Phase 3 Study Comparing Axatilimab Plus Corticosteroids Versus Placebo for Initial Treatment of Moderate to Severe Chronic Graft-Versus-Host Disease

What this Trial Is About

Researchers are evaluating the effectiveness of axatilimab combined with corticosteroids compared to a placebo with corticosteroids as the initial treatment for moderate or severe chronic graft-versus-host disease cGVHD. This Phase 3 randomized, double-blind, placebo-controlled study aims to improve treatment outcomes for patients experiencing cGVHD after allogeneic hematopoietic cell transplantation allo-HCT. Participants will receive either axatilimab or a matching placebo, both administered by intravenous infusion, alongside corticosteroids given orally or by infusion at protocol-defined doses. The study randomly assigns participants to one of these two treatment groups to compare their effects as initial therapy for cGVHD. During the study, participants will be monitored over a period of up to three years to assess event-free survival and other outcomes such as response rates, corticosteroid dose reduction, survival, and safety. Researchers will collect data including laboratory tests, monocyte phenotype changes, and bone health markers. This comprehensive monitoring is designed to evaluate the benefits and risks of the treatments throughout and following the active treatment period.

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