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

Primary Purpose

Cutaneous Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR443122
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Lupus Erythematosus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Millennium Clinical Trials-Site Number:8400001
  • GNP Research-Site Number:8400008
  • DJL Clinical Research, PLLC-Site Number:8400003
  • ClinOhio Research Services-Site Number:8400007
  • Prolato Clinical Research Center-Site Number:8400010
  • Investigational Site Number :0320002
  • Investigational Site Number :0320003
  • Investigational Site Number :0320001
  • Investigational Site Number :0320004
  • Investigational Site Number :0320005
  • Investigational Site Number :0360001
  • Investigational Site Number :0360002
  • Investigational Site Number :1240001
  • Investigational Site Number :1240005
  • Investigational Site Number :1240002
  • Investigational Site Number :1520009
  • Investigational Site Number :1520006
  • Investigational Site Number :1520007
  • Investigational Site Number :1520003
  • Investigational Site Number :1520001
  • Investigational Site Number :1520002
  • Investigational Site Number :2030002
  • Investigational Site Number :2030004
  • Investigational Site Number :2030006
  • Investigational Site Number :2030005
  • Investigational Site Number :3480001
  • Investigational Site Number :3480002
  • Investigational Site Number :3560002
  • Investigational Site Number :3560003
  • Investigational Site Number :3560004
  • Investigational Site Number :3560001
  • Investigational Site Number :3800001
  • Investigational Site Number :3800002
  • Investigational Site Number :4840001
  • Investigational Site Number :4840003
  • Investigational Site Number :4840004
  • Investigational Site Number :4840002
  • Investigational Site Number :6160004
  • Investigational Site Number :6160006
  • Investigational Site Number :6160002
  • Investigational Site Number :6160007
  • Investigational Site Number :6430004
  • Investigational Site Number :6430005
  • Investigational Site Number :6430002
  • Investigational Site Number :6430001
  • Investigational Site Number :6430003
  • Investigational Site Number :7240002
  • Investigational Site Number :7240007
  • Investigational Site Number :7240001
  • Investigational Site Number :7240004
  • Investigational Site Number :7240006
  • Investigational Site Number :8040001
  • Investigational Site Number :8040002
  • Investigational Site Number :8260003
  • Investigational Site Number :8260002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR443122

Placebo

Arm Description

SAR443122 for 12 weeks

Matching placebo

Outcomes

Primary Outcome Measures

Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score
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.

Secondary Outcome Measures

Proportion of patients with physician's global assessment of disease activity (PhysGA - disease activity) of 0 or 1 (disease free or almost disease free)
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".
Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS)
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.
Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS)
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.
Proportion of CLASI-A50 and CLASI-A75 responders
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.
Change from baseline in CLASI components' score
Change from baseline in CLASI components' score over time
Proportion of patients with the Investigator's global assessment for CLE (IGA-CLE) score of 0 or 1 (clear or almost clear)
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).
Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline
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.
Change from baseline in SKINDEX-29+3 total score
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.
Total number of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Percent of TEAEs, SAEs and AESIs
Percent of potentially clinically significant abnormalities (PCSAs)
Percent of potentially clinically significant abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG) or vital signs through end of study
SAR443122 plasma concentration
Assessment of pharmacokinetic (PK) parameter: Cmax
Maximum plasma concentration
Assessment of PK parameter: tmax
Time to reach Cmax
Assessment of PK parameter: AUC0-tau
Area under the plasma concentration - time curve over the dosing interval
Assessment of PK parameter: t1/2z
Elimination half-life

Full Information

First Posted
February 28, 2021
Last Updated
June 26, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT04781816
Brief Title
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Acronym
CLEan
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
June 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR443122
Arm Type
Experimental
Arm Description
SAR443122 for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
SAR443122
Intervention Description
Pharmaceutical form: Capsule Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Capsule Route of administration: Oral
Primary Outcome Measure Information:
Title
Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Proportion of patients with physician's global assessment of disease activity (PhysGA - disease activity) of 0 or 1 (disease free or almost disease free)
Description
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".
Time Frame
Week 12
Title
Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS)
Description
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.
Time Frame
Baseline to Week 12
Title
Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS)
Description
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.
Time Frame
Baseline to Week 12
Title
Proportion of CLASI-A50 and CLASI-A75 responders
Description
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.
Time Frame
Week 12
Title
Change from baseline in CLASI components' score
Description
Change from baseline in CLASI components' score over time
Time Frame
Baseline up to Week 12
Title
Proportion of patients with the Investigator's global assessment for CLE (IGA-CLE) score of 0 or 1 (clear or almost clear)
Description
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).
Time Frame
Week 12
Title
Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline
Description
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.
Time Frame
Baseline to Week 12
Title
Change from baseline in SKINDEX-29+3 total score
Description
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.
Time Frame
Baseline to Week 12
Title
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)
Title
Percent of TEAEs, SAEs and AESIs
Time Frame
Screening up to end of study (Week 16)
Title
Percent of potentially clinically significant abnormalities (PCSAs)
Description
Percent of potentially clinically significant abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG) or vital signs through end of study
Time Frame
Screening up to end of study (Week 16)
Title
SAR443122 plasma concentration
Time Frame
Day 1, Day 57 and Day 85
Title
Assessment of pharmacokinetic (PK) parameter: Cmax
Description
Maximum plasma concentration
Time Frame
Day 1, Day 57 and Day 85
Title
Assessment of PK parameter: tmax
Description
Time to reach Cmax
Time Frame
Day 1, Day 57 and Day 85
Title
Assessment of PK parameter: AUC0-tau
Description
Area under the plasma concentration - time curve over the dosing interval
Time Frame
Day 1, Day 57 and Day 85
Title
Assessment of PK parameter: t1/2z
Description
Elimination half-life
Time Frame
Day 1, Day 57 and Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Millennium Clinical Trials-Site Number:8400001
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
GNP Research-Site Number:8400008
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
DJL Clinical Research, PLLC-Site Number:8400003
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
ClinOhio Research Services-Site Number:8400007
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Prolato Clinical Research Center-Site Number:8400010
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Investigational Site Number :0320002
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Investigational Site Number :0320003
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1055AAO
Country
Argentina
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1111
Country
Argentina
Facility Name
Investigational Site Number :0320004
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Investigational Site Number :0320005
City
Mendoza
ZIP/Postal Code
M5500
Country
Argentina
Facility Name
Investigational Site Number :0360001
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Investigational Site Number :0360002
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Investigational Site Number :1240001
City
London
State/Province
Ontario
ZIP/Postal Code
N6A2C2
Country
Canada
Facility Name
Investigational Site Number :1240005
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W2N2
Country
Canada
Facility Name
Investigational Site Number :1240002
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Investigational Site Number :1520009
City
Valdivia
State/Province
Los Ríos
ZIP/Postal Code
5110683
Country
Chile
Facility Name
Investigational Site Number :1520006
City
Osorno
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
5311523
Country
Chile
Facility Name
Investigational Site Number :1520007
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500010
Country
Chile
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7580206
Country
Chile
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
Country
Chile
Facility Name
Investigational Site Number :2030002
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Investigational Site Number :2030004
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Investigational Site Number :2030006
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Investigational Site Number :2030005
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Investigational Site Number :3480001
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Investigational Site Number :3480002
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Investigational Site Number :3560002
City
India
Country
India
Facility Name
Investigational Site Number :3560003
City
Nagpur
ZIP/Postal Code
440019
Country
India
Facility Name
Investigational Site Number :3560004
City
Nashik
ZIP/Postal Code
422101
Country
India
Facility Name
Investigational Site Number :3560001
City
Secunderabad
ZIP/Postal Code
500 003
Country
India
Facility Name
Investigational Site Number :3800001
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site Number :3800002
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Investigational Site Number :4840001
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number :4840003
City
Benito Juarez
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Investigational Site Number :4840004
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Investigational Site Number :4840002
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Investigational Site Number :6160004
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Investigational Site Number :6160006
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Investigational Site Number :6160002
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Investigational Site Number :6160007
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Investigational Site Number :6430004
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
125993
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
Stavropol
ZIP/Postal Code
355020
Country
Russian Federation
Facility Name
Investigational Site Number :7240002
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240007
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08041
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Hospitalet de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number :7240006
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number :8040001
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Investigational Site Number :8260003
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Investigational Site Number :8260002
City
London
ZIP/Postal Code
N195NF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
https://www.sanofistudies.com/1QVB/
Description
ACT16404 Cutaneous Lupus Erythematosus website

Learn more about this trial

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

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