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RECRUITING
NCT06585774
PHASE3

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

Summary

This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-01-21

Completion Date

2030-03-31

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

INCA034176

IV infusion

DRUG

Placebo

IV infusion

DRUG

Corticosteroids

Oral/IV Infusion

Locations (118)

University of Alabama Birmingham

Birmingham, Alabama, United States

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Childrens National Hospital

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

Miami Cancer Institute

Miami, Florida, United States

Orlando Health Cancer Institute Downtown Orlando

Orlando, Florida, United States

Memorial Cancer Institute

Pembroke Pines, Florida, United States

Emory University-Winship Cancer Institute

Atlanta, Georgia, United States

University of Illinois

Chicago, Illinois, United States

The University of Kansas Cancer Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health Hematology Oncology

Grand Rapids, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute of Nj

New Brunswick, New Jersey, United States

University of Rochester Medical Center

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Upstate

Greenville, South Carolina, United States

Baptist Cancer Center

Memphis, Tennessee, United States

St David'S South Austin Medical Center

Austin, Texas, United States

Texas Transplant Institute

San Antonio, Texas, United States

Intermountain Blood and Marrow Transplant

Salt Lake City, Utah, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

West Virginia University Cancer Institute

Morgantown, West Virginia, United States

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Austin Health Medical Oncology and Clinical Haematology

Heidelberg, Victoria, Australia

Landeskrankenhaus Universitatsklinikum Graz

Graz, Austria

Innsbruck University Hospital

Innsbruck, Austria

Ordensklinikum Linz Gmbh Elisabethinen

LINZ CET, Austria

Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin I

Vienna, Austria

St. Anna Childrens Hospital

Vienna, Austria

Alberta'S Children Hospital

Calgary, Alberta, Canada

Stollery Children'S Hospital

Edmonton, Alberta, Canada

Bc Children'S Hospital

Vancouver, British Columbia, Canada

Queen Elizabeth Ii Health Sciences Centre

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Hospital Maisonneuve Rosemont

Montreal, Quebec, Canada

Vancouver General Hospital

Vancouver, Canada

Rigshospitalet

Copenhagen, Denmark

Chu Amiens Picardie - Hopital Sud

Amiens, France

Institut Paoli Calmettes

Marseille, France

Hopitaux de Brabois

Nancy, France

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

Nantes, France

Chu de Nice - Hospital L Archet

Nice, France

Hospital Saint Louis

Paris, France

Hospital Saint Antoine

Paris, France

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, France

University Medical Center Rwth Aachen

Aachen, Germany

Charite Universitatsmedizin Berlin

Berlin, Germany

Universitaetsklinikum Bonn, University Hospital Bonn

Bonn, Germany

University Clinic Carl Gustav Carus Technical University Dresden

Dresden, Germany

University Hospital Duesseldorf

Düsseldorf, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Universitatsklinikum Essen

Essen, Germany

Universitatsklinikum Halle (Saale)

Halle, Germany

University Hospital Schleswig-Holstein Campus Kiel

Kiel, Germany

Universitatsklinikum Leipzig

Leipzig, Germany

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, Germany

Klinikum Der Philipps-Universitaet Marburg

Marburg, Germany

Universitatsklinikum Munster

Münster, Germany

St. James Hospital

Dublin, Ireland

Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo

Alessandria, Italy

Azienda Ospedaliero Universitaria Delle Marche

Ancona, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Italy

Irccs Azienda Ospedaliera Universitaria San Martino

Genova, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

Ospedale San Raffaele - Milano

Milan, Italy

Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli

Naples, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, Italy

Irccs Fondazione Policlinico San Matteo

Pavia, Italy

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

Reggio Calabria, Italy

Azienda Policlinico Umberto 1 Universita Sapienza Di Roma

Rome, Italy

Ospedale Pediatrico Bambino Gesu Irccs

Rome, Italy

I.R.C.C.S. Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy

Azienda Ospedaliera Card. G. Panico

Tricase, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

Anjo Kosei Hospital

Aichi, Japan

Fujita Health University Hospital

Aichi, Japan

Kyushu University Hospital

Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Japan

Kobe City Medical Center General Hospital

Hyōgo, Japan

Tokai University Hospital

Kanagawa, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Gunma Saiseikai Maebashi Hospital

Maebashi, Japan

Tohoku University Hospital

Miyagi, Japan

Okayama University Hospital

Okayama Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Hokkaido University Hospital

Sapporo Hokkaido, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, Japan

Amsterdam University Medical Centre

Amsterdam, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Hospital General Universitario Vall D Hebron

Barcelona, Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

L'Hospitalet de Llobregat, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Puerta de Hierro

Majadahonda, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari I Politecnic La Fe

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Royal Marsden Hospital

London, United Kingdom

University College London Hospitals (Uclh)

London, United Kingdom

Manchester University Nhs Foundation Trust

Manchester, United Kingdom

Nottingham University Hospitals

Nottingham, United Kingdom

Plymouth Hospitals Nhs Trust

Plymouth, United Kingdom