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

Sponsor
Sanofi
Study ID
NCT05453942
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 12, 2022
Start date
Jul 12, 2022
Status verified
Sep 2025
Primary completion
Feb 9, 2023
Completion
Feb 9, 2023

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAR441566
    Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions
  • Placebo Comparator: Placebo
    Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAE) including SAE and AESI [ Time Frame: Up to 69 days ]

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