A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy

Condition studied

Immune system diseases

Investigational medicinal product(s)

Every trial of Belumosudil, Ixazomib, Sirolimus and Imatinib across our registers →

Eligibility

Primary endpoint

Overall response rate

Endpoint detail

Time from the date of randomization to the date of start of new systemic treatment for cGVHD, relapse or recurrence of underlying disease, or death, whichever occurs first., Proportion of participants achieving at least 6-point reduction from baseline in the modified Lee cGVHD Symptom Scale score at Week 24., Proportion of participants who achieve an overall response (CR or PR) within up to 24 weeks and without the requirement of new systemic therapy as per NIH consensus response criteria (2014)., Proportion of participants who achieve an overall response (CR or PR) based on NIH consensus response criteria (2014) at any time until start of new systemic therapy for cGVHD., The time from first response of PR or CR until documented progression, new systemic treatment for cGVHD, or death, whichever occurs first., Time from randomization to the first response (either CR or PR) per NIH consensus response criteria (2014) for cGVHD., Time from the date of randomization to the date of starting a new systemic therapy for cGVHD., Proportion of participants who achieve CR or PR based on NIH consensus criteria (2014) at any time point in each involved organ and before the start of new systemic therapy for cGVHD., The time from the date of randomization to the date of death from any cause., Proportion of participants with >50% reduction from baseline in daily CS dose at Week 24., Proportion of participants with discontinuation of CS at Week 24., Proportion of participants with >50% reduction from baseline in daily CNI dose at Week 24., Proportion of participants with discontinuation of CNI at Week 24., Incidence of TEAEs, SAEs, and AESIs., The cumulative incidence of relapse or recurrence of the underlying disease at any time during the study., Belumosudil plasma concentrations., Change from baseline in SF-36v2 domain scores and composite Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.