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Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT04781816•Sanofi

View on ClinicalTrials.gov

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 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

Eligibility

Age

18 - 80 years

Sex

ALL

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 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.
+4 more criteria

Locations (50)

GNP Research Site Number : 8400008

Cooper City, Florida, United States

DJL Clinical Research, PLLC Site Number : 8400003

Charlotte, North Carolina, United States

ClinOhio Research Services Site Number : 8400007

Columbus, Ohio, United States

Prolato Clinical Research Center Site Number : 8400010

Houston, Texas, United States

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320003

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320004

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320005

Mendoza, Argentina

Investigational Site Number : 0360001

Camberwell, Victoria, Australia

Key Dates

Start Date

April 1, 2021

Primary Completion Date

May 25, 2023

Completion Date

June 26, 2023

Last Updated

August 27, 2025

Enrollment

ACTUAL participants

Conditions

Cutaneous Lupus Erythematosus

Interventions

SAR443122

DRUG

Placebo

DRUG

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

NCT06875960

Systemic Lupus Erythematosus (SLE)Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

View study

TERMINATEDPHASE2

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

NCT05629208

Cutaneous Lupus Erythematosus (CLE)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

Study of M5049 in CLE and SLE Participants

Pilot Tape Harvesting Study