What this study is
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).
What's being tested
- INCA034176
Intervention · DRUG
- Placebo
Intervention · DRUG
- Corticosteroids
Intervention · DRUG
Oral/IV Infusion
Both INCA034176 and Placebo
IV infusion
Study details
- 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)
- Sponsor
- Incyte Corporation
- Conditions
- Chronic Graft-versus-host-disease
- Enrolling
- 240 people
- Starts
- 2025-01-21
- Est. completion
- 2030-03-31
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥ 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (131)
131 openUniversity of Alabama Birmingham
Birmingham, Alabama, United States
RecruitingUniversity of Arizona Cancer Center-Out Pt.
Tucson, Arizona, United States
RecruitingCity of Hope Medical Center
Duarte, California, United States
RecruitingUniversity of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
RecruitingUniversity of Southern California
Los Angeles, California, United States
RecruitingUCSF
San Francisco, California, United States
RecruitingColorado Blood Cancer Institute
Denver, Colorado, United States
RecruitingChildrens National Hospital
Washington D.C., District of Columbia, United States
RecruitingMiami Cancer Institute
Miami, Florida, United States
RecruitingOrlando Health Cancer Institute Downtown Orlando
Orlando, Florida, United States
RecruitingMemorial Cancer Institute
Pembroke Pines, Florida, United States
RecruitingEmory University-Winship Cancer Institute
Atlanta, Georgia, United States
RecruitingNorthwestern Memorial Hospital
Chicago, Illinois, United States
RecruitingUniversity of Illinois
Chicago, Illinois, United States
RecruitingThe University of Kansas Cancer Center
Kansas City, Kansas, United States
RecruitingJohn Hopkins Hospital
Baltimore, Maryland, United States
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
RecruitingDana Farber Cancer Institute
Boston, Massachusetts, United States
RecruitingUniversity of Michigan
Ann Arbor, Michigan, United States
RecruitingHenry Ford Hospital
Detroit, Michigan, United States
RecruitingCorewell Health Hematology Oncology
Grand Rapids, Michigan, United States
RecruitingHackensack University Medical Center
Hackensack, New Jersey, United States
RecruitingRutgers Cancer Institute of Nj
New Brunswick, New Jersey, United States
RecruitingUniversity of Rochester Medical Center
Rochester, New York, United States
RecruitingStony Brook University Medical Center
Stony Brook, New York, United States
RecruitingWake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
RecruitingOregon Health and Science University
Portland, Oregon, United States
RecruitingJefferson University Hospitals
Philadelphia, Pennsylvania, United States
RecruitingUpmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
RecruitingPrisma Health Upstate
Greenville, South Carolina, United States
RecruitingBaptist Cancer Center
Memphis, Tennessee, United States
RecruitingSt David'S South Austin Medical Center
Austin, Texas, United States
RecruitingTexas Transplant Institute
San Antonio, Texas, United States
RecruitingIntermountain Blood and Marrow Transplant
Salt Lake City, Utah, United States
RecruitingVirginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
RecruitingWest Virginia University Cancer Institute
Morgantown, West Virginia, United States
Recruiting
94 sites outside the US
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
RecruitingRoyal Adelaide Hospital
Adelaide, South Australia, Australia
RecruitingAustin Health Medical Oncology and Clinical Haematology
Heidelberg, Victoria, Australia
RecruitingLandeskrankenhaus Universitatsklinikum Graz
Graz, Austria
RecruitingInnsbruck University Hospital
Innsbruck, Austria
RecruitingOrdensklinikum Linz Gmbh Elisabethinen
LINZ CET, Austria
RecruitingAkh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin I
Vienna, Austria
RecruitingSt. Anna Childrens Hospital
Vienna, Austria
RecruitingAlberta'S Children Hospital
Calgary, Alberta, Canada
RecruitingStollery Children'S Hospital
Edmonton, Alberta, Canada
RecruitingBc Children'S Hospital
Vancouver, British Columbia, Canada
RecruitingQueen Elizabeth Ii Health Sciences Centre
Halifax, Nova Scotia, Canada
RecruitingJuravinski Cancer Centre
Hamilton, Ontario, Canada
RecruitingPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RecruitingHospital Maisonneuve Rosemont
Montreal, Quebec, Canada
RecruitingVancouver General Hospital
Vancouver, Canada
RecruitingRigshospitalet
Copenhagen, Denmark
RecruitingChu Amiens Picardie - Hopital Sud
Amiens, France
RecruitingInstitut Paoli Calmettes
Marseille, France
RecruitingHopitaux de Brabois
Nancy, France
RecruitingCentre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, France
RecruitingChu de Nice - Hospital L Archet
Nice, France
RecruitingHospital Saint Louis
Paris, France
RecruitingHospital Saint Antoine
Paris, France
RecruitingHospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, France
RecruitingUniversitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, France
RecruitingUniversity Medical Center Rwth Aachen
Aachen, Germany
RecruitingCharite Universitatsmedizin Berlin
Berlin, Germany
RecruitingUniversitaetsklinikum Bonn, University Hospital Bonn
Bonn, Germany
RecruitingUniversity Clinic Carl Gustav Carus Technical University Dresden
Dresden, Germany
RecruitingUniversity Hospital Duesseldorf
Düsseldorf, Germany
RecruitingUniversitaetsklinikum Erlangen
Erlangen, Germany
RecruitingUniversitatsklinikum Essen
Essen, Germany
RecruitingUniversitatsklinikum Halle (Saale)
Halle, Germany
RecruitingUniversitaetsklinikum Des Saarlandes
Homburg, Germany
RecruitingUniversity Hospital Schleswig-Holstein Campus Kiel
Kiel, Germany
RecruitingUniversitatsklinikum Leipzig
Leipzig, Germany
RecruitingUniversitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany
RecruitingKlinikum Der Philipps-Universitaet Marburg
Marburg, Germany
RecruitingUniversitatsklinikum Munster
Münster, Germany
RecruitingUniversity Hospital of Ulm, Universitatsklinikum Ulm
Ulm, Germany
RecruitingUniversitatsklinikum Wurzburg Medizinische Klinik Und Poliklinik Ii
Würzburg, Germany
RecruitingSt. James Hospital
Dublin, Ireland
RecruitingAzienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo
Alessandria, Italy
RecruitingAzienda Ospedaliero Universitaria Delle Marche
Ancona, Italy
RecruitingAou Policlinico Consorziale Di Bari
Bari, Italy
RecruitingAsst Degli Spedali Civili Di Brescia
Brescia, Italy
RecruitingAzienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
Catania, Italy
RecruitingIrccs Azienda Ospedaliera Universitaria San Martino
Genova, Italy
RecruitingAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
RecruitingOspedale San Raffaele - Milano
Milan, Italy
RecruitingAzienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
RecruitingAzienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, Italy
RecruitingIrccs Fondazione Policlinico San Matteo
Pavia, Italy
RecruitingGrande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
RecruitingAzienda Policlinico Umberto 1 Universita Sapienza Di Roma
Rome, Italy
RecruitingOspedale Pediatrico Bambino Gesu Irccs
Rome, Italy
RecruitingI.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
RecruitingAzienda Ospedaliera Card. G. Panico
Tricase, Italy
RecruitingCentro Ricerche Cliniche Di Verona
Verona, Italy
RecruitingFujita Health University Hospital
Aichi, Japan
RecruitingAnjo Kosei Hospital
Aichi-ken, Japan
RecruitingKyushu University Hospital
Fukuoka, Japan
RecruitingHiroshima University Hospital
Hiroshima, Japan
RecruitingKobe City Medical Center General Hospital
Hyōgo, Japan
RecruitingTokai University Hospital
Isehara Kanagawa, Japan
RecruitingNational Hospital Organization Kumamoto Medical Center
Kumamoto Kumamoto, Japan
RecruitingGunma Saiseikai Maebashi Hospital
Maebashi, Japan
RecruitingTohoku University Hospital
Miyagi, Japan
RecruitingOkayama University Hospital
Okayama Okayama, Japan
RecruitingOsaka Metropolitan University Hospital
Osaka, Japan
RecruitingHokkaido University Hospital
Sapporo Hokkaido, Japan
RecruitingTokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, Japan
RecruitingAmsterdam University Medical Centre
Amsterdam, Netherlands
RecruitingMaastricht University Medical Center
Maastricht, Netherlands
RecruitingHospital General Universitario Vall D Hebron
Barcelona, Spain
RecruitingHospital de La Santa Creu I Sant Pau
Barcelona, Spain
RecruitingHospital Universitario Donostia
Donostia / San Sebastian, Spain
RecruitingInstitut Catala Doncologia Ico - Hospital Duran I Reynals Location
L'Hospitalet de Llobregat, Spain
RecruitingHospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Spain
RecruitingHospital General Universitario Gregorio Maranon
Madrid, Spain
RecruitingHospital Puerta de Hierro
Majadahonda, Spain
RecruitingHospital Clinico Universitario de Salamanca
Salamanca, Spain
RecruitingHospital Universitario Virgen Del Rocio
Seville, Spain
RecruitingHospital Universitari I Politecnic La Fe
Valencia, Spain
RecruitingHospital Universitario Miguel Servet
Zaragoza, Spain
RecruitingBristol Haematology and Oncology Centre
Bristol, United Kingdom
RecruitingQueen Elizabeth University Hospital
Glasgow, United Kingdom
RecruitingSt James University Hospital
Leeds, United Kingdom
RecruitingRoyal Marsden Hospital
London, United Kingdom
RecruitingUniversity College London Hospitals (Uclh)
London, United Kingdom
RecruitingManchester University Nhs Foundation Trust
Manchester, United Kingdom
RecruitingNottingham University Hospitals
Nottingham, United Kingdom
RecruitingPlymouth Hospitals Nhs Trust
Plymouth, United Kingdom
Recruiting
Study team
Sponsor
Incyte Corporation
Study ID INCA34176-357
Study director
Albert Assad, MD
Incyte Corporation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.