Trials / Recruiting
RecruitingNCT06824103
Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
A Single-arm Multi-center Study of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years – 100 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Graft vs. Host Disease
- Chronic Graft vs. Host Disease
- Corticosteroid-refractory Chronic Graft vs. Host Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ruxolitinib | Ruxolitinib is taken orally daily at 10 mg BID, given as two 5 mg tablets. |
Timeline
- Start date
- 2025-09-09
- Primary completion
- 2029-11-29
- Completion
- 2032-01-11
- First posted
- 2025-02-13
- Last updated
- 2025-11-26
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06824103. Inclusion in this directory is not an endorsement.