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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04781816
Registration number
NCT04781816
Ethics application status
Date submitted
28/02/2021
Date registered
4/03/2021
Date last updated
28/06/2023
Titles & IDs
Public title
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
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Scientific title
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
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Secondary ID [1]
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2020-004703-14
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Secondary ID [2]
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ACT16404
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Universal Trial Number (UTN)
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Trial acronym
CLEan
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAR443122
Treatment: Drugs - Placebo
Experimental: SAR443122 - SAR443122 for 12 weeks
Placebo Comparator: Placebo - Matching placebo
Treatment: Drugs: SAR443122
Pharmaceutical form: Capsule Route of administration: Oral
Treatment: Drugs: Placebo
Pharmaceutical form: Capsule 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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Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score
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Assessment method [1]
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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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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [1]
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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)
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Assessment method [1]
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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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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS)
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Assessment method [2]
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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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Timepoint [2]
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Baseline to Week 12
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Secondary outcome [3]
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Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS)
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Assessment method [3]
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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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Timepoint [3]
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Baseline to Week 12
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Secondary outcome [4]
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Proportion of CLASI-A50 and CLASI-A75 responders
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Assessment method [4]
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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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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Change from baseline in CLASI components' score
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Assessment method [5]
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Change from baseline in CLASI components' score over time
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Timepoint [5]
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Baseline up to Week 12
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Secondary outcome [6]
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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)
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Assessment method [6]
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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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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline
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Assessment method [7]
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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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Timepoint [7]
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Baseline to Week 12
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Secondary outcome [8]
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Change from baseline in SKINDEX-29+3 total score
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Assessment method [8]
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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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Timepoint [8]
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Baseline to Week 12
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Secondary outcome [9]
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Total number of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
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Assessment method [9]
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Timepoint [9]
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Screening up to end of study (Week 16)
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Secondary outcome [10]
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Percent of TEAEs, SAEs and AESIs
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Assessment method [10]
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Timepoint [10]
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Screening up to end of study (Week 16)
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Secondary outcome [11]
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Percent of potentially clinically significant abnormalities (PCSAs)
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Assessment method [11]
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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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Timepoint [11]
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Screening up to end of study (Week 16)
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Secondary outcome [12]
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SAR443122 plasma concentration
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Assessment method [12]
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Timepoint [12]
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Day 1, Day 57 and Day 85
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Secondary outcome [13]
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Assessment of pharmacokinetic (PK) parameter: Cmax
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Assessment method [13]
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Maximum plasma concentration
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Timepoint [13]
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Day 1, Day 57 and Day 85
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Secondary outcome [14]
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Assessment of PK parameter: tmax
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Assessment method [14]
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Time to reach Cmax
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Timepoint [14]
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Day 1, Day 57 and Day 85
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Secondary outcome [15]
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Assessment of PK parameter: AUC0-tau
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Assessment method [15]
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Area under the plasma concentration - time curve over the dosing interval
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Timepoint [15]
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Day 1, Day 57 and Day 85
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Secondary outcome [16]
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Assessment of PK parameter: t1/2z
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Assessment method [16]
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Elimination half-life
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Timepoint [16]
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Day 1, Day 57 and Day 85
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
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Maximum age
80
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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:
- 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.
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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 administering 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 2
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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
1/04/2021
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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
26/06/2023
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Sample size
Target
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Accrual to date
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Final
78
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Investigational Site Number :0360001 - Camberwell
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Recruitment hospital [2]
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Investigational Site Number :0360002 - East Melbourne
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Recruitment postcode(s) [1]
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3124 - Camberwell
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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United States of America
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North Carolina
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Ohio
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Mendoza
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Canada
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Ontario
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Canada
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Chile
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Los Ríos
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Chile
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Reg Metropolitana De Santiago
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Czechia
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Brno
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Czechia
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Nachod
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Czechia
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Pardubice
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Czechia
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Praha 6
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Hungary
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Budapest
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Hungary
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Szeged
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India
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India
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India
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Nagpur
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India
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Nashik
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India
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Secunderabad
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Italy
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Genova
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Italy
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Nuevo León
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Benito Juarez
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Mexico
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Chihuahua
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Mexico
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Veracruz
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Lubelskie
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Slaskie
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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St-Petersburg
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Russian Federation
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Stavropol
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Spain
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Barcelona [Barcelona]
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Spain
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Catalunya [Cataluña]
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Spain
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Madrid, Comunidad De
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Spain
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Barcelona
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kyiv
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United Kingdom
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London, City Of
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United Kingdom
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London
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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:
- 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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04781816
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04781816
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