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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04411641
Registration number
NCT04411641
Ethics application status
Date submitted
28/05/2020
Date registered
2/06/2020
Date last updated
2/07/2025
Titles & IDs
Public title
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
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Scientific title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
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Secondary ID [1]
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U1111-1246-7768
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Secondary ID [2]
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EFC16645
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Universal Trial Number (UTN)
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Trial acronym
HERCULES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-relapsing Secondary Progressive Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tolebrutinib
Treatment: Drugs - Placebo to match Tolebrutinib
Experimental: SAR442168 - 60 mg of oral SAR442168 once daily
Placebo comparator: Placebo - Placebo tablet to match SAR442168 once daily
Treatment: Drugs: Tolebrutinib
Pharmaceutical form: Film-coated tablet Route of administration: Oral
Treatment: Drugs: Placebo to match Tolebrutinib
Pharmaceutical form: Film-coated tablet Route of administration: Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Onset of 6-Month Confirmed Disability Progression (CDP) as Assessed by Expanded Disability Status Scale (EDSS)
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Assessment method [1]
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The EDSS is a disability scale that assesses the following 7 functional domains: visual, brainstem, pyramidal \[motor\], cerebellar \[coordination\], sensory, cerebral, and bowel/bladder. The total EDSS ranges from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]) (0.5 increments from 1-10; next increase after 0 is 1). Higher scores indicated increased disability. Time to onset of 6-month CDP was defined as the time from randomization to the onset of a sustained increase from baseline in EDSS score of \>=1.0 point from the baseline EDSS score when the baseline score was \<=5.0 or of \>=0.5 points when the baseline EDSS score was \>5.0 confirmed after a minimum 6-month interval.
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Timepoint [1]
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Baseline (Day 1) up to approximately 47 months
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Secondary outcome [1]
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Time to Onset of 3-month Confirmed Disability Progression as Assessed by Expanded Disability Status Scale
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Assessment method [1]
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The EDSS is a disability scale that assesses the following 7 functional domains: visual, brainstem, pyramidal \[motor\], cerebellar \[coordination\], sensory, cerebral, and bowel/bladder. The total EDSS ranges from 0 (normal) to 10 (death due to MS) (0.5 increments from 1-10; next increase after 0 is 1). Higher scores indicated increased disability. Time to onset of 3-month CDP was defined as the time from randomization to the onset of a sustained increase from baseline in EDSS score (of \>=1.0 point from the baseline EDSS score when the baseline score is \<=5.0, of \>=0.5 points when the baseline EDSS score is \>5.0) confirmed after a minimum 3-month interval. The confirmation of 3-month CDP followed the same criteria as that of 6-month CDP.
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Timepoint [1]
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Baseline (Day 1) up to approximately 47 months
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Secondary outcome [2]
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Mean Number of New and/or Enlarging T2-hyperintense Lesions Per Year
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Assessment method [2]
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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 from baseline up to and including the EOS visit.
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Timepoint [2]
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Baseline (Day 1) up to approximately 47 months
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Secondary outcome [3]
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Time to Onset of Sustained 20% Increase in the 9-hole Peg Test (HPT) for at Least 3 Months
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Assessment method [3]
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The 9-HPT is a brief, standardized, quantitative test of upper extremity function and the time to complete the 9-HPT is used to assess a participant's manual dexterity and fine motor skills. A participant was asked to place the pegs into the holes and remove them with the dominant and non-dominant hand; two successful trials for each hand. The amount of time (in seconds) required to place and remove all nine pegs was recorded for each trial (ranging from 10 to 300 seconds). The mean time to test completion served for assessment of the participant's hand dexterity. Higher value indicated worse outcome. An increase of \>20% from the baseline in the 9-HPT was considered meaningful worsening; time to onset of sustained 20% increase for at least 3 months is presented.
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Timepoint [3]
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Baseline (Day 1) up to approximately 47 months
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Secondary outcome [4]
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Time to Onset of Sustained 20% Increase in the Timed 25-foot Walk (T25-FW) for at Least 3 Months
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Assessment method [4]
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The T25-FW test is a quantitative mobility and leg function performance test used to assess a participant's walking ability. A participant was directed to one end of a clearly marked 25-foot course and instructed to walk 25 feet as quickly as safely possible for 2 trials. The amount of time (in seconds) to walk 25 feet was recorded (ranging from 2.2 to 180 seconds). The mean walk time was used for assessment of the participant's walking ability. Higher value indicated worse outcome. An increase of \>20% from the baseline in the T25-FW test was considered meaningful worsening; time to onset of sustained 20% increase for at least 3 months is presented.
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Timepoint [4]
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Baseline (Day 1) up to approximately 47 months
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Secondary outcome [5]
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Time to Onset of 6-month Confirmed Disability Improvement (CDI) as Assessed by Expanded Disability Status Scale
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Assessment method [5]
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The EDSS is a disability scale that assesses the following 7 functional domains: visual, brainstem, pyramidal \[motor\], cerebellar \[coordination\], sensory, cerebral, and bowel/bladder. The total EDSS ranges from 0 (normal) to 10 (death due to MS) (0.5 increments from 1-10; next increase after 0 is 1). Higher scores indicated increased disability. CDI was defined as a \>=1 point decrease in the EDSS score from baseline confirmed over at least 6 months.
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Timepoint [5]
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Baseline (Day 1) up to approximately 47 months
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Secondary outcome [6]
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Percent Change in Brain Volume at EOS Compared to Month 6
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Assessment method [6]
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MRI of the brain was performed to evaluate percent change in brain volume which is considered as a marker of the central nervous system degenerative process. Least squares (LS) mean is presented.
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Timepoint [6]
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Month 6 to EOS (up to approximately 47 months)
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Secondary outcome [7]
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Change From Baseline in Cognitive Function as Assessed by Symbol Digit Modalities Test (SDMT) at EOS
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Assessment method [7]
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The SDMT is used to assess processing speed, divided attention, visual scanning, tracking and motor speed. It involves 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) are recorded. A decrease of 4 points from baseline on the SDMT is considered meaningful worsening. The score was the number of correctly coded items from 0-110 in 90 seconds; higher scores indicated better outcome. LS mean is presented. Baseline was defined as the last available value prior to the first dose of study intervention.
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Timepoint [7]
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Baseline (Day 1) to EOS (up to approximately 47 months)
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Secondary outcome [8]
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Change From Baseline in Cognitive Function as Assessed by California Verbal Learning Test Second Edition (CVLT-II) at EOS
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Assessment method [8]
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The CVLT-II is a verbal learning and memory test consisting of recall and recognition of a list of 16 words. The list was read by the examiner, participants listened to the list and reported as many of the items as possible. For each assessment, 5 trials were completed. Standardized scores were used for analysis. The maximum possible score was 80 and a minimum was 0. A higher score indicated better recall meaning improved cognitive function. LS mean is presented. Baseline was defined as the last available value prior to the first dose of study intervention.
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Timepoint [8]
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Baseline (Day 1) to EOS (up to approximately 47 months)
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Secondary outcome [9]
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Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Questionnaire Score at EOS
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Assessment method [9]
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MSQoL-54 is standardized instrument with generic and MS-specific items which generates 12 subscales \& 2 single-item measures (satisfaction with sexual function \[1 item\] \& change in health \[1 item\].12 subscales are as follows:a:physical health (10 items),b:health perceptions (5 items), c:energy (5 items),d:role limitation 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 health composite score was calculated as weighted sum of 'a to h' subscales and mental health composite score was calculated as weighted sum of 'i to l' subscales mentioned above.Each composite score was transformed linearly to common 0 (worst) to 100 (best) score range;LS mean is presented.Higher score indicated improved QoL.Baseline:last available value prior to first dose of study intervention.
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Timepoint [9]
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Baseline (Day 1) to EOS (up to approximately 47 months)
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Secondary outcome [10]
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Number of Participants With Treatment-emergent Adverse Events (AEs), Treatment-emergent Serious AEs, Treatment-emergent AEs Leading to Permanent Study Intervention Discontinuation, and Treatment-emergent Adverse Events of Special Interest (AESIs)
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Assessment method [10]
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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 TE period.
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Timepoint [10]
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From first dose of study intervention (Day 1) up to end of follow-up, up to approximately 47 months
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Secondary outcome [11]
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Maximum Observed Plasma Concentration (Cmax) of Tolebrutinib and M2 Metabolite
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Assessment method [11]
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Blood samples were collected at specified timepoints to assess Cmax of tolebrutinib and M2 metabolite using a population pharmacokinetics (PopPK) model.
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Timepoint [11]
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30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12
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Secondary outcome [12]
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Time to Maximum Observed Plasma Concentration (Tmax) of Tolebrutinib and M2 Metabolite
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Assessment method [12]
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Blood samples were collected at specified timepoints to assess Tmax of tolebrutinib and M2 metabolite using a PopPK model.
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Timepoint [12]
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30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12
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Secondary outcome [13]
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Area Under the Plasma Concentration-time Curve Over the Last 24-hours Dosing Interval (AUC0-24) of Tolebrutinib and M2 Metabolite
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Assessment method [13]
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Blood samples were collected at specified timepoints to assess AUC0-24 of tolebrutinib and M2 metabolite using a PopPK model.
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Timepoint [13]
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30-90 minutes post-dose at Months 6, 9, and 12 and 2.5-5 hours post-dose at Months 6 and 12
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Secondary outcome [14]
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Change From Baseline in Plasma Neurofilament Light Chain (NfL) and Serum Chitinase-3 Like Protein-1 (Chi3L1) Levels at EOS
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline (Day 1) to EOS (up to approximately 47 months)
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Secondary outcome [15]
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Change From Baseline in Cluster of Differentiation (CD)19+ B Cells at EOS
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Assessment method [15]
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Blood samples were collected at specified timepoints to assess change from baseline in CD19+ B cells. Baseline was defined as the last available value prior to the first dose of study intervention.
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Timepoint [15]
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Baseline (Day 1) to EOS (up to approximately 47 months)
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Secondary outcome [16]
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Change From Baseline in Serum Immunoglobulin (Ig) Levels at EOS
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline (Day 1) to EOS (up to approximately 47 months)
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Eligibility
Key inclusion criteria
Inclusion criteria :
* 18 to 60 years of age inclusive
* Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria
* Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at screening
* The participant must have documented evidence of disability progression observed during the 12 months before screening
* Absence of clinical relapses for at least 24 months
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
* Is not a WOCBP OR
* Is a WOCBP and agrees to use an acceptable contraceptive method
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* The participant has conditions that would adversely affect study participation such as short life expectancy.
* Evidence of infection with human immuodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections that would adversely affect study participation.
* Persistent chronic or active or recurring system infection, that may adversely affect participation or IMP administration in this study, as judged by the Investigator.
* History of malignancy within 5 years prior to screening.
* History of alcohol or drug abuse within 1 year prior to screening.
* Hospitalized for psychiatric disease within 2 years prior to screening.
* Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at screening
* Bleeding disorder, known platelet dysfunctionat any time prior to the screening visit
* A platelet count <150 000/µL at the screening visit
* A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal bleeding.
* Lymphocyte count below the lower limit of normal at screening.
* Recent live (attenuated) vaccine within 2 months before the first treatment visit.
* Recent major surgery (within 4 weeks of screening) or planned major surgery during the study.
* The participant has received medications/treatments for MS within a specified time frame.
* Receiving potent and moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
* Receiving anticoagulant or antiplatelet therapy (such as aspirin>81mg/day, clopidogrel, warfarin).
* Contraindications to magnetic resonance imaging (MRI).
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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/08/2024
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Sample size
Target
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Accrual to date
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Final
1131
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360007 - St Leonards
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Recruitment hospital [2]
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Investigational Site Number :0360003 - Woolloongabba
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Recruitment hospital [3]
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Investigational Site Number :0360002 - Kent Town
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Recruitment hospital [4]
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Investigational Site Number :0360004 - Hobart
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Recruitment hospital [5]
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Investigational Site Number :0360001 - Fitzroy
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Recruitment hospital [6]
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Investigational Site Number :0360006 - Heidelberg West
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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- Kent Town
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Recruitment postcode(s) [4]
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7001 - Hobart
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3081 - Heidelberg West
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Florida
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Georgia
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Illinois
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Kansas
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Kentucky
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Massachusetts
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Michigan
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Bruxelles
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Belgium
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Edegem
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Gent
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Liège
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Mons
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Canada
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Ontario
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Beijing
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Changchun
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China
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Changsha
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Chengdu
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Chongqing
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China
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Fuzhou
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China
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Guangzhou
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Hangzhou
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Shijiazhuang
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China
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Taiyuan
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China
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Xi'an
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Brno
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Bron
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Matosinhos
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Porto
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Russian Federation
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Perm
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Smolensk
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Tyumen
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Ufa
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Devon
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
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Trial website
https://clinicaltrials.gov/study/NCT04411641
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
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Address
0
0
Sanofi
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
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0
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0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/41/NCT04411641/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/41/NCT04411641/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04411641
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