NCT06073119

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details included a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (4 weeks ± 3 days). The total number of study visits was 7.

Detailed description

The overall study duration for each participant was up to 149 days.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	SAR441566	Tablet
DRUG	Placebo	Tablet

Timeline

• Start date: 2023-10-26
• Primary completion: 2024-11-13
• Completion: 2024-12-11
• First posted: 2023-10-10
• Last updated: 2025-11-10
• Results posted: 2025-11-10

Locations

51 sites across 17 countries: United States, Argentina, Bulgaria, Canada, Chile, China, Czechia, Georgia, Germany, Hungary, Japan, Mauritius, Poland, Portugal, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study