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New combo therapy aims to tame chronic GVHD

NCT ID NCT06585774

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 16, 2026 · Updated 9 times

Summary

This study tests whether adding axatilimab to standard steroid treatment helps people with moderate to severe chronic graft-versus-host disease (cGVHD), a complication after stem cell transplant. About 240 participants aged 12 and older will receive either axatilimab or a placebo, plus steroids. The main goal is to see if the combination delays disease worsening or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
axatilimab (a drug given by IV) plus corticosteroids (steroids)
What this could lead to
If it works, this could become a new standard first treatment for chronic GVHD, helping patients live longer without the disease getting worse.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. The drug may not improve outcomes over steroids alone, and side effects like infections or infusion reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic graft versus host disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    128 sites in 13 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin I

    RECRUITING

    Vienna, 01090, Austria

  • Alberta'S Children Hospital

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Amsterdam University Medical Centre

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Anjo Kosei Hospital

    RECRUITING

    Aichi-ken, 446-8602, Japan

  • Aou Policlinico Consorziale Di Bari

    RECRUITING

    Bari, 70124, Italy

  • Asst Degli Spedali Civili Di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Austin Health Medical Oncology and Clinical Haematology

    RECRUITING

    Heidelberg, Victoria, 03084, Australia

  • Azienda Ospedaliera Card. G. Panico

    RECRUITING

    Tricase, 73039, Italy

  • Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    RECRUITING

    Palermo, 90146, Italy

  • Azienda Ospedaliero Universitaria Delle Marche

    RECRUITING

    Ancona, 60126, Italy

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

    RECRUITING

    Catania, 95123, Italy

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

    RECRUITING

    Alessandria, 15121, Italy

  • Azienda Policlinico Umberto 1 Universita Sapienza Di Roma

    RECRUITING

    Rome, 00161, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Baptist Cancer Center

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Bc Children'S Hospital

    RECRUITING

    Vancouver, British Columbia, V6G1R8, Canada

  • Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS2 8ED, United Kingdom

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

    RECRUITING

    Nantes, 44903, France

  • Centro Ricerche Cliniche Di Verona

    RECRUITING

    Verona, 37134, Italy

  • Charite Universitatsmedizin Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Childrens National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Chu Amiens Picardie - Hopital Sud

    RECRUITING

    Amiens, 80054, France

  • Chu de Nice - Hospital L Archet

    RECRUITING

    Nice, 06202, France

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Corewell Health Hematology Oncology

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Emory University-Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fujita Health University Hospital

    RECRUITING

    Aichi, 470-1192, Japan

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    RECRUITING

    Reggio Calabria, 89133, Italy

  • Gunma Saiseikai Maebashi Hospital

    RECRUITING

    Maebashi, 371-0821, Japan

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo Hokkaido, 060-0814, Japan

  • Hopitaux de Brabois

    RECRUITING

    Nancy, 54511, France

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, 69310, France

  • Hospital Clinico Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital General Universitario Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Maisonneuve Rosemont

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Hospital Puerta de Hierro

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • Hospital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hospital Universitari I Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Donostia

    RECRUITING

    Donostia / San Sebastian, 20014, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrin

    RECRUITING

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital de La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

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

    RECRUITING

    San Giovanni Rotondo, 71013, Italy

  • Innsbruck University Hospital

    RECRUITING

    Innsbruck, A-6020, Austria

  • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

    RECRUITING

    L'Hospitalet de Llobregat, 08906, Spain

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13273, France

  • Intermountain Blood and Marrow Transplant

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • Irccs Azienda Ospedaliera Universitaria San Martino

    RECRUITING

    Genova, 16132, Italy

  • Irccs Fondazione Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Jefferson University Hospitals

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • John Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Klinikum Der Philipps-Universitaet Marburg

    RECRUITING

    Marburg, 35043, Germany

  • Kobe City Medical Center General Hospital

    RECRUITING

    Hyōgo, 650-0047, Japan

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Japan

  • Landeskrankenhaus Universitatsklinikum Graz

    RECRUITING

    Graz, A-8036, Austria

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Manchester University Nhs Foundation Trust

    RECRUITING

    Manchester, M13 9WL., United Kingdom

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Cancer Institute

    RECRUITING

    Pembroke Pines, Florida, 33026, United States

  • Miami Cancer Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • National Hospital Organization Kumamoto Medical Center

    RECRUITING

    Kumamoto Kumamoto, 860-0008, Japan

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Nottingham University Hospitals

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Okayama University Hospital

    RECRUITING

    Okayama Okayama, 700-0914, Japan

  • Ordensklinikum Linz Gmbh Elisabethinen

    RECRUITING

    LINZ CET, A-4020, Austria

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Orlando Health Cancer Institute Downtown Orlando

    RECRUITING

    Orlando, Florida, 32806, United States

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, 545-8586, Japan

  • Ospedale Pediatrico Bambino Gesu Irccs

    RECRUITING

    Rome, 00165, Italy

  • Ospedale San Raffaele - Milano

    RECRUITING

    Milan, 20132, Italy

  • Plymouth Hospitals Nhs Trust

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Prisma Health Upstate

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Queen Elizabeth Ii Health Sciences Centre

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Rigshospitalet

    RECRUITING

    Copenhagen, 02100, Denmark

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 05000, Australia

  • Royal Marsden Hospital

    RECRUITING

    London, SM2 5PT, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Sydney, New South Wales, 02050, Australia

  • Rutgers Cancer Institute of Nj

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • St David'S South Austin Medical Center

    RECRUITING

    Austin, Texas, 78704, United States

  • St. Anna Childrens Hospital

    RECRUITING

    Vienna, 01090, Austria

  • St. James Hospital

    RECRUITING

    Dublin, Ireland

  • Stollery Children'S Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Stony Brook University Medical Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Texas Transplant Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Tohoku University Hospital

    RECRUITING

    Miyagi, 980-8574, Japan

  • Tokai University Hospital

    RECRUITING

    Isehara Kanagawa, 259-1193, Japan

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    RECRUITING

    Tokyo, 113-0021, Japan

  • UCSF

    RECRUITING

    San Francisco, California, 94143, United States

  • Universitaetsklinikum Bonn, University Hospital Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitaetsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Universitatsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitatsklinikum Halle (Saale)

    RECRUITING

    Halle, 06120, Germany

  • Universitatsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitatsklinikum Munster

    RECRUITING

    Münster, 48149, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    RECRUITING

    Mainz, 55131, Germany

  • University Clinic Carl Gustav Carus Technical University Dresden

    RECRUITING

    Dresden, 01307, Germany

  • University College London Hospitals (Uclh)

    RECRUITING

    London, WC1E 6AG, United Kingdom

  • University Hospital Duesseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • University Hospital Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, 24105, Germany

  • University Hospital of Ulm, Universitatsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University Medical Center Rwth Aachen

    RECRUITING

    Aachen, D-52074, Germany

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arizona Cancer Center-Out Pt.

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of California San Diego Medical Center, Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90089, United States

  • Upmc Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Vancouver General Hospital

    RECRUITING

    Vancouver, V5Z1M9, Canada

  • Virginia Commonwealth University Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • West Virginia University Cancer Institute

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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