Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06824103
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Graft vs. Host Disease
  • Corticosteroid-refractory Chronic Graft vs. Host Disease
  • Graft vs. Host Disease

Eligibility Criteria

Sex
ALL
Age
12 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib is taken orally daily at 10 mg BID, given as two 5 mg tablets.

Study Details

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).

Key Dates

Start date
Sep 9, 2025
Status verified
Jun 2026
Primary completion
May 10, 2029
Completion
May 23, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    Chinese participants (adult and pediatric) who will receive ruxolitinib daily.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Cycle 7 Day 1; each Cycle =28 days ]

Central Contacts

Related Studies