| CTRI Number |
CTRI/2024/07/071351 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
This study investigated the safety and tolerability of tolebrutinib in people with different forms of multiple sclerosis (MS) |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LTS17043 Amendment Version no. 1 dated 12 Jul 2023 |
Protocol Number |
| NCT06372145 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr J Dinesh Kumar |
| Designation |
Medical Advisor, India and South East Asia Cluster |
| Affiliation |
Sanofi Healthcare India Private Limited |
| Address |
Sanofi House CTS No 117 L&T Business Park Saki Vihar Road, Mumbai, MAHARASHTRA
Mumbai
MAHARASHTRA
400072
India |
| Phone |
09790753835 |
| Fax |
|
| Email |
dineshkumar.jeyaprakash@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Venkateshwar Chaubey |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi Healthcare India Private Limited |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai, Mumbai, Maharashtra, 400 072, India
Mumbai
MAHARASHTRA
400072
India |
| Phone |
9540013386 |
| Fax |
|
| Email |
venkateshwar.chaubey@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Sanofi Healthcare India Private Limited,
Sanofi House CTS No 117 L&T Business Park Saki Vihar Road, Mumbai, MAHARASHTRA- 400072
|
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Primary Sponsor
|
| Name |
Sanofi Healthcare India Pvt Limited (SHIPL) |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai, Mumbai, Maharashtra, 400 072, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Egypt
Estonia
Finland
Georgia
Germany
Greece
Hong Kong
Hungary
India
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
Norway
Peru
Poland
Portugal
Republic of Korea
Romania
Serbia
Singapore
Slovakia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Tunisia
Ukraine
United Arab Emirates
United Kingdom
United States of America
France
Turkey |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayush Agarwal |
All India Institute of Medical Sciences (AIIMS) |
Room No 702, 7th Floor, Department of Neurology,
Neuroscience Centre, Ansari Nagar
New Delhi
DELHI |
8193900444
ayushthetaurian@gmail.com |
| Dr Manish Mahajan |
Artemis Hospital |
Dept of Neurology, Sector 51, Gurugram- 122001
Gurgaon
HARYANA |
8557873567
drmanishneurology@gmail.com |
| Dr Praveen Gupta |
Fortis Memorial Research Institute |
2nd Floor, Clinical Research Department, Fortis Memorial Research Institute, Opp, Huda City Centre, Metro Station,
Sector-44, Pincode-122002
Gurgaon
HARYANA |
9891907903
praveen.gupta@fortishealthcare.com |
| Dr Chithra P |
Government medical college |
Department of Neurology
Government Medical College, Thiruvananthapuram, Pin code-695611
Thiruvananthapuram
KERALA |
9446230317
drthomasiypeneuro@gmail.com |
| Dr Sanjay Ganpat Ramteke |
Jasleen Hospital |
Brain Clinic Jasleen Hospital, Department of Neurology, Opp. Big Bazar, Panchsheel Square, Dhantoli, Nagpur 440012
Nagpur
MAHARASHTRA |
9890332286
ssrt95@yahoo.co.in |
| Dr Lekha Pandit |
Justice K S Hegde Charitable Hospital, Dept. of Neurology, Mangalore |
Dept. of Neurology, Deralakatte, Karnataka 575018
Dakshina Kannada
KARNATAKA |
9845084343
panditmng@gmail.com |
| Dr Dheeraj Khurana |
Postgraduate Institute of Medical Education and Research |
Room No. 18, Department of Neurology, Ground Floor, Block A, Nehru Hospital, PGIMER, Sector 12, Chandigarh, Punjab-160012
Chandigarh
CHANDIGARH |
9815066990
dherajk@yahoo.com |
| Dr Anshu Rohatgi |
Sir Gangaram Hospital |
Admission Block, 4th Floor, Room Number#1412, Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI |
9810159046
rohatgianshu@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Artemis health Sciences, Institutional Ethics Committee |
Approved |
| Central Ethics Committee, Nitte Deemed to be University, University Enclave Medical Sciences Complex Deralakatte |
Submittted/Under Review |
| Human Ethics Committee Government medical college |
Submittted/Under Review |
| IEC, Fortis Memorial Research Institute |
Submittted/Under Review |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, PGIMER |
Approved |
| Jasleen Hospital’s, Ethics Committee, Maharashtra |
Approved |
| Sir Ganga Ram Hospital, Ethics Committee |
Submittted/Under Review |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G35||Multiple sclerosis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SAR442168 60 mg Placebo matched to SAR442168 |
Unit dose strength(s) 60 mg Dose formulation Tablet Dosage level(s) Once daily Route of administration Oral, 36 months treatment |
| Comparator Agent |
Teriflunomide 14 mg Placebo matched to Teriflunomide |
Unit dose strength(s) 14 mg Dose formulation Tablet Dosage level(s) Once daily Route of administration Oral, 36 months treatment |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
I 01. Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS16004 study or 1 of the 4 Phase 3 pivotal tolebrutinib studies (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
I02: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
I 03. The participant is capable of giving signed informed consent. |
|
| ExclusionCriteria |
| Details |
E 01. The participant is at risk for or has a persistent chronic, active (including fever ≥38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator.
E 02. 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. See the Study Manual for further details.
E 03. Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine the long-term safety and tolerability of tolebrutinib in participants with RMS and PMS |
60 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess long-term efficacy of OL tolebrutinib on disability progression, relapse rate (only in participants with RMS), and MRI parameters in participants with RMS and PMS |
60 months |
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The
goal of this Phase 3 extension study is to demonstrate long-term safety and
tolerability of tolebrutinib in participants with different forms of MS who
participated in the Phase 2b LTS16004 study or 1 of the 4 Phase 3 pivotal
tolebrutinib studies. Long-term efficacy will also be assessed by key secondary
endpoints evaluating disability progression, relapse rate (only in participants
with RMS), number of new or enlarging T2-hyperintense lesions, and T2 lesion volume. Together with
evaluation of other secondary and tertiary endpoints, this study will provide a
comprehensive evaluation of the long-term safety, tolerability, and efficacy of
tolebrutinib in the MS population. |