A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
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Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
296estimated
Sites
121
Countries
Australia, Belgium, Canada +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 | 2021-03-04 | actual | When the study began enrolling |
| Primary completion | 2023-04-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-01-14 | actual | When this record first appeared on the registry |
| Results posted | 2024-10-10 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-16 | 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
Intervention
- Drug: Axatilimab — also filed as Niktimvo, SNDX-6352
Primary outcome
what the primary-completion date above is the date OFOverall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD)
measured First 6 cycles (up to Cycle 7 Day 1; each cycle = 4 weeks)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-04-05 · 1.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-06-27 · 516 KB · SAP_001.pdf
Publications
- PMID 39704205 — linked by the registry
- PMID 39292927 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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