Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Status:
Recruiting
Trial end date:
2022-05-12
Target enrollment:
Participant gender:
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