← Back to searchRecruitingRecruiting
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT06585774 · Incyte Corporation
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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).
Eligibility criteria
Inclusion Criteria:
* ≥ 12 years of age at the time of informed consent.
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
* Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Prior treatment with CSF-1R targeted therapies.
* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* Active symptomatic myositis.
* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.
* Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* Pregnant or breastfeeding.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study design
Enrollment target: 240 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2025-01-21
Estimated completion: 2030-03-31
Last updated: 2026-04-06
Interventions
Drug: INCA034176Drug: PlaceboDrug: Corticosteroids
Primary outcomes
- • Event Free Survival (EFS) (Up to 3 years)
Sponsor
Incyte Corporation · industry
Contacts & investigators
ContactIncyte Corporation Call Center (US) · contact · medinfo@incyte.com · 1.855.463.3463
ContactIncyte Corporation Call Center (ex-US) · contact · eumedinfo@incyte.com · +800 00027423
InvestigatorAlbert Assad, MD · study_director, Incyte Corporation
All locations (118)
University of Alabama BirminghamRecruiting
Birmingham, Alabama, United States
University of California San Diego Medical Center, Moores Cancer CenterRecruiting
La Jolla, California, United States
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
Childrens National HospitalRecruiting
Washington D.C., District of Columbia, United States
Miami Cancer InstituteRecruiting
Miami, Florida, United States
Orlando Health Cancer Institute Downtown OrlandoRecruiting
Orlando, Florida, United States
Memorial Cancer InstituteRecruiting
Pembroke Pines, Florida, United States
Emory University-Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
University of IllinoisRecruiting
Chicago, Illinois, United States
The University of Kansas Cancer CenterRecruiting
Kansas City, Kansas, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Corewell Health Hematology OncologyRecruiting
Grand Rapids, Michigan, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Rutgers Cancer Institute of NjRecruiting
New Brunswick, New Jersey, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
Stony Brook University Medical CenterRecruiting
Stony Brook, New York, United States
Wake Forest Baptist Medical CenterRecruiting
Winston-Salem, North Carolina, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Jefferson University HospitalsRecruiting
Philadelphia, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Prisma Health UpstateRecruiting
Greenville, South Carolina, United States
Baptist Cancer CenterRecruiting
Memphis, Tennessee, United States
St David'S South Austin Medical CenterRecruiting
Austin, Texas, United States
Texas Transplant InstituteRecruiting
San Antonio, Texas, United States
Intermountain Blood and Marrow TransplantRecruiting
Salt Lake City, Utah, United States
Virginia Commonwealth University Massey Cancer CenterRecruiting
Richmond, Virginia, United States
West Virginia University Cancer InstituteRecruiting
Morgantown, West Virginia, United States
Royal Prince Alfred HospitalRecruiting
Sydney, New South Wales, Australia
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Austin Health Medical Oncology and Clinical HaematologyRecruiting
Heidelberg, Victoria, Australia
Landeskrankenhaus Universitatsklinikum GrazRecruiting
Graz, Austria
Innsbruck University HospitalRecruiting
Innsbruck, Austria
Ordensklinikum Linz Gmbh ElisabethinenRecruiting
LINZ CET, Austria
Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin IRecruiting
Vienna, Austria
St. Anna Childrens HospitalRecruiting
Vienna, Austria
Alberta'S Children HospitalRecruiting
Calgary, Alberta, Canada
Stollery Children'S HospitalRecruiting
Edmonton, Alberta, Canada
Bc Children'S HospitalRecruiting
Vancouver, British Columbia, Canada
Queen Elizabeth Ii Health Sciences CentreRecruiting
Halifax, Nova Scotia, Canada
Juravinski Cancer CentreRecruiting
Hamilton, Ontario, Canada
Princess Margaret Cancer CenterRecruiting
Toronto, Ontario, Canada
Hospital Maisonneuve RosemontRecruiting
Montreal, Quebec, Canada
Vancouver General HospitalRecruiting
Vancouver, Canada
RigshospitaletRecruiting
Copenhagen, Denmark
Chu Amiens Picardie - Hopital SudRecruiting
Amiens, France
Institut Paoli CalmettesRecruiting
Marseille, France
Hopitaux de BraboisRecruiting
Nancy, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-DieuRecruiting
Nantes, France
Chu de Nice - Hospital L ArchetRecruiting
Nice, France
Hospital Saint LouisRecruiting
Paris, France
Hospital Saint AntoineRecruiting
Paris, France
Hospices Civils de Lyon Centre Hospitalier Lyon SudRecruiting
Pierre-Bénite, France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-OncopoleRecruiting
Toulouse, France
University Medical Center Rwth AachenRecruiting
Aachen, Germany
Charite Universitatsmedizin BerlinRecruiting
Berlin, Germany
Universitaetsklinikum Bonn, University Hospital BonnRecruiting
Bonn, Germany
University Clinic Carl Gustav Carus Technical University DresdenRecruiting
Dresden, Germany
University Hospital DuesseldorfRecruiting
Düsseldorf, Germany
Universitaetsklinikum ErlangenRecruiting
Erlangen, Germany
Universitatsklinikum EssenRecruiting
Essen, Germany
Universitatsklinikum Halle (Saale)Recruiting
Halle, Germany
University Hospital Schleswig-Holstein Campus KielRecruiting
Kiel, Germany
Universitatsklinikum LeipzigRecruiting
Leipzig, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz IiiRecruiting
Mainz, Germany
Klinikum Der Philipps-Universitaet MarburgRecruiting
Marburg, Germany
Universitatsklinikum MunsterRecruiting
Münster, Germany
St. James HospitalRecruiting
Dublin, Ireland
Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare ArrigoRecruiting
Alessandria, Italy
Azienda Ospedaliero Universitaria Delle MarcheRecruiting
Ancona, Italy
Asst Degli Spedali Civili Di BresciaRecruiting
Brescia, Italy
Irccs Azienda Ospedaliera Universitaria San MartinoRecruiting
Genova, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Ospedale San Raffaele - MilanoRecruiting
Milan, Italy
Azienda Ospedaliera Di Rilievo Nazionale Antonio CardarelliRecruiting
Naples, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloRecruiting
Palermo, Italy
Irccs Fondazione Policlinico San MatteoRecruiting
Pavia, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-MorelliRecruiting
Reggio Calabria, Italy
Azienda Policlinico Umberto 1 Universita Sapienza Di RomaRecruiting
Rome, Italy
Ospedale Pediatrico Bambino Gesu IrccsRecruiting
Rome, Italy
I.R.C.C.S. Casa Sollievo Della SofferenzaRecruiting
San Giovanni Rotondo, Italy
Azienda Ospedaliera Card. G. PanicoRecruiting
Tricase, Italy
Centro Ricerche Cliniche Di VeronaRecruiting
Verona, Italy
Anjo Kosei HospitalRecruiting
Aichi, Japan
Fujita Health University HospitalRecruiting
Aichi, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Hiroshima University HospitalRecruiting
Hiroshima, Japan
Kobe City Medical Center General HospitalRecruiting
Hyōgo, Japan
Tokai University HospitalRecruiting
Kanagawa, Japan
National Hospital Organization Kumamoto Medical CenterRecruiting
Kumamoto, Japan
Gunma Saiseikai Maebashi HospitalRecruiting
Maebashi, Japan
Tohoku University HospitalRecruiting
Miyagi, Japan
Okayama University HospitalRecruiting
Okayama Okayama, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Hokkaido University HospitalRecruiting
Sapporo Hokkaido, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalRecruiting
Tokyo, Japan
Amsterdam University Medical CentreRecruiting
Amsterdam, Netherlands
Maastricht University Medical CenterRecruiting
Maastricht, Netherlands
Hospital General Universitario Vall D HebronRecruiting
Barcelona, Spain
Hospital de La Santa Creu I Sant PauRecruiting
Barcelona, Spain
Hospital Universitario DonostiaRecruiting
Donostia / San Sebastian, Spain
Institut Catala Doncologia Ico - Hospital Duran I Reynals LocationRecruiting
L'Hospitalet de Llobregat, Spain
Hospital Universitario de Gran Canaria Doctor NegrinRecruiting
Las Palmas de Gran Canaria, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Hospital Puerta de HierroRecruiting
Majadahonda, Spain
Hospital Universitario Virgen Del RocioRecruiting
Seville, Spain
Hospital Universitari I Politecnic La FeRecruiting
Valencia, Spain
Hospital Universitario Miguel ServetRecruiting
Zaragoza, Spain
Bristol Haematology and Oncology CentreRecruiting
Bristol, United Kingdom
Queen Elizabeth University HospitalRecruiting
Glasgow, United Kingdom
Royal Marsden HospitalRecruiting
London, United Kingdom
University College London Hospitals (Uclh)Recruiting
London, United Kingdom
Manchester University Nhs Foundation TrustRecruiting
Manchester, United Kingdom
Nottingham University HospitalsRecruiting
Nottingham, United Kingdom
Plymouth Hospitals Nhs TrustRecruiting
Plymouth, United Kingdom