A Phase 2, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

Incyte Corporation

Summary

This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.

Eligibility

Age range: 2–17 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Aged 2 to \< 18 years at the time of randomization. * Active, moderate to severe cGVHD, requiring systemic immune suppression. * Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib. * Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed. * Participants must accept to be treated with one of the following…

Interventions

Drug
INCA034176
Axatilimab at the protocol-defined dose.
Drug
Best available Treatment (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Locations (41)

City of Hope Medical Center
Duarte, California
Children'S Hospital Los Angeles Specialt
Los Angeles, California
Lucile Packard Child Hospital End
Palo Alto, California
Childrens National Medical Center
Washington D.C., District of Columbia
Adventhealth Pediatric Cellular Therapy and Blood and Marrow Transplant
Orlando, Florida
Childrens Healthcare of Atlanta
Atlanta, Georgia