Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT06824103
Brief Summary:
The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).
Detailed Description:
This is a single arm, multi-center, open label study which will enroll approximately 50 participants and investigate the efficacy and safety of ruxolitinib administered in adult and adolescent (≥12 years old) Chinese participants with SR-cGvHD.
The total duration on study for an individual participant will be up to 164 weeks (approximately 3 years).
The study consists of following periods, with each cycle comprised of 4 weeks (28 days):
* Screening Period (Day -28 to Day -1)
* Treatment period (Day 1 to Cycle 39/EOT)
* Safety follow-up (Last dose +30 days)
* Long-term survival follow-up period (EOT to 156 weeks on study).
Study:
NCT06824103
Study Brief:
Protocol Section:
NCT06824103