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New drug duo aims to tame Graft-Versus-Host disease

NCT ID NCT06388564

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether adding axatilimab to the standard drug ruxolitinib works better for people newly diagnosed with moderate to severe chronic graft-versus-host disease (cGVHD), a complication after stem cell transplant. About 130 participants aged 12 and older will receive the combination or standard care. The main goal is to see if the combination leads to a complete or partial response within 6 months without needing new therapy.

What this could mean

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

Active substance
axatilimab and ruxolitinib
What this could lead to
If successful, this combination could offer a more effective first-line treatment for chronic graft-versus-host disease, potentially reducing the need for long-term steroids.
What could go wrong
This is an early Phase 2 trial with only 130 participants, so results may not apply to everyone. Side effects from the drug combination are possible, and the study is not yet complete.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

130 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Dec 2029

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 1 allo-SCT (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells). * Adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: ANC ≥ 0.75 × 109/L and platelet count ≥ 20 × 109/L. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Received more than 1 prior allo-SCT. Prior autologous HCT is allowed. * Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD. * Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis. * Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication. * Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1. * Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity. * Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse. * History of acute or chronic pancreatitis. * History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry. * Active symptomatic myositis. * 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 end-stage renal disease on dialysis. Participants with CrCl of 30 to 59 mL/min on treatment with fluconazole are not eligible. * 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. * Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to randomization. * 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

Contacts and locations

Locations

  • A.O.U. Citta Della Salute E Della Scienza Di Torino

    Torino, 10126, Italy

  • AZ DELTA

    Roeselare, 08800, Belgium

  • Aou Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T3N 4N1, Canada

  • Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan

    Bruges, 08000, Belgium

  • Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

    Bergamo, 24127, Italy

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Centre Hospitalier Universitaire (Chu) de Liege

    Liège, 04000, Belgium

  • Chu Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Clatterbridge Cancer Center

    Liverpool, L7 8YA, United Kingdom

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico Di Milano Uo Dermatologia

    Milan, 20122, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Fred and Pamela Buffett Cancer Center

    Omaha, Nebraska, 68198, United States

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Hospital Clinic Barcelona Main

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29011, Spain

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, 30120, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Ico Institut Catala D Oncologia

    Granvia de L'hospitalet 199-203, 08908, Spain

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Jessa Ziekenhuis

    Hasselt, 03500, Belgium

  • Klinikum Der Johann Wolfgang Goethe University

    Frankfurt am Main, 60590, Germany

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ospedale Pediatrico Bambino Gesu Irccs

    Rome, 00165, Italy

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Rome, 00168, Italy

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Smilow Cancer Center-Yale

    New Haven, Connecticut, 06510, United States

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • Universitaetsklinikum Jena

    Jena, 07747, Germany

  • Universitaetsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000, Belgium

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650, Belgium

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • Universitatklinikum Freiburg

    Freiburg I. Breisgau, 79106, Germany

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251, Germany

  • University Hospital Mannheim

    Mannheim, 68167, Germany

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic

    Los Angeles, California, 90095, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • University of Maryland-Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vancouver General Hospital

    Vancouver, V5Z1M9, Canada

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.