NCT06388564

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.

Conditions

• Chronic Graft-versus-host-disease

Interventions

Type	Name	Description
DRUG	Axatilimab	Axatilimab will be administered at protocol defined dose.
DRUG	Ruxolitinib	Ruxolitinib will be administered at protocol defined dose.
DRUG	Corticosteroids	Corticosteroids will be administered at protocol defined dose.

Timeline

• Start date: 2024-10-11
• Primary completion: 2027-06-01
• Completion: 2029-12-01
• First posted: 2024-04-29
• Last updated: 2026-03-23

Locations

70 sites across 7 countries: United States, Belgium, Canada, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study