Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus (CLEan)

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: Cutaneous Lupus Erythematosus
• Intervention / Treatment: Drug: SAR443122; Drug: Placebo

Detailed Description

Total study duration per participant was 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

Study Locations

• Argentina
  • Mendoza, Argentina, M5500
    • Investigational Site Number : 0320005
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1023AAB
      • Investigational Site Number : 0320002
    • CABA, Buenos Aires, Argentina, C1055AAO
      • Investigational Site Number : 0320003
    • CABA, Buenos Aires, Argentina, C1111
      • Investigational Site Number : 0320001
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000DBS
      • Investigational Site Number : 0320004
• Australia
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Investigational Site Number : 0360001
    • East Melbourne, Victoria, Australia, 3002
      • Investigational Site Number : 0360002
• Canada
  • Ontario
    • London, Ontario, Canada, N6A2C2
      • Investigational Site Number : 1240001
    • Toronto, Ontario, Canada, M4W 2W4
      • Investigational Site Number : 1240005
  • Quebec
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Investigational Site Number : 1240002
• Chile
  • Los Ríos Region
    • Valdivia, Los Ríos Region, Chile, 5110683
      • Investigational Site Number : 1520009
  • Reg Metropolitana de Santiago
    • Osorno, Reg Metropolitana de Santiago, Chile, 5311523
      • Investigational Site Number : 1520006
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500010
      • Investigational Site Number : 1520007
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
      • Investigational Site Number : 1520002
• Czechia
  • Brno, Czechia, 65691
    • Investigational Site Number : 2030002
  • Náchod, Czechia, 547 01
    • Investigational Site Number : 2030004
  • Pardubice, Czechia, 53002
    • Investigational Site Number : 2030006
  • Prague, Czechia, 160 00
    • Investigational Site Number : 2030005
• Hungary
  • Budapest, Hungary, 1085
    • Investigational Site Number : 3480001
  • Szeged, Hungary, 6720
    • Investigational Site Number : 3480002
• India
  • Chandigarh, India, 160015
    • Investigational Site Number : 3560002
  • Nagpur, India, 440019
    • Investigational Site Number : 3560003
  • Nashik, India, 422101
    • Investigational Site Number : 3560004
• Italy
  • Genova, Italy, 16132
    • Investigational Site Number : 3800001
  • Milan, Italy, 20122
    • Investigational Site Number : 3800002
• Mexico
  • Benito Juárez, Mexico, 03100
    • Investigational Site Number : 4840003
  • Chihuahua City, Mexico, 31000
    • Investigational Site Number : 4840004
  • Monterrey, Nuevo León, Mexico, 64460
    • Investigational Site Number : 4840001
  • Veracruz, Mexico, 91910
    • Investigational Site Number : 4840002
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-033
      • Investigational Site Number : 6160006
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-081
      • Investigational Site Number : 6160004
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Investigational Site Number : 6160007
• Russia
  • Krasnodar, Russia, 350020
    • Investigational Site Number : 6430004
  • Moscow, Russia, 115419
    • Investigational Site Number : 6430005
  • Moscow, Russia, 125993
    • Investigational Site Number : 6430002
  • Saint Petersburg, Russia, 197022
    • Investigational Site Number : 6430001
  • Stavropol, Russia, 355020
    • Investigational Site Number : 6430003
• Spain
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Investigational Site Number : 7240002
    • Barcelona, Barcelona [Barcelona], Spain, 08041
      • Investigational Site Number : 7240007
    • L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain, 08907
      • Investigational Site Number : 7240001
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28046
      • Investigational Site Number : 7240004
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76018
    • Investigational Site Number : 8040001
  • Kyiv, Ukraine, 04209
    • Investigational Site Number : 8040002
• United Kingdom
  • London, City of
    • London, London, City of, United Kingdom, E11 1NR
      • Investigational Site Number : 8260003
• United States
  • Florida
    • Cooper City, Florida, United States, 33024
      • GNP Research Site Number : 8400008
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • DJL Clinical Research, PLLC Site Number : 8400003
  • Ohio
    • Columbus, Ohio, United States, 43213
      • ClinOhio Research Services Site Number : 8400007
  • Texas
    • Houston, Texas, United States, 77054
      • Prolato Clinical Research Center Site Number : 8400010

Participation Criteria

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 was 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 was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Pharmaceutical form: Capsule Route of administration: Oral
Experimental: SAR443122; SAR443122 for 12 weeks	Drug: SAR443122; Pharmaceutical form: Capsule Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12	The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.	Baseline (Day 1) and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12	The PhysGA- disease activity is a 5 point-Lickert scale instrument designed to assess physician-reported disease activity. The investigators were asked the following question "How active would you say your patient's cutaneous lupus erythematosus is currently?" The total score on scale ranges from 0 (not active at all) to 4 (extremely active). Higher score indicates a more severe skin disease.	Week 12
Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12	The Peak Pruritus NRS (itch-NRS) is a single item patient reported outcomes (PRO) tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". The total score on scale ranges from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates a more severe skin disease. Baseline was defined as the average of daily non-missing scores obtained during the week prior to Day 1.	Baseline (Day 1) and Week 12
Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12	The Peak Pain NRS (Pain-NRS) is a single item PRO tool that participants used to report the intensity of their CLE-related pain (skin, oral, genital) during a daily recall period. Participants were asked to rate their worst pain on a 0 (no pain) to 10 (worst pain imaginable) NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no pain' and 10 being the 'worst pain imaginable', how would you rate your pain at the worst moment due to your lupus during the previous 24 hours?". The total score on scale ranges from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates a more severe skin disease. Baseline was defined as the average of daily non-missing scores obtained during the week prior to Day 1.	Baseline (Day 1) and Week 12
Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12	The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. The CLASI-A50/75 responder was defined as a participant who achieved a decrease by at least 50%/75% of CLASI-A sub-score from baseline.	Week 12
Change From Baseline in CLASI Components' Score Over Time	The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering two dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. CLASI-D disease damage covers the domains: dyspigmentation, scarring/atrophy/panniculitis, and clinically judged scarring of the scalp (including scarring alopecia). Scale ranges 0 (absence of disease damage) to 56 (severe disease damage) using the parameters of dyspigmentation and scarring. For CLASI-A and CLASI-D, higher score indicates a more severe skin disease. Change from baseline in CLASI components' score are reported. Baseline was defined as the Day 1 assessment value.	Baseline (Day 1) and Weeks 4, 8, 12, and 16
Percentage of Participants With Investigator's Global Assessment of Cutaneous Lupus Erythematosus (IGA-CLE) Score of 0 or 1 (Clear Or Almost Clear) at Week 12	The IGA-CLE is a clinician reported outcome (ClinRO) that allows for clinicians to assess the overall disease activity of CLE using a 5-point scale: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). The severity of CLE is determined by descriptions of a combination of 3 plaque characteristics: erythema, scale, elevation. Erythema is the primary characteristic that influenced the rating, with other characteristics considered secondarily. Telangiectatic change is not considered in the rating. The assessment did not require the presence of all 4 characteristics, the severity was averaged over the observed characteristics. The total score on scale ranges from 0 to 4. Higher score indicates a more severe skin disease.	Week 12
Change From Baseline to Week 12 in the Oral Health Impact Profile 14-Item Version (OHIP-14) for Participants With Oral Lesions at Baseline	The OHIP-14 is a PRO questionnaire that is composed of 14 items that assess 7 different dimensions, considering the perception of the individual in relation to the impact of oral conditions in the physical, psychological and social well-being in the last month. Each of the 14 items has a set of possible answers distributed in a Likert scale (0 = never, 1 = hardly ever. 2 = occasionally 3 = fairly often, 4 = very often), which represents the frequency that the individual perceives the impact of oral health on 7 dimensions: functional limitation (2 items), physical pain (2 items), psychological discomfort (2 items), physical disability (2 items), psychological disability (2 items), social disability (2 items) and handicap (2 items). The OHIP-14 scores range from 0 to 56 and are calculated by summing the ordinal values for 14 items. Domain scores range from 0 to 8. Higher OHIP-14 scores indicate worse oral-health-related quality of life. Baseline was defined as Day 1 assessment value.	Baseline (Day 1) and Week 12
Change From Baseline in SKINDEX-29+3 Total Score at Week 12	Skindex 29+3 is a PRO measure designed to assess the effects of skin disease on participants' health-related quality of life in adults. It contains the following domains: emotions (10 items), symptoms (7 items), functioning (12 items), lupus-specific issues (3 questions), and 1 item about treatment that is not part of the total score. Recall period is during the past week. Each item is rated on a 5-point Likert scale (never, rarely, sometimes, often, all the time). These responses are then transformed to a linear scale ranging from 0 to 100 in 25-point increments, with 100 representing maximal disability. The total score is the average of participants' responses to items in a given domain, ranging from 0 to 100, where higher scores indicate a greater impact on the health-related quality of life. Baseline was defined as the Day 1 assessment value.	Baseline (Day 1) and Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)	An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as the adverse events that occurred from the time of the first IMP administration up to the end of study visit. Serious adverse events (SAE): Any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. An AESI: 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.	From first dose of study treatment (Day 1) up to end of study (Week 16)
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Hemoglobin (Hb) ≤ 115 grams per liter (g/L) (Male [M]) or ≤ 95 g/L (Female [F]), ≥ 185 g/L (M) or ≥ 165 g/L (F), decrease from baseline ≥ 20 g/L; Platelets <100 x 10^9 per liter (/L) or ≥ 700 x 10^9/L; Erythrocytes ≥ 6 x 10^12/L; Leukocytes < 3 x 10^9/L (Non-Black [NB]); < 2 x 10^9/L (Black[B]); or ≥ 16 x 10^9/L; Neutrophils < 1.5 x 10^9/L (NB); < 1 x 10^9/L (B); Lymphocytes > 4 x 10^9/L; Monocytes > 0.7 x 10^9/L; Basophils > 0.1 x 10^9/L; Eosinophils > 0.5 x 10^9/L or > upper limit of normal range (ULN) (if ULN ≥ 0.5 x 10^9/L).	From first dose of study treatment (Day 1) up to end of study (Week 16)
Number of Participants With PCSA in Clinical Chemistry	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Glucose ≤ 3.9 millimoles per liter (mmol/L) and < lower limit of normal range (LLN) or ≥ 11.1 mmol/L (unfasted); ≥ 7 mmol/L (fasted); Creatine Kinase > 3 ULN; Sodium ≤ 129 mmol/L or ≥ 160 mmol/L; Potassium < 3 mmol/L or ≥ 5.5 mmol/L; Creatinine ≥ 150 micromoles per liter (μmol/L) (Adults) or ≥ 30% change from baseline or ≥ 100% change from baseline; Creatinine Clearance ≥ 60 - < 90 milliliters per minute (mL/min) (mild decrease in glomerular filtration rate [GFR]) or ≥ 30 - < 60 mL/min (moderate decrease in GFR) or ≥ 15 - < 30 mL/min (severe decrease in GFR) or < 15 mL/min (end stage renal disease); Alanine Aminotransferase > 3 ULN or > 5 ULN; Aspartate Aminotransferase > 3 ULN or > 5 ULN; Alkaline Phosphatase > 1.5 ULN; Total Bilirubin > 1.5 ULN.	From first dose of study treatment (Day 1) up to end of study (Week 16)
Number of Participants With PCSA in Urinalysis	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: pH ≤ 4.6 or ≥ 8.	From first dose of study treatment (Day 1) up to end of study (Week 16)
Number of Participants With PCSA in Electrocardiogram (ECG)	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Heart Rate (HR) < 50 beats/min (bpm) or < 50 bpm and decrease from baseline ≥ 20 bpm or < 40 bpm or > 90 bpm; PR Interval > 200 milliseconds (msec) or > 200 msec and increase from baseline ≥ 25% or > 220 msec; QRS Interval > 110 msec or 110 msec and increase from baseline ≥ 25% or > 120 msec; QT Interval > 500 msec; corrected QT (QTc) Interval > 450 msec or > 480 msec or increase from baseline [30-60] msec or increase from baseline > 60 msec.	From first dose of study treatment (Day 1) up to end of study (Week 16)
Number of Participants With PCSA in Vital Signs	PCSA values were defined as abnormal values considered medically important by the Sponsor, according to predefined criteria/thresholds based on literature reviews and defined by the Sponsor. Criteria for PCSA: Diastolic Blood Pressure (DBP) ≤ 45 millimeters of mercury (mmHg) and decrease from baseline ≥ 10 mmHg or ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; Pulse Rate (PR) ≤ 50 bpm and decrease from baseline ≥ 20 bpm or ≥ 120 bpm and increase from baseline ≥ 20 bpm; Systolic Blood Pressure (SBP) ≤ 95 mmHg and decrease from baseline ≥ 20 mmHg or ≥ 160 mmHg and increase from baseline ≥ 20 mmHg; Weight ≥ 5% decrease from baseline or ≥ 5% increase from baseline.	From first dose of study treatment (Day 1) up to end of study (Week 16)
Maximum Plasma Concentration (Cmax) of SAR443122	Blood samples were collected at the specified timepoints. Cmax was assessed by a Bayesian analysis using the population PK model.	2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57
Time to Reach Maximum Plasma Concentration (Tmax) of SAR443122	Blood samples were collected at the specified timepoints. tmax was assessed by a Bayesian analysis using the population PK model.	2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122	Blood samples were collected at the specified timepoints. AUC0-12 was assessed by a Bayesian analysis using the population PK model.	2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57
Terminal Elimination Half-Life (t1/2z) of SAR443122	Blood samples were collected at the specified timepoints. t1/2z was assessed by a Bayesian analysis using the population PK model.	1 hour before morning dose and 2-5 hours post first morning dose on Day 85

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• ACT16404 Cutaneous Lupus Erythematosus website
• ACT16404 Plain Language Results Summary

Study record dates

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 (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• 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