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
NCT06263478 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-01-07
Summary
This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD).
Conditions
- Chronic Graft-versus-host-disease
Interventions
- DRUG
-
INCA034176
IV infusion
Sponsors & Collaborators
-
Incyte Biosciences Japan GK
lead INDUSTRY
Principal Investigators
-
Incyte Medical Monitor · Incyte Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-30
- Primary Completion
- 2025-08-06
- Completion
- 2027-03-30
- FDA Drug
- Yes
Countries
- Japan
Study Locations
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