Phase II Study of Rovadicitinib TQ05105 Tablets for Treating Moderate to Severe Chronic Graft-versus-Host Disease in Adults Aged 18 to 70

What this Trial Is About

This trial is investigating the use of TQ05105 Tablets in adults aged 18 to 70 with moderate to severe chronic graft-versus-host disease cGVHD following allogeneic hematopoietic stem cell transplantation. The study aims to evaluate the efficacy and safety of this oral medication, which targets inflammatory and fibrotic processes involved in cGVHD. The trial is open-label and multicenter, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and conducted as a Phase II clinical study. Participants receive TQ05105 Tablets twice daily in 28-day treatment cycles. The study measures responses up to 48 weeks, including treatment effectiveness and safety outcomes. The primary outcome is the objective response rate at 24 weeks. Secondary outcomes include duration of response, survival rates, incidence of relapse, and adverse events. The study does not involve placebo or blinding. During their participation, patients will be monitored regularly with assessments to track their response to treatment, side effects, and overall health status. Evaluations include laboratory tests and clinical examinations related to cGVHD severity and treatment impact. The total participation period extends up to 48 weeks or more, with ongoing observation for safety and survival measures. Participants will follow a stable medication regimen and adhere to contraceptive measures if applicable.

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease