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NCT07124078 · ClinicalTrials.gov registry record · Phase 2

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)

A Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Incyte Corporation.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
20
Study locations

NCT07124078 is a Phase 2 study of Chronic Graft Versus Host Disease that is actively recruiting participants, run by Incyte Corporation. The registered enrollment target is 60 participants, below the 114-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT07124078, a Phase 2 study of Chronic Graft Versus Host Disease, is actively recruiting participants, sponsored by Incyte Corporation.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
20
Study locations

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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2026-03-31
Est. Completion 2029-07-31
Phase Phase 2

Sponsor

Incyte Corporation

239 total trials

What the Registry Record Tells You About NCT07124078

The ClinicalTrials.gov registry entry for NCT07124078 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 114-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (47% lower). The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.

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.

NCT07124078 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, District of Columbia.

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.

What interventions are being tested in trial NCT07124078?

The interventions under investigation include: INCA034176 (DRUG), Best available Treatment (BAT) (DRUG).

Who is sponsoring clinical trial NCT07124078?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.