Calendario›SNY›Belumosudil

Belumosudil

KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Ensayo de Sanofi en System; Sclerosis · Diffuse Cutaneous Systemic Sclerosis (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

36

previstos

Centros

26

Fin del objetivo primario

ago 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2019.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision due to slow enrollment and strategic consideration; not driven by any safety concerns.».

Qué mide

DB Period: Number of Participants With Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) Score Greater Than or Equal to (>=) 60 Percent (%) at Week 24 (del registro, en inglés) (semana 24)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis randomized, placebo-controlled phase 2 study was seeking to evaluate the efficacy and safety of belumosudil (KD025) for the treatment of diffuse cutaneous systematic sclerosis. Enrolment was terminated earlier than planned for business reasons unrelated to safety. A total of 36 participants were enrolled and randomized into 3 groups to either receive orally administered belumosudil (200 milligrams \[mg\] once daily \[QD\] and 200 mg twice daily \[BID\]) or matched placebo in 1:1:1 ratio in the double-blind (DB) period of this study. Study drug dosing was for 52 weeks: double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the participants on belumosudil continued on the same belumosudil dose whereas the participants in the placebo group were re-randomized to one of the belumosudil doses in a 1:1 ratio.

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Ficha completa en ClinicalTrials.gov (NCT03919799), actualizada en ago 2023.