A Study evaluating a targeted drug (called Axatilimab) in combination with corticosteroids for people with graft-versus-host disease.A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Exclusion

• 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.