Trial Title:
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
NCT ID:
NCT06372145
Condition:
Relapsing Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
Conditions: Official terms:
Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Teriflunomide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tolebrutinib
Description:
Pharmaceutical form:Tablet-Route of administration:oral
Arm group label:
Tolebrutinib
Other name:
SAR442168
Intervention type:
Drug
Intervention name:
Placebo
Description:
Pharmaceutical form:Tablet-Route of administration:oral
Arm group label:
Teriflunomide
Arm group label:
Tolebrutinib
Intervention type:
Drug
Intervention name:
Teriflunomide
Description:
Pharmaceutical form:Tablet-Route of administration:oral
Arm group label:
Teriflunomide
Other name:
Aubagio
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
Detailed description:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HOPE Neurology Site Number : 8409904
Address:
City:
Knoxville
Zip:
37922
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1560023
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1560025
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1560005
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1560019
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1560035
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1569901
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1560011
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 1560017
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 4100002
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 7920005
Address:
City:
Eskisehir
Zip:
26040
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 8049902
Address:
City:
Kyiv
Zip:
01135
Country:
Ukraine
Status:
Recruiting
Facility:
Name:
Investigational Site Number : 8049911
Address:
City:
Kyiv
Zip:
02091
Country:
Ukraine
Status:
Recruiting
Start date:
April 16, 2024
Completion date:
April 30, 2029
Lead sponsor:
Agency:
Sanofi
Agency class:
Industry
Source:
Sanofi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06372145
