drugset / Trial / NCT06682169

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

NCT06682169

Phase 3 Recruiting 182 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24.

Timeline

Start
2024-11-20
Primary completion
2029-10
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Imatinib Small molecule 100 mg Oral
Comparator Imatinib Small molecule 400 mg Oral
Comparator Methotrexate Small molecule 5 mg Oral
Comparator Methotrexate Small molecule 10 mg Oral
Comparator Mycophenolate Mofetil Small molecule
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Rovadicitinib Small molecule 10 mg Oral