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A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
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.
Study 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-16
Primary completion: 2029-04-30
Study completion finish: 2029-04-30
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06372145
Intervention or treatment
DRUG: Tolebrutinib
DRUG: Placebo
DRUG: Teriflunomide
Conditions
- • Relapsing Multiple Sclerosis
- • Secondary Progressive Multiple Sclerosis
- • Progressive Relapsing Multiple Sclerosis
Find a site
Closest Location:
Investigational Site Number : 0360001
Research sites nearby
Select from list below to view details:
Investigational Site Number : 0360001
Saint Leonards, New South Wales, Australia
Investigational Site Number : 0360006
Kent Town, South Australia, Australia
Investigational Site Number : 0360007
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Tolebrutinib
| DRUG: Tolebrutinib
|
ACTIVE_COMPARATOR: Teriflunomide
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 | Not Specified | From baseline until the End of study approximately 3 years per participant |
| Number of Participants with Potentially clinically significant abnormalities (PCSAs) | Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs and safety findings on MRI during the study period. | From baseline until the End of study approximately 3 years per participant |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| 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 | Time to onset is defined as a sustained increase from baseline EDSS (pivotal trial) of: * RMS: ≥1.5 points when the baseline score is 0, ≥1.0 point when the baseline score is 0.5 to ≤5.5 or ≥0.5 point when the baseline score is \>5.5 * PPMS: ≥1.0 point when the baseline score is ≤5.5 or ≥0.5 point when the baseline score is \>5.5 * NRSPMS: ≥1.0 point when the baseline score is ≤5.0 or ≥0.5 point when the baseline score is \>5.0 | From baseline until the End of study approximately 3 years per participant |
| Annualized Relapse Rate (ARR) for RMS only | ARR during the OL treatment period assessed by confirmed protocol-defined relapses | From baseline until the End of study approximately 3 years per participant |
| Number of new and/or enlarging T2-hyperintense lesions per year | Not Specified | From baseline until the End of study approximately 3 years per participant |
| Change from baseline in total volume of T2-hyperintense lesions | Not Specified | From baseline until the End of study approximately 3 years per participant |
| ToleDYNAMIC substudy Change from baseline in biomarkers | Not Specified | From baseline until 12 months per participant |
Frequently Asked Questions
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