Axatilimab for Graft-versus-Host Disease
Recruiting at 37 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (US)
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Incyte Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
IM
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for kids aged 2-18 with chronic Graft-Versus-Host Disease who've tried at least two systemic therapies. They must be on a stable dose of corticosteroids or other approved treatments and have had an allo-HCT from any donor.Inclusion Criteria
I am between 2 and 17 years old.
I have chronic GVHD needing treatment.
I have cGVHD and have tried at least 2 treatments, including steroids and ruxolitinib.
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What Are the Treatments Tested in This Trial?
Interventions
- Axatilimab
Trial Overview The study compares Axatilimab to the Best Available Therapy in children with chronic GVHD after failing previous treatments. It aims to see if Axatilimab is more effective in managing their condition.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Best available Treatment (BAT)Experimental Treatment1 Intervention
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.
Group II: AxatilimabExperimental Treatment1 Intervention
Axatilimab at the protocol-defined dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Trials
408
Recruited
66,800+
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
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