NCT05453942

A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Clinical Response After 4-week Oral Treatment With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel, Phase 1, single center, 2-arm, double-blind, randomized, placebo-controlled with a ratio 2 active: 1 placebo study for treatment of mild to moderate psoriasis participants. Approximately 36 participants (24 in the SAR441566 group and 12 in the placebo group) are to be enrolled to have a total of 33 evaluable participants (22 in the SAR441566 group and 11 in the placebo group). The objective of this study is primarily to evaluate the tolerability and safety and secondarily the clinical response over 4-week oral treatment with SAR441566 in participants with mild to moderate psoriasis. The clinical response is measured by the relative change from baseline in Total Lesion Severity Score (TLSS). The study comprises an up to 4-week screening period, a 4-week treatment period with SAR441566 or placebo. The end-of-study visit will be carried out 10 ±3 days after the last investigational medicinal product administration. The frequency of visits is once a week during the treatment period.

Detailed description

* Screening period: up to 4 weeks * Treatment: 4 weeks (from Day 1 to Day 28) * End-of-Study: between 7 to 13 days after the last IMP administration (from Day 35 to Day 41) Total study duration: 37 to 69 days maximum (approximately between 6 and 10 weeks)

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	SAR441566	Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions
DRUG	Placebo	Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition

Timeline

• Start date: 2022-07-12
• Primary completion: 2023-02-09
• Completion: 2023-02-09
• First posted: 2022-07-12
• Last updated: 2025-09-25

Locations

1 site across 1 country: Germany