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NCT04781816

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
Sanofi·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Cutaneous Lupus Erythematosus
Drug/Device/Intervention
SAR443122
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sanofi
Location
Cooper City,Charlotte,Columbus,Caba,Caba,Caba,Rosario,Mendoza,Camberwell,East Melbourne,London,Toronto,Sherbrooke,Valdivia,Osorno,Santiago,Santiago,Santiago,Santiago,Brno,Nachod,Pardubice,Praha 6,Buda, Argentina,Australia,Canada,Chile,Czech,Hungary,India,Italy,Mexico,Poland,Russian Federation,Spain,Uk
Timeline & enrollment
Phase
Phase 2
Start date
Apr 01, 2021
End date
Dec 26, 2022
Enrollment
88 participants
Primary outcome

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

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

ICD-10 classifications
Subacute cutaneous lupus erythematosusLupus erythematosusDiscoid lupus erythematosusSystemic lupus erythematosusSystemic lupus erythematosus, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04781816
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04781816 through Pure Global AI's free database. This Phase 2 trial is sponsored by Sanofi and is currently Recruiting. The study focuses on Cutaneous Lupus Erythematosus. Target enrollment is 88 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.