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Clinical Trials in the UK / NCT06585774
Recruiting Phase 3

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

NCT06585774 · tracked via the Priya Life Science UK tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2025-01-21
Last updated
2026-08-06

Condition(s) studied

Chronic Graft-versus-host-disease

Investigational drug(s) / intervention(s)

INCA034176PlaceboCorticosteroids

INCA034176: IV infusion

Placebo: IV infusion

Corticosteroids: Oral/IV Infusion

Study 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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
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.

Primary outcome measure(s)

Trial sites (126)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama Recruiting
University of Arizona Cancer Center-Out Pt. Tucson Arizona Recruiting
City of Hope Medical Center Duarte California Recruiting
University of California San Diego Medical Center, Moores Cancer Center La Jolla California Recruiting
University of Southern California Los Angeles California Recruiting
UCSF San Francisco California Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Childrens National Hospital Washington D.C. District of Columbia Recruiting
Miami Cancer Institute Miami Florida Recruiting
Orlando Health Cancer Institute Downtown Orlando Orlando Florida Recruiting
Memorial Cancer Institute Pembroke Pines Florida Recruiting
Emory University-Winship Cancer Institute Atlanta Georgia Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
University of Illinois Chicago Illinois Recruiting
The University of Kansas Cancer Center Kansas City Kansas Recruiting
John Hopkins Hospital Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Corewell Health Hematology Oncology Grand Rapids Michigan Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Rutgers Cancer Institute of Nj New Brunswick New Jersey Recruiting
University of Rochester Medical Center Rochester New York Recruiting
Stony Brook University Medical Center Stony Brook New York Recruiting
Wake Forest Baptist Medical Center Winston-Salem North Carolina Recruiting
Oregon Health and Science University Portland Oregon Recruiting
Jefferson University Hospitals Philadelphia Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Prisma Health Upstate Greenville South Carolina Recruiting
Baptist Cancer Center Memphis Tennessee Recruiting
St David'S South Austin Medical Center Austin Texas Recruiting
Texas Transplant Institute San Antonio Texas Recruiting
Intermountain Blood and Marrow Transplant Salt Lake City Utah Recruiting
Virginia Commonwealth University Massey Cancer Center Richmond Virginia Recruiting
West Virginia University Cancer Institute Morgantown West Virginia Recruiting
Royal Prince Alfred Hospital Sydney New South Wales Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Austin Health Medical Oncology and Clinical Haematology Heidelberg Victoria Recruiting
Landeskrankenhaus Universitatsklinikum Graz Graz Austria Recruiting

+ 86 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06585774 on ClinicalTrials.gov ↗ ← All trials in the UK