NCT06585774 A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
| NCT ID | NCT06585774 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Incyte Corporation |
| Condition | Chronic Graft-versus-host-disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2027-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2025-01-21 with a primary completion date of 2027-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Eligibility Criteria
Inclusion Criteria: * ≥ 12 years of age at the time of informed consent. * New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy. * History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible. * Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * 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. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Contact & Investigator
Albert Assad, MD
STUDY DIRECTOR
Incyte Corporation
Frequently Asked Questions
Who can join the NCT06585774 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Chronic Graft-versus-host-disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06585774 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT06585774 currently recruiting?
Yes, NCT06585774 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT06585774 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, Los Angeles, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT06585774 clinical trial?
NCT06585774 is sponsored by Incyte Corporation. The principal investigator is Albert Assad, MD at Incyte Corporation. The trial plans to enroll 240 participants.