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

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

Timeline

Start

2021-04-01

Primary completion

2023-05-25

Completion

2023-06-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs SAR443122; Least Square Mean Difference -5.70 (90% CI -18.26 to 6.85) NCT04781816 ↗

Drugs

Indications