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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	SAR443122	Pharmaceutical form: Capsule Route of administration: Oral
DRUG	Placebo	Pharmaceutical form: Capsule Route of administration: Oral

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-05-25
• Completion: 2023-06-26
• First posted: 2021-03-04
• Last updated: 2025-08-27
• Results posted: 2024-06-24

Locations

50 sites across 15 countries: United States, Argentina, Australia, Canada, Chile, Czechia, Hungary, India, Italy, Mexico, Poland, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study