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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04781816
Other study ID # ACT16404
Secondary ID 2020-004703-14U1
Status Completed
Phase Phase 2
First received
Last updated
Start date April 1, 2021
Est. completion date June 26, 2023

Study information

Verified date June 2023
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date June 26, 2023
Est. primary completion date May 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Drug:
SAR443122
Pharmaceutical form: Capsule Route of administration: Oral
Placebo
Pharmaceutical form: Capsule Route of administration: Oral

Locations

Country Name City State
Argentina Investigational Site Number :0320001 Caba Buenos Aires
Argentina Investigational Site Number :0320002 Caba Buenos Aires
Argentina Investigational Site Number :0320003 Caba Buenos Aires
Argentina Investigational Site Number :0320005 Mendoza
Argentina Investigational Site Number :0320004 Rosario Santa Fe
Australia Investigational Site Number :0360001 Camberwell Victoria
Australia Investigational Site Number :0360002 East Melbourne Victoria
Canada Investigational Site Number :1240001 London Ontario
Canada Investigational Site Number :1240002 Sherbrooke Quebec
Canada Investigational Site Number :1240005 Toronto Ontario
Chile Investigational Site Number :1520006 Osorno Reg Metropolitana De Santiago
Chile Investigational Site Number :1520001 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number :1520002 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number :1520003 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number :1520007 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number :1520009 Valdivia Los Ríos
Czechia Investigational Site Number :2030002 Brno
Czechia Investigational Site Number :2030004 Nachod
Czechia Investigational Site Number :2030006 Pardubice
Czechia Investigational Site Number :2030005 Praha 6
Hungary Investigational Site Number :3480001 Budapest
Hungary Investigational Site Number :3480002 Szeged
India Investigational Site Number :3560002 India
India Investigational Site Number :3560003 Nagpur
India Investigational Site Number :3560004 Nashik
India Investigational Site Number :3560001 Secunderabad
Italy Investigational Site Number :3800001 Genova
Italy Investigational Site Number :3800002 Milano
Mexico Investigational Site Number :4840003 Benito Juarez
Mexico Investigational Site Number :4840004 Chihuahua
Mexico Investigational Site Number :4840001 Monterrey Nuevo León
Mexico Investigational Site Number :4840002 Veracruz
Poland Investigational Site Number :6160002 Gdansk Pomorskie
Poland Investigational Site Number :6160007 Katowice Slaskie
Poland Investigational Site Number :6160006 Krakow Malopolskie
Poland Investigational Site Number :6160004 Lublin Lubelskie
Russian Federation Investigational Site Number :6430004 Krasnodar
Russian Federation Investigational Site Number :6430002 Moscow
Russian Federation Investigational Site Number :6430005 Moscow
Russian Federation Investigational Site Number :6430001 St-Petersburg
Russian Federation Investigational Site Number :6430003 Stavropol
Spain Investigational Site Number :7240002 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number :7240006 Barcelona
Spain Investigational Site Number :7240007 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number :7240001 Hospitalet de Llobregat Catalunya [Cataluña]
Spain Investigational Site Number :7240004 Madrid Madrid, Comunidad De
Ukraine Investigational Site Number :8040001 Ivano-Frankivsk
Ukraine Investigational Site Number :8040002 Kyiv
United Kingdom Investigational Site Number :8260002 London
United Kingdom Investigational Site Number :8260003 London London, City Of
United States DJL Clinical Research, PLLC-Site Number:8400003 Charlotte North Carolina
United States ClinOhio Research Services-Site Number:8400007 Columbus Ohio
United States GNP Research-Site Number:8400008 Cooper City Florida
United States Prolato Clinical Research Center-Site Number:8400010 Houston Texas
United States Millennium Clinical Trials-Site Number:8400001 Thousand Oaks California

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Czechia,  Hungary,  India,  Italy,  Mexico,  Poland,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to Week 12
Secondary 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". Week 12
Secondary 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. Baseline to Week 12
Secondary 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. Baseline to Week 12
Secondary 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. Week 12
Secondary Change from baseline in CLASI components' score Change from baseline in CLASI components' score over time Baseline up to Week 12
Secondary 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). Week 12
Secondary 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. Baseline to Week 12
Secondary 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. Baseline to Week 12
Secondary Total number of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) Screening up to end of study (Week 16)
Secondary Percent of TEAEs, SAEs and AESIs Screening up to end of study (Week 16)
Secondary 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 Screening up to end of study (Week 16)
Secondary SAR443122 plasma concentration Day 1, Day 57 and Day 85
Secondary Assessment of pharmacokinetic (PK) parameter: Cmax Maximum plasma concentration Day 1, Day 57 and Day 85
Secondary Assessment of PK parameter: tmax Time to reach Cmax Day 1, Day 57 and Day 85
Secondary Assessment of PK parameter: AUC0-tau Area under the plasma concentration - time curve over the dosing interval Day 1, Day 57 and Day 85
Secondary Assessment of PK parameter: t1/2z Elimination half-life Day 1, Day 57 and Day 85
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