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)
← catalyst calendarNCT07124078 · readout in 896 d
Sponsored by Incyte Corporation (industry) · INCY — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
60estimated
Sites
41
Countries
Belgium, Germany, Italy +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-20 | actual | When the study began enrolling |
| Primary completion | 2029-01-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-07-31 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Graft-versus-host-disease
Interventions
- Drug: INCA034176 — also filed as Axatilimab
- Drug: Best available Treatment (BAT) — also filed as BAT could include:, • Calcineurin inhibitor (cyclosporine or tacrolimus), • Extracorporeal photopheresis (ECP), • Mycophenolate mofetil (MMF), • A mammalian target of rapamycin (mTOR) inhibitor (everolimus or sirolimus), • Rituximab, • Imatinib, • Methotrexate, • Ibrutinib
Primary outcome
what the primary-completion date above is the date OFObjective Response (OR) at 6 months
measured 6 months
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