A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

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

  • Chronic Graft-versus-host-disease

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 California San Diego Medical Center, Moores Cancer Center
La Jolla 5363943, California 5332921 92037

University of Southern California
Los Angeles 5368361, California 5332921 90089

Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618 80218

Childrens National Hospital
Washington D.C. 4140963, District of Columbia 4138106 20010

Orlando Health Cancer Institute Downtown Orlando
Orlando 4167147, Florida 4155751 32806

Memorial Cancer Institute
Pembroke Pines 4168139, Florida 4155751 33026

Emory University-Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322

University of Illinois
Chicago 4887398, Illinois 4896861 60612

The University of Kansas Cancer Center
Kansas City 4273837, Kansas 4273857 66160

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202

Corewell Health Hematology Oncology
Grand Rapids 4994358, Michigan 5001836 49503

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601

Rutgers Cancer Institute of Nj
New Brunswick 5101717, New Jersey 5101760 08903

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642

Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638 11794

Wake Forest Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239

Jefferson University Hospitals
Philadelphia 4560349, Pennsylvania 6254927 19107

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

Prisma Health Upstate
Greenville 4580543, South Carolina 4597040 29615

Baptist Cancer Center
Memphis 4641239, Tennessee 4662168 38120

Texas Transplant Institute
San Antonio 4726206, Texas 4736286 78229

Intermountain Blood and Marrow Transplant
Salt Lake City 5780993, Utah 5549030 84143

West Virginia University Cancer Institute
Morgantown 4815352, West Virginia 4826850 26506

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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