- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04781816
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus (CLEan)
June 26, 2023 updated by: Sanofi
Randomized, Double-blind, Placebo Controlled, Proof of Concept Study Assessing the Efficacy and Safety of the RIPK1-inhibitor SAR443122 in Patients With Moderate to Severe Subacute or Discoid/Chronic Cutaneous Lupus Erythematosus
Primary Objective:
- Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE)
Secondary Objectives:
- Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity)
- Assess the effect of SAR443122 on CLE induced itch and overall pain
- Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo
- Assess the effect of SAR443122 on the CLASI components score
- Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE)
- Assess oral cavities for patients with oral lesions
- Assess the disease specific quality of life (QoL)
- Assess the safety and tolerability of SAR443122 in patients with CLE
- Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Total study duration per participant will be up 20 weeks including:
- A screening period of up to 4 weeks
- A treatment period of 12 weeks
- A post treatment follow-up period of 4 weeks
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mendoza, Argentina, M5500
- Investigational Site Number :0320005
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Buenos Aires
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Caba, Buenos Aires, Argentina, C1023AAB
- Investigational Site Number :0320002
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Caba, Buenos Aires, Argentina, C1055AAO
- Investigational Site Number :0320003
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Caba, Buenos Aires, Argentina, C1111
- Investigational Site Number :0320001
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DBS
- Investigational Site Number :0320004
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Victoria
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Camberwell, Victoria, Australia, 3124
- Investigational Site Number :0360001
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East Melbourne, Victoria, Australia, 3002
- Investigational Site Number :0360002
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Ontario
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London, Ontario, Canada, N6A2C2
- Investigational Site Number :1240001
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Toronto, Ontario, Canada, M4W2N2
- Investigational Site Number :1240005
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Quebec
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Sherbrooke, Quebec, Canada, J1L 0H8
- Investigational Site Number :1240002
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Los Ríos
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Valdivia, Los Ríos, Chile, 5110683
- Investigational Site Number :1520009
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Reg Metropolitana De Santiago
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Osorno, Reg Metropolitana De Santiago, Chile, 5311523
- Investigational Site Number :1520006
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Santiago, Reg Metropolitana De Santiago, Chile, 7580206
- Investigational Site Number :1520003
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Santiago, Reg Metropolitana De Santiago, Chile, 7640881
- Investigational Site Number :1520001
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Santiago, Reg Metropolitana De Santiago, Chile, 7500010
- Investigational Site Number :1520007
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Santiago, Reg Metropolitana De Santiago, Chile
- Investigational Site Number :1520002
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Brno, Czechia, 65691
- Investigational Site Number :2030002
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Nachod, Czechia, 547 01
- Investigational Site Number :2030004
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Pardubice, Czechia, 53002
- Investigational Site Number :2030006
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Praha 6, Czechia, 160 00
- Investigational Site Number :2030005
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Budapest, Hungary, 1085
- Investigational Site Number :3480001
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Szeged, Hungary, 6720
- Investigational Site Number :3480002
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India, India
- Investigational Site Number :3560002
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Nagpur, India, 440019
- Investigational Site Number :3560003
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Nashik, India, 422101
- Investigational Site Number :3560004
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Secunderabad, India, 500 003
- Investigational Site Number :3560001
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Genova, Italy, 16132
- Investigational Site Number :3800001
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Milano, Italy, 20122
- Investigational Site Number :3800002
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Benito Juarez, Mexico, 03100
- Investigational Site Number :4840003
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Chihuahua, Mexico, 31000
- Investigational Site Number :4840004
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Veracruz, Mexico, 91910
- Investigational Site Number :4840002
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Investigational Site Number :4840001
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Lubelskie
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Lublin, Lubelskie, Poland, 20-081
- Investigational Site Number :6160004
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Malopolskie
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Krakow, Malopolskie, Poland, 30-033
- Investigational Site Number :6160006
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Pomorskie
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Gdansk, Pomorskie, Poland, 80-214
- Investigational Site Number :6160002
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Slaskie
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Katowice, Slaskie, Poland, 40-611
- Investigational Site Number :6160007
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Krasnodar, Russian Federation, 350020
- Investigational Site Number :6430004
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Moscow, Russian Federation, 115419
- Investigational Site Number :6430005
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Moscow, Russian Federation, 125993
- Investigational Site Number :6430002
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St-Petersburg, Russian Federation, 197022
- Investigational Site Number :6430001
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Stavropol, Russian Federation, 355020
- Investigational Site Number :6430003
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Barcelona, Spain, 08036
- Investigational Site Number :7240006
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Barcelona [Barcelona]
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Barcelona, Barcelona [Barcelona], Spain, 08035
- Investigational Site Number :7240002
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Barcelona, Barcelona [Barcelona], Spain, 08041
- Investigational Site Number :7240007
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Catalunya [Cataluña]
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Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08907
- Investigational Site Number :7240001
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Madrid, Comunidad De
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Madrid, Madrid, Comunidad De, Spain, 28046
- Investigational Site Number :7240004
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Ivano-Frankivsk, Ukraine, 76018
- Investigational Site Number :8040001
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Kyiv, Ukraine, 04209
- Investigational Site Number :8040002
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London, United Kingdom, N195NF
- Investigational Site Number :8260002
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London, City Of
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London, London, City Of, United Kingdom, E11 1NR
- Investigational Site Number :8260003
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California
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Thousand Oaks, California, United States, 91360
- Millennium Clinical Trials-Site Number:8400001
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Florida
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Cooper City, Florida, United States, 33024
- GNP Research-Site Number:8400008
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North Carolina
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Charlotte, North Carolina, United States, 28211
- DJL Clinical Research, PLLC-Site Number:8400003
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Ohio
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Columbus, Ohio, United States, 43213
- ClinOhio Research Services-Site Number:8400007
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Texas
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Houston, Texas, United States, 77054
- Prolato Clinical Research Center-Site Number:8400010
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria :
- Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening.
- Participants with histologically confirmed and documented diagnosis within one year prior to Screening or during Screening period prior to randomization.
- Active cutaneous lupus erythematosus skin lesions and a Cutaneous Erythematosus.
- Disease Area and Severity Index activity (CLASI-A) ≥10 both at Screening and Baseline.
- Participant who is candidate for systemic treatment per Investigator's judgement.
Exclusion criteria:
- Systemic lupus erythematosus according to the 2012 SLICC criteria with major organ involvement.
- Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
- Autoimmune disease(s) other than systemic lupus erythematosus.
- Active skin diseases that may interfere with the study or study assessments.
- Exclusion related to tuberculosis, non-tuberculous mycobacterial infections, HIV, HBV, HCV, Herpes zoster, COVID-19 and other recurrent or recent serious infections.
- Prolonged QTcF ≥ 450 ms (by Fridericia formula) or clinically significant findings on electrocardiogram (ECG).
- Cannot avoid excessive UV exposure 4 weeks prior to baseline and during the study. Routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study.
- Concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit.
- Initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to Screening visit (or during Screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine.
- Systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication.
- Systemic corticosteroids treatment <4 weeks before baseline visit.
- Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study.
- Laboratory abnormalities at the Screening visit.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Matching placebo
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Pharmaceutical form: Capsule Route of administration: Oral
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Experimental: SAR443122
SAR443122 for 12 weeks
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Pharmaceutical form: Capsule Route of administration: Oral
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score
Time Frame: Baseline to Week 12
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The Cutaneous Erythematosus Disease Area and Severity Index (CLASI) is a clinician rated scale composed of 56 items designed to assess the disease activity and damage in CLE in adults.
The disease activity (CLASI-A) sub-score ranges from 0 to 70: 0-9 indicating mild disease, 10-20 indicating moderate disease, and 21-70 indicating severe disease.
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Baseline to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of patients with physician's global assessment of disease activity (PhysGA - disease activity) of 0 or 1 (disease free or almost disease free)
Time Frame: Week 12
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The PhysGA-disease activity is a 5 point-Lickert scale instrument designed to assess physician-reported disease activity ranging from "Not active at all" to "Extremely active".
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Week 12
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Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS)
Time Frame: Baseline to Week 12
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The itch-NRS is a single item patient-reported outcome (PRO) tool that patients will use to report the intensity of their pruritus (itch) during a daily recall period.
Patients will be asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS.
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Baseline to Week 12
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Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS)
Time Frame: Baseline to Week 12
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The Pain-NRS is a single item PRO tool that patients will use to report the intensity of their CLE-related pain (skin, oral, genital) during a daily recall period.
Patients will be asked to rate their worst pain on a 0 ("No pain") to 10 ("Worst pain imaginable") NRS.
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Baseline to Week 12
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Proportion of CLASI-A50 and CLASI-A75 responders
Time Frame: Week 12
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The CLASI-A50/75 response is defined as a patient achieved a decrease by at least 50%/75% of CLASI-A sub-score from baseline.
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Week 12
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Change from baseline in CLASI components' score
Time Frame: Baseline up to Week 12
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Change from baseline in CLASI components' score over time
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Baseline up to Week 12
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Proportion of patients with the Investigator's global assessment for CLE (IGA-CLE) score of 0 or 1 (clear or almost clear)
Time Frame: Week 12
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The IGA-CLE is a clinician reported outcome that allows for clinicians to assess the overall disease activity of CLE using a 5-point scale from 0 (clear) to 4 (severe).
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Week 12
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Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline
Time Frame: Baseline to Week 12
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OHIP-14 is a PRO questionnaire measures people's perception of dysfunction, discomfort and disability attributed to oral conditions in adults.
It is composed of 14 items that assess seven different dimensions.
The OHIP-14 scores can range from 0 to 56 and higher OHIP-14 scores indicate worse oral-health-related quality of life.
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Baseline to Week 12
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Change from baseline in SKINDEX-29+3 total score
Time Frame: Baseline to Week 12
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Skindex-29 is a PRO measure designed to assess the effects of skin disease on patients' health-related quality of life in adults.
It contains 29 items, distributed across 3 domains.
Individual items are scored from 0 to100 in 25-point increments with 100 representing maximal disability.
The Skindex 29+3 includes a fourth subscale (3 questions) to assess lupus-specific issues.
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Baseline to Week 12
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Total number of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time Frame: Screening up to end of study (Week 16)
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Screening up to end of study (Week 16)
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Percent of TEAEs, SAEs and AESIs
Time Frame: Screening up to end of study (Week 16)
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Screening up to end of study (Week 16)
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Percent of potentially clinically significant abnormalities (PCSAs)
Time Frame: Screening up to end of study (Week 16)
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Percent of potentially clinically significant abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG) or vital signs through end of study
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Screening up to end of study (Week 16)
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SAR443122 plasma concentration
Time Frame: Day 1, Day 57 and Day 85
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Day 1, Day 57 and Day 85
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Assessment of pharmacokinetic (PK) parameter: Cmax
Time Frame: Day 1, Day 57 and Day 85
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Maximum plasma concentration
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Day 1, Day 57 and Day 85
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Assessment of PK parameter: tmax
Time Frame: Day 1, Day 57 and Day 85
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Time to reach Cmax
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Day 1, Day 57 and Day 85
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Assessment of PK parameter: AUC0-tau
Time Frame: Day 1, Day 57 and Day 85
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Area under the plasma concentration - time curve over the dosing interval
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Day 1, Day 57 and Day 85
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Assessment of PK parameter: t1/2z
Time Frame: Day 1, Day 57 and Day 85
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Elimination half-life
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Day 1, Day 57 and Day 85
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
May 25, 2023
Study Completion (Actual)
June 26, 2023
Study Registration Dates
First Submitted
February 28, 2021
First Submitted That Met QC Criteria
February 28, 2021
First Posted (Actual)
March 4, 2021
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 26, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT16404
- 2020-004703-14 (EudraCT Number)
- U1111-1246-6784 (Registry Identifier: ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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