Phase 3 Study Comparing Rovadicitinib to Standard Treatments for Moderate to Severe Chronic Graft-versus-Host Disease After Multiple Prior Therapies

What this Trial Is About

Researchers are evaluating the effects of rovadicitinib compared to other treatments chosen by doctors in people with moderate to severe chronic graft-versus-host disease cGVHD who have already tried two or more treatments. The study aims to see if rovadicitinib can improve the rate of disease response after 24 weeks. This is a phase III clinical trial conducted by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and involves participants aged 18 to 70 years who have undergone allogeneic hematopoietic stem cell transplantation and have moderate to severe cGVHD. Participants will receive either rovadicitinib, taken orally at 10 mg twice daily on an empty stomach with 28-day treatment cycles, or one of several comparator drugs including methotrexate, metoprolol ester, imatinib, or rituximab according to the study protocol. The comparator treatments include weekly or twice-weekly oral methotrexate, daily oral metoprolol ester, daily oral imatinib, or weekly intravenous rituximab for 4 weeks. The study is randomized and open label, meaning both participants and researchers know which treatment is given. During the study, participants will be monitored for their response to treatment at 24 weeks, including symptom improvement and survival rates over an average of 2 years. Researchers will assess multiple outcomes such as the duration of relief, failure-free survival, disease recurrence, mortality, changes in quality of life, and adverse events. Blood samples will be taken at specified times to measure drug levels. Participants will be followed regularly to track their health and treatment effects throughout the study duration.

Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease