Recruiting
Phase 3

Axatilimab & Corticosteroids

Sponsor:

Incyte Corporation

Code:

NCT06585774

Conditions

Chronic Graft-versus-host-disease

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

INCA034176

Placebo

Corticosteroids

Study Details

Brief 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).

Conditions

Chronic Graft-versus-host-disease

Study ID

NCT06585774

Start date

Jan 21, 2025

Status verified date

Sep, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Sep 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Axatilimab + Corticosteroids

Axatilimab and Corticosteroids at the protocol-defined dose.

experimental: Placebo + Corticosteroids

Matching placebo and Corticosteroids at the protocol-defined dose.

Interventions

INCA034176

IV infusion

Placebo

IV infusion

Corticosteroids

Oral/IV Infusion

Primary outcome measure

  • Event Free Survival (EFS) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

University of Arizona Cancer Center-Out Pt.

Recruiting

Tucson, Arizona, United States, 85719

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

University of California San Diego Medical Center, Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

UCSF

Recruiting

San Francisco, California, United States, 94143

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Childrens National Hospital

Recruiting

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

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Orlando Health Cancer Institute Downtown Orlando

Recruiting

Orlando, Florida, United States, 32806

Memorial Cancer Institute

Recruiting

Pembroke Pines, Florida, United States, 33026

Emory University-Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

The University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

John Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Corewell Health Hematology Oncology

Recruiting

Grand Rapids, Michigan, United States, 49503

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of Nj

Recruiting

New Brunswick, New Jersey, United States, 08903

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Jefferson University Hospitals

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Upmc Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Prisma Health Upstate

Recruiting

Greenville, South Carolina, United States, 29615

Baptist Cancer Center

Recruiting

Memphis, Tennessee, United States, 38120

St David'S South Austin Medical Center

Recruiting

Austin, Texas, United States, 78704

Texas Transplant Institute

Recruiting

San Antonio, Texas, United States, 78229

Intermountain Blood and Marrow Transplant

Recruiting

Salt Lake City, Utah, United States, 84143

Virginia Commonwealth University Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

West Virginia University Cancer Institute

Recruiting

Morgantown, West Virginia, United States, 26506

Alberta'S Children Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Stollery Children'S Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Bc Children'S Hospital

Recruiting

Vancouver, British Columbia, Canada, V6G1R8

Queen Elizabeth Ii Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Hospital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Vancouver General Hospital

Recruiting

Vancouver, Canada, V5Z1M9

More Information

Sponsor

Incyte Corporation

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • cGVHD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.