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SAR441566

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

Ensayo de Sanofi en Psoriasis.

Más ensayos de: Psoriasis.

Fase

Fase 1

Estado

Completado

Participantes

38

previstos

Centros

1

Fin del objetivo primario

feb 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en jul 2022.

Qué mide

Number of participants with treatment-emergent adverse events (TEAE) including SAE and AESI (del registro, en inglés) (hasta 69 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05453942), actualizada en sep 2025.