Trials / Active Not Recruiting
Active Not RecruitingNCT06263478
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
A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease After at Least 2 Lines of Systemic Therapy
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Incyte Biosciences Japan GK · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INCA034176 | IV infusion |
Timeline
- Start date
- 2024-07-30
- Primary completion
- 2025-08-06
- Completion
- 2027-03-30
- First posted
- 2024-02-16
- Last updated
- 2026-01-07
Locations
16 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06263478. Inclusion in this directory is not an endorsement.