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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)
NCT07124078 · View on ClinicalTrials.gov ↗
Study Summary
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
Conditions Studied
Interventions
- DRUG INCA034176
- DRUG Best available Treatment (BAT)
Study Locations (20)
Other
- Hôpital Universitaire Des Enfants Reine Fabiola — Brussels
- Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert
- Charite Campus Virchow — Berlin
- Klinikum Der Johann Wolfgang Goethe-Universitaet — Frankfurt am Main
- Universitaetsklinikum Freiburg Zentrum Fuer Kinderheilkunde- Und Jugendmedizin Klinik Iv: Paediatris — Freiburg im Breisgau
- Universitaetsklinikum Hamburg-Eppendorf — Hamburg
- Medizinische Hochschule Hannover (Mhh) - Zentrum Fuer Kinderheilkunde Und Jugendmedizin - Klinik Fue — Hanover
- University Hospital Regensburg — Regensburg
- Irccs - Aou Di Bologna - Sant'Orsola Malpighi — Bologna
- Irccs Istituto G. Gaslini, Universita Di Genova — Genova
- Fondazione Irccs San Gerardo Dei Tintori — Monza
California
- City of Hope Medical Center — Duarte
- Lucile Packard Child Hospital End — Stanford
District of Columbia
- Childrens National Medical Center — Washington D.C.
Florida
- Adventhealth Pediatric Cellular Therapy and Blood and Marrow Transplant — Orlando
Georgia
- Childrens Healthcare of Atlanta — Atlanta
New York
- Memorial Sloan Kettering Cancer Center — New York
North Carolina
- Levine Cancer Institute — Charlotte
Pennsylvania
- Childrens Hospital of Pittsburgh — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-31 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07124078
The ClinicalTrials.gov registry entry for NCT07124078 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Graft-versus-host-disease appearing as the primary indexed condition, and to 2 interventions — of which INCA034176 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07124078 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07124078 about?
NCT07124078 is a clinical study titled "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)". This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
What is the current status of trial NCT07124078?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-03-31. Estimated completion is 2029-07-31.
What conditions does trial NCT07124078 study?
This clinical trial studies the following conditions: Chronic Graft-versus-host-disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07124078?
The interventions under investigation include: INCA034176 (DRUG), Best available Treatment (BAT) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07124078?
This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07124078 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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