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

NCT05453942 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2023-02-09
Completion
2023-02-09

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05453942 on ClinicalTrials.gov