Trials / Recruiting
RecruitingNCT06585774
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INCA034176 | IV infusion |
| DRUG | Placebo | IV infusion |
| DRUG | Corticosteroids | Oral/IV Infusion |
Timeline
- Start date
- 2025-01-21
- Primary completion
- 2027-09-28
- Completion
- 2030-03-31
- First posted
- 2024-09-19
- Last updated
- 2026-04-06
Locations
118 sites across 13 countries: United States, Australia, Austria, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06585774. Inclusion in this directory is not an endorsement.