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
← catalyst calendarNCT06821542 · readout in 650 d
Sponsored by Incyte Corporation (industry) · INCY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
9actual
Sites
130
Countries
Austria, Belgium, Czechia +13
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 | 2025-06-04 | actual | When the study began enrolling |
| Primary completion | 2028-05-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-11-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-02-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-23 | 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 Therapy (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, • Pentostatin, • Proteasome inhibitors, • Imatinib, • 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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