RecruitingPhase 2NCT07124078

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, Randomized, Open-Label Study of 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)

Sponsor

Incyte Corporation

Enrollment

60 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Graft Versus Host Disease

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Best available Treatment (BAT) and a drug called INCA034176 for people with chronic graft versus host disease. The study is currently recruiting participants at 41 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINCA034176

Axatilimab at the protocol-defined dose.

DRUGBest available Treatment (BAT)

Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Locations(41)

City of Hope Medical Center

Duarte, California, United States

Children'S Hospital Los Angeles Specialt

Los Angeles, California, United States

Lucile Packard Child Hospital End

Palo Alto, California, United States

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Adventhealth Pediatric Cellular Therapy and Blood and Marrow Transplant

Orlando, Florida, United States

Childrens Healthcare of Atlanta

Atlanta, Georgia, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke Cancer Center

Durham, North Carolina, United States

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, Belgium

Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

Charite Campus Virchow

Berlin, Germany

Klinikum Der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Germany

Universitaetsklinikum Freiburg Zentrum Fuer Kinderheilkunde- Und Jugendmedizin Klinik Iv: Paediatris

Freiburg im Breisgau, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover (Mhh) - Zentrum Fuer Kinderheilkunde Und Jugendmedizin - Klinik Fue

Hanover, Germany

University Hospital Regensburg

Regensburg, Germany

Irccs - Aou Di Bologna - Sant'Orsola Malpighi

Bologna, Italy

Irccs Istituto G. Gaslini, Universita Di Genova

Genova, Italy

Fondazione Irccs San Gerardo Dei Tintori

Monza, Italy

Azienda Ospedaliera Universitaria Di Padova

Padua, Italy

Fondazione Irccs Policlinico San Matteo Di Pavia Oncoematologia Pediatrica, Universita Di Pavia

Pavia, Italy

Irccs Ospedale Pediatrico Bambino Gesu

Rome, Italy

Hospital Universitario Vall D'Hebron

Barcelona, Spain

Hospital Sant Joan de Deu Barcelona - Children'S Hospital

Esplugues de Llobregat, Spain

Hospital Infantil Unversitario Nino Jesus

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Regional Universitario de Malaga- Hospital Materno Infantil

Málaga, Spain

Hospital Universitario Virgen de La Arrixaca

Murcia, Spain

Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev

Valencia, Spain

Birmingham Children'S Hospital - Birmingham Women'S and Children'S Nhs Foundation Trust

Birmingham, United Kingdom

Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust

Cambridge, United Kingdom

The Royal Hospital For Children - Glasgow Health Board

Glasgow, United Kingdom

Leeds Childrens Hospital

Leeds, United Kingdom

St Mary'S Hospital, Paddington - Imperial College Healthcare Nhs Trust

London, United Kingdom

Great Ormond Street Hospital Nhs Trust

London, United Kingdom

Royal Manchester Children'S Hospital - Manchester University Nhs Foundation Trust

Manchester, United Kingdom

Royal Victoria Infirmary - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle, United Kingdom

Sheffield Children'S Hospital - Sheffield Children'S Nhs Foundation Trust

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07124078

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