214] 0 0
Ukraine
State/province [214] 0 0
Dnipro
Country [215] 0 0
Ukraine
State/province [215] 0 0
Ivano-Frankivsk
Country [216] 0 0
Ukraine
State/province [216] 0 0
Kharkiv
Country [217] 0 0
Ukraine
State/province [217] 0 0
Kyiv
Country [218] 0 0
Ukraine
State/province [218] 0 0
Lutsk
Country [219] 0 0
Ukraine
State/province [219] 0 0
Lviv
Country [220] 0 0
Ukraine
State/province [220] 0 0
Odesa
Country [221] 0 0
Ukraine
State/province [221] 0 0
Vinnytsia
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Devon
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Kent
Country [224] 0 0
United Kingdom
State/province [224] 0 0
London, City Of
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Manchester
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Oxfordshire
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Bristol
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/study/NCT06372145
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06372145