INCA034176

DRUG5 trials

Sponsors

Incyte Biosciences Japan GK, Incyte Corporation

Conditions

Chronic Graft-versus-host-disease

Phase 1

A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD

RecruitingNCT06843408

Incyte CorporationChronic Graft-versus-host-disease

Start: 2025-06-25End: 2027-12-31Target: 30Updated: 2026-02-03

Phase 2

A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

RecruitingNCT07124078

Incyte CorporationChronic Graft-versus-host-disease

Start: 2026-03-31End: 2029-07-31Target: 60Updated: 2026-03-20

Phase 3

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease

Active, not recruitingNCT06263478

Incyte Biosciences Japan GKChronic Graft-versus-host-disease

Start: 2024-07-30End: 2027-03-30Updated: 2026-01-07

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

RecruitingNCT06585774

Incyte CorporationChronic Graft-versus-host-disease

Start: 2025-01-21End: 2030-03-31Target: 240Updated: 2026-03-16

A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

Active, not recruitingNCT06821542

Incyte CorporationChronic Graft-versus-host-disease

Start: 2025-06-04End: 2032-11-30Updated: 2026-03-23

Related Papers

Trial in progress: A phase 3, randomized, double-blind, placebo-controlled study of axatilimab and corticosteroids as initial treatment for moderate to severe chronic graft-versus-host disease

Blood2025-11-03

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Axatilimab in Healthy Japanese Male Participants: Results from a Phase 1, Randomized, Double-Blind, Dose-Escalation Study.

2025-05-171 citations