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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Axatilimab + Corticosteroids 		Axatilimab and Corticosteroids at the protocol-defined dose.
  • Drug: INCA034176
    IV infusion
    Other names:
    • Axatilimab
  • Drug: Corticosteroids
    Oral/IV Infusion
    Other names:
    • prednisone, methylprednisolone, prednisolone
Experimental
Placebo + Corticosteroids 		Matching placebo and Corticosteroids at the protocol-defined dose.
  • Drug: Placebo
    IV infusion
  • Drug: Corticosteroids
    Oral/IV Infusion
    Other names:
    • prednisone, methylprednisolone, prednisolone

Recruiting Locations

University of Alabama Birmingham
Birmingham, Alabama 35294

University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California 92037

University of Southern California
Los Angeles, California 90089

Colorado Blood Cancer Institute
Denver, Colorado 80218

Childrens National Hospital
Washington D.C., District of Columbia 20010

Miami Cancer Institute
Miami, Florida 33176

Orlando Health Cancer Institute Downtown Orlando
Orlando, Florida 32806

Memorial Cancer Institute
Pembroke Pines, Florida 33026

Emory University-Winship Cancer Institute
Atlanta, Georgia 30322

University of Illinois
Chicago, Illinois 60612

The University of Kansas Cancer Center
Kansas City, Kansas 66160

Massachusetts General Hospital
Boston, Massachusetts 02114

Dana Farber Cancer Institute
Boston, Massachusetts 02215

University of Michigan
Ann Arbor, Michigan 48109

Henry Ford Hospital
Detroit, Michigan 48202

Corewell Health Hematology Oncology
Grand Rapids, Michigan 49503

Hackensack University Medical Center
Hackensack, New Jersey 07601

Rutgers Cancer Institute of Nj
New Brunswick, New Jersey 08903

University of Rochester Medical Center
Rochester, New York 14642

Stony Brook University Medical Center
Stony Brook, New York 11794

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157

Oregon Health and Science University
Portland, Oregon 97239

Jefferson University Hospitals
Philadelphia, Pennsylvania 19107

Medical University of South Carolina
Charleston, South Carolina 29425

Prisma Health Upstate
Greenville, South Carolina 29615

Baptist Cancer Center
Memphis, Tennessee 38120

St David'S South Austin Medical Center
Austin, Texas 78704

Texas Transplant Institute
San Antonio, Texas 78229

Intermountain Blood and Marrow Transplant
Salt Lake City, Utah 84143

Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23298

West Virginia University Cancer Institute
Morgantown, West Virginia 26506

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.