Calendario›SNY›Belumosudil

Belumosudil

A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease

Ensayo de Sanofi en enfermedad crónica del injerto contra el hospedador.

Fase: Fase 3
Estado: Aún sin reclutar
Participantes: 356
Fin del objetivo primario: sep 2029

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2026.

Qué mide

tasa de respuesta global (en la semana 24)

Qué se prueba

Se prueba belumosudil frente a la terapia mejor disponible en pacientes con enfermedad injerto contra huésped crónica, con un período de tratamiento que continúa hasta que hay progresión clínicamente significativa, recaída, inicio de nuevo tratamiento sistémico u otro criterio de parada.

Lo que dice el documentobelumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation. The study will target patients post-ruxolitinib treatment, except where Investigators deemed ruxolitinib treatment for cGVHD not suitable. In the BAT arm, the study doctor will select one BAT based on clinical judgement, local availability etc. prior to randomization. Participants randomized to the BAT arm will have the option to cross-over to open-label belumosudil treatment upon meeting predefined criteria. Study details include: * The study duration will be defined as 3 years from LPI. * Individual participant duration on study will consist of: * Up to 28 days for screening. * Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD (except change from BAT to belumosudil during the cross-over), experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first. * Thirty days of post treatment safety follow-up. * Follow-up for cGVHD status as applicable. * Long-term follow-up until death or end of study, whichever occurs first.

Traducción automática (claude-haiku-4-5-20251001). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

Cómo lo describe el promotor

En el documentoEn inglés, del registroParticipants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation. The study will target patients post-ruxolitinib treatment, except where Investigators deemed ruxolitinib treatment for cGVHD not suitable. In the BAT arm, the study doctor will select one BAT based on clinical judgement, local availability etc. prior to randomization. Participants randomized to the BAT arm will have the option to cross-over to open-label belumosudil treatment upon meeting predefined criteria. Study details include: * The study duration will be defined as 3 years from LPI. * Individual participant duration on study will consist of: * Up to 28 days for screening. * Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD (except change from BAT to belumosudil during the cross-over), experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first. * Thirty days of post treatment safety follow-up. * Follow-up for cGVHD status as applicable. * Long-term follow-up until death or end of study, whichever occurs first.

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Ficha completa en ClinicalTrials.gov (NCT07771439), actualizada en sep 2026.