NCT06462469

Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease

A Single-arm, Multi-center Study of Ruxolitinib for the Treatment of Chinese Patients With Grade II-IV Corticosteroid-refractory Acute Graft Versus Host Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).

Detailed description

Participants will start with a screening period to assess the eligibility; only participants who meet all the inclusion and none of the exclusion criteria will start study treatment from Day 1 to Week 24 or end of treatment. Following safety follow up visits, participants will receive the long-term follow-up until Month 12.

Conditions

• Steroid-refractory Acute Graft Versus 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: 2024-07-04
• Primary completion: 2027-01-04
• Completion: 2028-02-17
• First posted: 2024-06-17
• Last updated: 2025-11-25

Locations

17 sites across 1 country: China