Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus - Trial NCT04781816
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.
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Study Focus
Sponsor & Location
Sanofi
Timeline & Enrollment
Phase 2
Apr 01, 2021
Dec 26, 2022
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
Data Source
ClinicalTrials.gov
NCT04781816
Non-Device Trial