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Monoclonal Antibodies

Axatilimab + Corticosteroids for Chronic Graft-Versus-Host Disease

Phase 3
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Pivotal Trial

Summary

This trial will compare how well a new drug, axatilimab, works with corticosteroids compared to a placebo with corticosteroids in treating moderate or severe chronic graft-versus

Who is the study for?
This trial is for individuals aged 12 or older who have recently been diagnosed with moderate to severe chronic graft-versus-host disease (cGVHD) after a stem cell transplant from any donor. They must need systemic therapy, have stable blood counts without growth factors, and be willing to prevent pregnancy.
What is being tested?
The study compares the effectiveness of axatilimab plus corticosteroids against a placebo combined with corticosteroids in treating cGVHD as an initial treatment. Participants will randomly receive either the drug or placebo.
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression by corticosteroids, changes in blood pressure, mood swings, weight gain, and elevated blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a new case of severe chronic GVHD needing systemic treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event Free Survival (EFS)
Secondary study objectives
Best Overall Response (BOR)
DOR (in responders only)
Event Free Survival 2
+8 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo + CorticosteroidsExperimental Treatment2 Interventions
Matching placebo and Corticosteroids at the protocol-defined dose.
Group II: Axatilimab + CorticosteroidsExperimental Treatment2 Interventions
Axatilimab and Corticosteroids at the protocol-defined dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
393 Previous Clinical Trials
63,726 Total Patients Enrolled
Albert Assad, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
417 Total Patients Enrolled
~160 spots leftby Sep 2027
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