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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1238-1373 | Registry Identifier | ICTRP | |
| 2020-000644-55 | EudraCT Number |
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Primary Objective:
To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS
Secondary Objective:
To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168
Study duration varied per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study were offered to participate in a long term safety study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR442168 | Experimental | Dose 1 of oral SAR442168 daily + placebo to match the teriflunomide tablet once daily |
|
| Teriflunomide | Active Comparator | Oral 14 mg oral teriflunomide + placebo to match the SAR442168 tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolebrutinib | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses | Multiple sclerosis (MS) relapse was defined as a monophasic, acute or subacute onset of new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for >=24 hours with or without recovery, present at normal body temperature, and preceded by >=30 days of clinical stability. | Baseline (Day 1) to approximately 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of 6-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 6-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 6 months that was not attributable to another etiology. |
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Inclusion criteria :
The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit
The participant must have at least 1 of the following prior to screening:
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure:
Plus either:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception/barrier as detailed below
Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions apply:
Is not a WOCBP OR
Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and until accelerated elimination procedure is completed (or for at least 10 days after the last dose of SAR442168, if the case was unblinded) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for the same period of time.
Exclusion criteria:
The participant has been diagnosed with primary progressive multiplesclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiplesclerosis (SPMS)
The participant has a history of infection or may be at risk for infection including but not limited to: HIV, transplantation, live attenuated vaccines, progressive multifocal leukoencephalopathy, tuberculosis, hepatitis B or C, any persistent chronic or active recurring infection
Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
The participant has conditions or situations that would adversely affect participation in this study, including but not limited to:
The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study
At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody
The participant has any of the following:
The participant has a lymphocyte count below the lower limit of normal (LLN) at the screening visit
The presence of psychiatric disturbance or substance abuse
Prior/concomitant therapy
The participant is receiving potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes
The participant is receiving anticoagulant/antiplatelet therapies
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates, PC-Site Number:8400009 | Cullman | Alabama | 35058 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40202623 | Derived | Oh J, Arnold DL, Cree BAC, Ionete C, Kim HJ, Sormani MP, Syed S, Chen Y, Maxwell CR, Benoit P, Turner TJ, Wallstroem E, Wiendl H; Tolebrutinib Phase 3 GEMINI 1 and 2 Trial Group. Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2025 May 15;392(19):1893-1904. doi: 10.1056/NEJMoa2415985. Epub 2025 Apr 8. |
| Label | URL |
|---|---|
| EFC16034 Plain language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 899 participants were randomized in this study in a 1:1 ratio to either teriflunomide 14 milligrams (mg) or tolebrutinib 60 mg group. This was an event-driven (6-month confirmed disability worsening [CDW]) trial with a variable treatment duration (end-of-study [EOS] duration: up to approximately 48 months).
This study was conducted at 154 sites in 25 countries. A total of 1093 participants were screened from 11-Jun-2020 to 08-Aug-2022, of which 194 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriflunomide 14 mg | Participants received teriflunomide 14 mg tablet orally once daily (QD) along with a placebo matched to tolebrutinib orally QD up to approximately 48 months. |
| FG001 | Tolebrutinib 60 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2023 | Jun 3, 2025 |
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| Teriflunomide HMR1726 | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Placebo to match Tolebrutinib | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Placebo to match Teriflunomide | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Baseline (Day 1) to approximately 48 months |
| Time to Onset of 3-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 3-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 3 months that was not attributable to another etiology. | Baseline (Day 1) to approximately 48 months |
| Mean Number of New and/or Enlarging T2-Hyperintense Lesions Per Year | Magnetic resonance imaging (MRI) of the brain was performed to identify number of new and/or enlarging T2-hyperintense lesions defined as the sum of the individual number of new and/or enlarging T2 lesions starting from baseline up to and including the EOS visit. | Baseline (Day 1) to approximately 48 months |
| Mean Number of New Gadolinium-Enhancing T1-Hyperintense Lesions Per Scan | MRI of the brain was performed to identify number of new Gd-enhancing T1-hyperintense lesions defined as the sum of the individual number of new Gd- enhancing T1-hyperintense lesions starting from baseline up to and including the EOS visit. | Baseline (Day 1) to approximately 48 months |
| Change From Baseline in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) at EOS | The SDMT was used to assess processing speed, divided attention, visual scanning, tracking and motor speed. It involved a simple substitution task using a reference key. The number of correct substitutions and number of items completed within a 90 second interval (maximum 110 seconds) were recorded. A decrease of 4 points from baseline on the SDMT was considered meaningful worsening. The score was the number of correctly coded items from 0-110 in 90 seconds; higher scores indicating a better outcome. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test Second Edition (CVLT-II) at EOS | The CVLT-II was a verbal learning and memory test consisting of recall and recognition of a list of 16 words. For each assessment, 5 trials were completed. Total Correct Recall Trials 1-5 was scaled to a normalized T-score metric, which had a mean of 50 and standard deviation of 10, the maximum possible score was 80 and a minimum was 0. Higher values indicated improved cognitive function. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Time to Onset of 6-Month Confirmed Disability Improvement (CDI) as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. CDI was defined as a decrease of >=1 point from baseline in the EDSS score lasting at least 6 months. | Baseline (Day 1) to approximately 48 months |
| Percent Change in Brain Volume Loss at EOS Compared to Month 6 | MRI of the brain was performed at the specified timepoints to detect the changes in brain volume loss. | Month 6 to EOS (up to approximately 48 months) |
| Change From Baseline in Multiple Sclerosis Quality of Life 54 (MSQoL-54) Questionnaire Score at EOS | MSQoL-54 was standardized instrument comprising generic and MS-specific items. This 54-item instrument generated 12 subscales and 2 single-item measures (satisfaction with sexual function [1 item]; change in health [1 item]). 12 subscales were: a: physical health (10 items), b: health perceptions (5 items), c: energy (5 items), d: role limit physical (4 items), e: sexual function (4 items), f: pain (3 items), g: social function (3 items), h: health distress (4 items), i: overall quality of life (2 items), j: emotional well-being (5 items), k: role limitations emotional (3 items) and l: cognitive function (4 items). Physical and mental health composite score were calculated as weighted sum of 'a to h' and 'i to l' subscales respectively. Each composite score was transformed linearly to common 0 (worst) to 100 (best) score range; higher score indicated improved quality of life. Baseline was defined as last available value prior to first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), TEAEs Leading to Permanent Study Intervention Discontinuation and Adverse Events of Special Interest (AESIs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. TEAEs were defined as AEs that developed, worsened or became serious during the treatment period. | From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months |
| Change From Baseline in Plasma Neurofilament Light Chain (NfL) and Serum Chitinase-3 Like Protein-1 (Chi3L1) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in NfL and Chi3L1. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Change From Baseline in Serum Immunoglobulin (Ig) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in IgG and IgM levels. Baseline was defined as the last available value prior to the first dose of study intervention. | Baseline (Day 1) to EOS (up to approximately 48 months) |
| Center for Neurology and Spine-Site Number:8400089 |
| Phoenix |
| Arizona |
| 84018 |
| United States |
| Arcadia Neurology Center-Site Number:8400070 | Arcadia | California | 91006 | United States |
| Multiple Sclerosis Center of California-Site Number:8400135 | Newport Beach | California | 92663 | United States |
| Harbor UCLA-Site Number:8400088 | Torrance | California | 90502 | United States |
| Mountain Neurological Research Center, Inc.-Site Number:8400128 | Basalt | Colorado | 81621 | United States |
| Advanced Neurosciences Research-Site Number:8400025 | Fort Collins | Colorado | 80528 | United States |
| South Florida Neurology Associates-Site Number:8400029 | Boca Raton | Florida | 33487 | United States |
| University of Florida Health-Site Number:8400159 | Gainesville | Florida | 32608 | United States |
| Neurology Associates, PA-Site Number:8400004 | Maitland | Florida | 32761 | United States |
| University of Miami-Site Number:8400063 | Miami | Florida | 33136 | United States |
| Infinity Clinical Research-Site Number:8400008 | Sunrise | Florida | 33351 | United States |
| University of South Florida-Site Number:8400006 | Tampa | Florida | 33612 | United States |
| Meridian Clinical Research-Site Number:8400003 | Savannah | Georgia | 31406 | United States |
| Consultants In Neurology-Site Number:8400011 | Northbrook | Illinois | 60062 | United States |
| Prairie Education and Research Cooperative-Site Number:8400071 | Springfield | Illinois | 62701 | United States |
| Fort Wayne Neurological Center-Site Number:8400039 | Fort Wayne | Indiana | 46804 | United States |
| CHI Saint Joseph Medical Group Neurology-Site Number:8400110 | Lexington | Kentucky | 40509 | United States |
| University of Kentucky-Site Number:8400106 | Lexington | Kentucky | 40536 | United States |
| Norton Neurology MS Services-Site Number:8400127 | Louisville | Kentucky | 40207 | United States |
| The NeuroMedical Center-Site Number:8400057 | Baton Rouge | Louisiana | 70810 | United States |
| International Neurorehabilitation Institute-Site Number:8400034 | Lutherville-Timonium | Maryland | 21093 | United States |
| Wayne State University-Site Number:8400046 | Detroit | Michigan | 48201 | United States |
| Minneapolis Clinic of Neurology-Site Number:8400051 | Minneapolis | Minnesota | 55422 | United States |
| Saint Luke's Hospital-Site Number:8400153 | Kansas City | Missouri | 64111 | United States |
| West Omaha Family Physicians-Site Number:8400139 | Omaha | Nebraska | 68130 | United States |
| University Of Nebraska-Site Number:8400129 | Omaha | Nebraska | 68198 | United States |
| Hackensack University Hospital-Site Number:8400047 | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico-Site Number:8400032 | Albuquerque | New Mexico | 87131 | United States |
| South Shore Neurologic Associates-Site Number:8400100 | Patchogue | New York | 11772 | United States |
| Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120 | Charlotte | North Carolina | 28210 | United States |
| Meridian Clinical Research, LLC-Site Number:8400005 | Raleigh | North Carolina | 27607 | United States |
| Sanford Brain & Spine Center-Site Number:8400126 | Fargo | North Dakota | 58103 | United States |
| Dayton Center for Neurological Disorders-Site Number:8400081 | Centerville | Ohio | 45459 | United States |
| Jefferson Neurology Associates-Site Number:8400016 | Philadelphia | Pennsylvania | 19107 | United States |
| Premier Neurology-Site Number:8400069 | Greer | South Carolina | 29650 | United States |
| Advanced Neuroscience Center-Site Number:8400035 | Franklin | Tennessee | 37064 | United States |
| Sibyl Wray, MD, Neurology, PC-Site Number:8400007 | Knoxville | Tennessee | 37922 | United States |
| Mt Olympus Medical Research-Site Number:8400163 | Katy | Texas | 77450 | United States |
| Neurology Center of San Antonio-Site Number:8400036 | San Antonio | Texas | 78258 | United States |
| Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151 | Sherman | Texas | 75092 | United States |
| Neurological Associates-Site Number:8400097 | Richmond | Virginia | 23229 | United States |
| Wheaton Franciscan Healthcare-Site Number:8400022 | Milwaukee | Wisconsin | 53215 | United States |
| Investigational Site Number :0320004 | CABA | Buenos Aires | C1023AAB | Argentina |
| Investigational Site Number :0320002 | Capital Federal | Buenos Aires | 1012 | Argentina |
| Investigational Site Number :0320001 | CABA | Buenos Aires F.D. | C1061 | Argentina |
| Investigational Site Number :0320003 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number :0320005 | San Miguel de Tucumán | T4000AXL | Argentina |
| Investigational Site Number :0560005 | Bruges | B-8000 | Belgium |
| Investigational Site Number :0560004 | Ghent | 9000 | Belgium |
| Investigational Site Number :0560002 | Mons | 7000 | Belgium |
| Investigational Site Number :0560001 | Overpelt | 3900 | Belgium |
| Investigational Site Number :0760001 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Investigational Site Number :0760002 | Curitiba | 81210-310 | Brazil |
| Investigational Site Number :0760007 | São Paulo | 01228-000 | Brazil |
| Investigational Site Number :1240002 | Edmonton | Alberta | T6G 2C8 | Canada |
| Investigational Site Number : 1240012 | Hamilton | Ontario | L8L 2X2 | Canada |
| Investigational Site Number :1240014 | London | Ontario | N6A 5A5 | Canada |
| Investigational Site Number :1240005 | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Investigational Site Number :1240006 | Gatineau | J8Y1W2 | Canada |
| Investigational Site Number :1240021 | Québec | G1W 4R4 | Canada |
| Investigational Site Number :1520002 | Santiago | Reg Metropolitana de Santiago | 7650568 | Chile |
| Investigational Site Number :1520005 | Santiago | Reg Metropolitana de Santiago | 833-0024 | Chile |
| Investigational Site Number :1520001 | Santiago | Reg Metropolitana de Santiago | 8380456 | Chile |
| Investigational Site Number :1520003 | Santiago | Reg Metropolitana de Santiago | 8431657 | Chile |
| Investigational Site Number :1520006 | Concepción | Chile |
| Investigational Site Number :1520004 | Valdivia | 5110683 | Chile |
| Investigational Site Number :1910001 | Zagreb | 10000 | Croatia |
| Investigational Site Number :1910002 | Zagreb | 10000 | Croatia |
| Investigational Site Number :1910003 | Zagreb | 10000 | Croatia |
| Investigational Site Number :2030002 | Brno | 65691 | Czechia |
| Investigational Site Number :2030011 | Hradec Králové | 50005 | Czechia |
| Investigational Site Number :2030001 | Jihlava | 58633 | Czechia |
| Investigational Site Number :2030008 | Prague | 10034 | Czechia |
| Investigational Site Number :2030005 | Praha 5 - Motol | 15006 | Czechia |
| Investigational Site Number :2500019 | Besançon | 25000 | France |
| Investigational Site Number :2500018 | Bordeaux | France |
| Investigational Site Number :2500011 | Bron | 69500 | France |
| Investigational Site Number :2500005 | Clermont-Ferrand | 63003 | France |
| Investigational Site Number :2500006 | Montpellier | 34295 | France |
| Investigational Site Number :2500010 | Nantes | 44093 | France |
| Investigational Site Number :2500002 | Nice | 06002 | France |
| Investigational Site Number :2500017 | Nîmes | 30029 | France |
| Investigational Site Number :2500007 | Paris | 75019 | France |
| Investigational Site Number :2500004 | Poissy | 78300 | France |
| Investigational Site Number :2500003 | Rennes | 35033 | France |
| Investigational Site Number :2500001 | Strasbourg | 67098 | France |
| Investigational Site Number :2760005 | Bayreuth | 95445 | Germany |
| Investigational Site Number :2760015 | Berlin | 10713 | Germany |
| Investigational Site Number :2760014 | Berlin | 12099 | Germany |
| Investigational Site Number :2760020 | Bochum | 44791 | Germany |
| Investigational Site Number :2760012 | Essen | 45147 | Germany |
| Investigational Site Number :2760003 | Würzburg | 97070 | Germany |
| Investigational Site Number :3000001 | Athens | 115 28 | Greece |
| Investigational Site Number :3000006 | Athens | 11535 | Greece |
| Investigational Site Number :3000002 | Athens | 12462 | Greece |
| Investigational Site Number :3000007 | Athens | 15125 | Greece |
| Investigational Site Number :3000009 | Athens | Greece |
| Investigational Site Number :3000004 | Larissa | 41110 | Greece |
| Investigational Site Number :3000003 | Thessaloniki | 546 36 | Greece |
| Investigational Site Number :3480105 | Budapest | 1135 | Hungary |
| Investigational Site Number :3480102 | Budapest | 1145 | Hungary |
| Investigational Site Number :3480106 | Kaposvár | 7400 | Hungary |
| Investigational Site Number :3480103 | Tatabánya | 2800 | Hungary |
| Investigational Site Number :3560005 | Chandigarh | 160012 | India |
| Investigational Site Number :3560007 | Gurgaon | 122001 | India |
| Investigational Site Number :3560008 | Gurgaon | 122002 | India |
| Investigational Site Number :3560002 | New Delhi | 110060 | India |
| Investigational Site Number :3560004 | Thiruvananthapuram | 695004 | India |
| Investigational Site Number :3760002 | Ashkelon | 78278 | Israel |
| Investigational Site Number :3760003 | Haifa | 31096 | Israel |
| Investigational Site Number :3760006 | Rehovot | 76100 | Israel |
| Investigational Site Number :3760004 | Safed | 13100 | Israel |
| Investigational Site Number :3760001 | Tel Litwinsky | 52621 | Israel |
| Investigational Site Number :4280002 | Riga | LV-1002 | Latvia |
| Investigational Site Number :4280003 | Riga | LV-1005 | Latvia |
| Investigational Site Number :5280001 | Amsterdam | 1081 GN | Netherlands |
| Investigational Site Number :5780002 | Namsos | 7800 | Norway |
| Investigational Site Number :5780001 | Oslo | 0450 | Norway |
| Investigational Site Number :6200001 | Braga | 4710-243 | Portugal |
| Investigational Site Number :6200005 | Coimbra | 3000-075 | Portugal |
| Investigational Site Number :6200011 | Lisbon | 1162-050 | Portugal |
| Investigational Site Number :6200006 | Lisbon | 1649-035 | Portugal |
| Investigational Site Number :6200002 | Matosinhos Municipality | 4464-513 | Portugal |
| Investigational Site Number :6200010 | Porto | 4099-001 | Portugal |
| Investigational Site Number :6200004 | Santa Maria da Feira | 4520-211 | Portugal |
| San Juan MS Center-Site Number:8400015 | Guaynabo | 00969 | Puerto Rico |
| Investigational Site Number :6430006 | Barnaul | 656024 | Russia |
| Investigational Site Number :6430013 | Bryansk | 241033 | Russia |
| Investigational Site Number :6430001 | Kazan' | 420021 | Russia |
| Investigational Site Number :6430010 | Kirov | 610998 | Russia |
| Investigational Site Number :6430007 | Moscow | 117997 | Russia |
| Investigational Site Number :6430005 | Moscow | 127015 | Russia |
| Investigational Site Number :6430003 | Novosibirsk | 630087 | Russia |
| Investigational Site Number :6430014 | Saint Petersburg | 192242 | Russia |
| Investigational Site Number :6430004 | Saint Petersburg | 197022 | Russia |
| Investigational Site Number :6430002 | Saint Petersburg | 197110 | Russia |
| Investigational Site Number :6430011 | Saransk | 430032 | Russia |
| Investigational Site Number :6430012 | Yekaterinburg | 620102 | Russia |
| Investigational Site Number :6880001 | Belgrade | 11000 | Serbia |
| Investigational Site Number :6880003 | Belgrade | 11000 | Serbia |
| Investigational Site Number :6880006 | Belgrade | 11000 | Serbia |
| Investigational Site Number :6880002 | Kragujevac | 34000 | Serbia |
| Investigational Site Number :6880004 | Niš | 18000 | Serbia |
| Investigational Site Number :6880005 | Novi Sad | 21000 | Serbia |
| Investigational Site Number :7030001 | Bratislava | 82606 | Slovakia |
| Investigational Site Number :7030002 | Martin | 03659 | Slovakia |
| Investigational Site Number :7030004 | Nitra | 950 01 | Slovakia |
| Investigational Site Number :4100001 | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Investigational Site Number :4100003 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number :4100006 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number :4100002 | Seoul | Seoul-teukbyeolsi | 06351 | South Korea |
| Investigational Site Number :7240011 | Seville | Andalusia | 41009 | Spain |
| Investigational Site Number :7240006 | Barcelona | Barcelona [Barcelona] | 08036 | Spain |
| Investigational Site Number :7240009 | Barakaldo | Bizkaia | 48903 | Spain |
| Investigational Site Number :7240004 | Salt | Girona [Gerona] | 17190 | Spain |
| Investigational Site Number :7240013 | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Investigational Site Number :7240008 | A Coruña | 15006 | Spain |
| Investigational Site Number :7240007 | L'Hospitalet de Llobregat | 08907 | Spain |
| Investigational Site Number :7240005 | Lleida | 25198 | Spain |
| Investigational Site Number :7240003 | Madrid | 28007 | Spain |
| Investigational Site Number :7240001 | Madrid | 28034 | Spain |
| Investigational Site Number :7240002 | Madrid | 28040 | Spain |
| Investigational Site Number :7240010 | Málaga | 29010 | Spain |
| Investigational Site Number :7240012 | Pozuelo de Alarcón | 28223 | Spain |
| Investigational Site Number :7560003 | Aarau | 5001 | Switzerland |
| Investigational Site Number :7560002 | Bern | 3010 | Switzerland |
| Investigational Site Number :7560004 | Lugano | 6903 | Switzerland |
| Investigational Site Number :7920002 | Ankara | 06100 | Turkey (Türkiye) |
| Investigational Site Number :7920005 | Besevler / Ankara | 06500 | Turkey (Türkiye) |
| Investigational Site Number :7920006 | Istanbul | 34896 | Turkey (Türkiye) |
| Investigational Site Number :7920004 | Kuttahta | 43100 | Turkey (Türkiye) |
| Investigational Site Number :7920001 | Samsun | Turkey (Türkiye) |
| Investigational Site Number :7920003 | Trabzon | 61080 | Turkey (Türkiye) |
| Investigational Site Number :8040020 | Chernihiv | 14029 | Ukraine |
| Investigational Site Number :8040002 | Chernivtsi | 58000 | Ukraine |
| Investigational Site Number :8040019 | Chernivtsi | 58023 | Ukraine |
| Investigational Site Number :8040005 | Dnipro | 49005 | Ukraine |
| Investigational Site Number :8040022 | Kharkiv | 61103 | Ukraine |
| Investigational Site Number :8040018 | Kharkiv | 61166 | Ukraine |
| Investigational Site Number :8040007 | Kyiv | 02091 | Ukraine |
| Investigational Site Number :8040006 | Lviv | 79013 | Ukraine |
| Investigational Site Number :8040003 | Vinnytsia | 21050 | Ukraine |
| Investigational Site Number :8260003 | Exeter | Devon | EX2 5DW | United Kingdom |
| Investigational Site Number :8260016 | Canterbury | Kent | CT1 3NG | United Kingdom |
| Investigational Site Number :8260009 | Bristol | BS10 5NB | United Kingdom |
Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 46 months.
| Randomized and Treated |
|
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on the randomized population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriflunomide 14 mg | Participants received teriflunomide 14 mg tablet orally QD along with a placebo matched to tolebrutinib orally QD up to approximately 48 months. |
| BG001 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 46 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses | Multiple sclerosis (MS) relapse was defined as a monophasic, acute or subacute onset of new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for >=24 hours with or without recovery, present at normal body temperature, and preceded by >=30 days of clinical stability. | The intent-to-treat (ITT) population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Number | 95% Confidence Interval | relapses per participant year | Baseline (Day 1) to approximately 48 months |
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| Secondary | Time to Onset of 6-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 6-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 6 months that was not attributable to another etiology. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Median | Full Range | months | Baseline (Day 1) to approximately 48 months |
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| Secondary | Time to Onset of 3-Month Confirmed Disability Worsening as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. Time to onset of 3-month CDW was defined as the time from randomization to the onset of a confirmed, sustained increase from baseline in EDSS score (of >=1.5 points when the baseline score was 0, of >=1.0 point when the baseline score was 0.5 to <=5.5, of >=0.5 points when the baseline EDSS score was >5.5) over at least 3 months that was not attributable to another etiology. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Median | Full Range | months | Baseline (Day 1) to approximately 48 months |
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| Secondary | Mean Number of New and/or Enlarging T2-Hyperintense Lesions Per Year | Magnetic resonance imaging (MRI) of the brain was performed to identify number of new and/or enlarging T2-hyperintense lesions defined as the sum of the individual number of new and/or enlarging T2 lesions starting from baseline up to and including the EOS visit. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Mean | 95% Confidence Interval | number of new and/or enlarging T2lesions | Baseline (Day 1) to approximately 48 months |
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| Secondary | Mean Number of New Gadolinium-Enhancing T1-Hyperintense Lesions Per Scan | MRI of the brain was performed to identify number of new Gd-enhancing T1-hyperintense lesions defined as the sum of the individual number of new Gd- enhancing T1-hyperintense lesions starting from baseline up to and including the EOS visit. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Mean | 95% Confidence Interval | number of new Gd-enhancing T1 lesions | Baseline (Day 1) to approximately 48 months |
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| Secondary | Change From Baseline in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) at EOS | The SDMT was used to assess processing speed, divided attention, visual scanning, tracking and motor speed. It involved a simple substitution task using a reference key. The number of correct substitutions and number of items completed within a 90 second interval (maximum 110 seconds) were recorded. A decrease of 4 points from baseline on the SDMT was considered meaningful worsening. The score was the number of correctly coded items from 0-110 in 90 seconds; higher scores indicating a better outcome. Baseline was defined as the last available value prior to the first dose of study intervention. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test Second Edition (CVLT-II) at EOS | The CVLT-II was a verbal learning and memory test consisting of recall and recognition of a list of 16 words. For each assessment, 5 trials were completed. Total Correct Recall Trials 1-5 was scaled to a normalized T-score metric, which had a mean of 50 and standard deviation of 10, the maximum possible score was 80 and a minimum was 0. Higher values indicated improved cognitive function. Baseline was defined as the last available value prior to the first dose of study intervention. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | T-score | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Time to Onset of 6-Month Confirmed Disability Improvement (CDI) as Assessed by Expanded Disability Status Scale | The EDSS was a disability scale that assessed the following 7 functional domains: visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral, and bowel/bladder. The total EDSS score ranged from 0 (normal) to 10 (death due to MS), increasing in increments of 0.5 points. Higher scores indicated increased disability. CDI was defined as a decrease of >=1 point from baseline in the EDSS score lasting at least 6 months. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. | Posted | Median | Full Range | months | Baseline (Day 1) to approximately 48 months |
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| Secondary | Percent Change in Brain Volume Loss at EOS Compared to Month 6 | MRI of the brain was performed at the specified timepoints to detect the changes in brain volume loss. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints are reported. | Posted | Least Squares Mean | Standard Error | percent change | Month 6 to EOS (up to approximately 48 months) |
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| Secondary | Change From Baseline in Multiple Sclerosis Quality of Life 54 (MSQoL-54) Questionnaire Score at EOS | MSQoL-54 was standardized instrument comprising generic and MS-specific items. This 54-item instrument generated 12 subscales and 2 single-item measures (satisfaction with sexual function [1 item]; change in health [1 item]). 12 subscales were: a: physical health (10 items), b: health perceptions (5 items), c: energy (5 items), d: role limit physical (4 items), e: sexual function (4 items), f: pain (3 items), g: social function (3 items), h: health distress (4 items), i: overall quality of life (2 items), j: emotional well-being (5 items), k: role limitations emotional (3 items) and l: cognitive function (4 items). Physical and mental health composite score were calculated as weighted sum of 'a to h' and 'i to l' subscales respectively. Each composite score was transformed linearly to common 0 (worst) to 100 (best) score range; higher score indicated improved quality of life. Baseline was defined as last available value prior to first dose of study intervention. | The ITT population included all randomized participants according to the intervention group allocated by the randomization, irrespective of the study intervention received. Only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), TEAEs Leading to Permanent Study Intervention Discontinuation and Adverse Events of Special Interest (AESIs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. TEAEs were defined as AEs that developed, worsened or became serious during the treatment period. | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. | Posted | Count of Participants | Participants | From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months |
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| Secondary | Change From Baseline in Plasma Neurofilament Light Chain (NfL) and Serum Chitinase-3 Like Protein-1 (Chi3L1) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in NfL and Chi3L1. Baseline was defined as the last available value prior to the first dose of study intervention. | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Median | Inter-Quartile Range | picogram/milliliter | Baseline (Day 1) to EOS (up to approximately 48 months) |
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| Secondary | Change From Baseline in Serum Immunoglobulin (Ig) Levels at EOS | Blood samples were collected at specified timepoints to assess change from baseline in IgG and IgM levels. Baseline was defined as the last available value prior to the first dose of study intervention. | The safety population included all randomized participants exposed to the study intervention, regardless of the amount of exposure, analyzed according to the intervention actually received. Only participants with data collected at specified timepoints for the specified categories are reported. | Posted | Median | Inter-Quartile Range | gram per liter | Baseline (Day 1) to EOS (up to approximately 48 months) |
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From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months. Deaths were collected from baseline (Day 1) up to end of follow-up, approximately 48 months.
Analysis was performed on the safety population. All-cause mortality was performed on the randomized population. This was an event-driven (6-month CDW) trial with a variable treatment duration (EOS duration: up to approximately 48 months)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriflunomide 14 mg | Participants received teriflunomide 14 mg tablet orally QD along with a placebo matched to tolebrutinib orally QD up to approximately 48 months. | 2 | 452 | 37 | 451 | 313 | 451 |
| EG001 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 46 months. | 1 | 447 | 49 | 447 | 279 | 447 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Sinusitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Bone Abscess | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Dengue Fever | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Escherichia Pyelonephritis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Gastroenteritis Norovirus | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Oligodendroglioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
| |
| Uterine Leiomyoma Necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.0 | Systematic Assessment |
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| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Mental Fatigue | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Somatic Symptom Disorder | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Guillain-Barre Syndrome | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
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| Multiple Sclerosis | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
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| Multiple Sclerosis Relapse | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
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| Relapsing Multiple Sclerosis | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
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| Relapsing-Remitting Multiple Sclerosis | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
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| Trigeminal Neuralgia | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDra 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDra 27.0 | Systematic Assessment |
| |
| Vertigo Positional | Ear and labyrinth disorders | MedDra 27.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
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| Gastric Haemorrhage | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
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| Bile Duct Stone | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Drug-Induced Liver Injury | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hepatitis Acute | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Calculus Urethral | Renal and urinary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDra 27.0 | Systematic Assessment |
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| Urethral Disorder | Renal and urinary disorders | MedDra 27.0 | Systematic Assessment |
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| Abnormal Uterine Bleeding | Reproductive system and breast disorders | MedDra 27.0 | Systematic Assessment |
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| Adenomyosis | Reproductive system and breast disorders | MedDra 27.0 | Systematic Assessment |
| |
| Heavy Menstrual Bleeding | Reproductive system and breast disorders | MedDra 27.0 | Systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Gun Shot Wound | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Ligament Rupture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
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| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
| |
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 27.0 | Systematic Assessment |
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The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2024 | Jun 3, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C527525 | teriflunomide |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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A hierarchical testing procedure was used to control the overall type I error. |
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| Units | Counts |
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| OG001 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 46 months. |
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| OG001 |
| Tolebrutinib 60 mg |
Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 46 months. |
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