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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab (INCA034176) and Corticosteroids as Initial Treatment for Chronic Graft-Versus Host Disease (AXemplify 357)
EU CTIS ID: 2023-510292-65-00
What this study is testing
To compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 12 years of age at the time of informed consent.
- Ability to comprehend and willingness to sign a written ICF for the study. A parent/guardian should provide consent for pediatric participants unable to provide consent themselves; in addition, where applicable, pediatric participants should sign their own assent form.
- New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy (Jagasia et al 2015). a. Moderate cGVHD: At least 1 organ (except lung) with a score of 2, ≥ 3 organs involved with a score of 1 in each organ, or lung score of 1. b. Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3. Note 1: Diagnosis of cGVHD requires at least 1 diagnostic feature of cGVHD or at least 1 distinctive feature plus additional test such as biopsy, PFTs, Schirmer test, or radiographic imaging showing cGVHD in the same or another organ (see Appendix C). Participants with single-organ, genitourinary involvement or liver involvement as the only manifestation of cGVHD are not eligible. Note 2: Candidates who transition from active aGVHD to cGVHD without tapering off corticosteroids (< 0.25 mg/kg per day methylprednisolone or equivalent) and/or CNIs are eligible.
- 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.
- KPS score ≥ 60% if 16 years of age or older; LPS score ≥ 60% if younger than 16 years of age.
- Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
You likely can't join if
- Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
- Suspected active or latent tuberculosis (as confirmed by a positive QuantiFERON® test).
- 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. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
- Maintenance therapy for the primary hematologic disease started within 4 weeks before initiation of study treatment (Day 1) or plans to start maintenance therapy after Day 1.
- Corticosteroid therapy at doses > 0.25 mg/kg per day methylprednisolone or equivalent for any treatment other than the diagnosis of cGVHD within 7 days of randomization.
See the full eligibility criteria
Who can join
- ≥ 12 years of age at the time of informed consent.
- Ability to comprehend and willingness to sign a written ICF for the study. A parent/guardian should provide consent for pediatric participants unable to provide consent themselves; in addition, where applicable, pediatric participants should sign their own assent form.
- New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy (Jagasia et al 2015). a. Moderate cGVHD: At least 1 organ (except lung) with a score of 2, ≥ 3 organs involved with a score of 1 in each organ, or lung score of 1. b. Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3. Note 1: Diagnosis of cGVHD requires at least 1 diagnostic feature of cGVHD or at least 1 distinctive feature plus additional test such as biopsy, PFTs, Schirmer test, or radiographic imaging showing cGVHD in the same or another organ (see Appendix C). Participants with single-organ, genitourinary involvement or liver involvement as the only manifestation of cGVHD are not eligible. Note 2: Candidates who transition from active aGVHD to cGVHD without tapering off corticosteroids (< 0.25 mg/kg per day methylprednisolone or equivalent) and/or CNIs are eligible.
- 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.
- KPS score ≥ 60% if 16 years of age or older; LPS score ≥ 60% if younger than 16 years of age.
- 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.
What rules you out
- Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
- Suspected active or latent tuberculosis (as confirmed by a positive QuantiFERON® test).
- 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. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
- Maintenance therapy for the primary hematologic disease started within 4 weeks before initiation of study treatment (Day 1) or plans to start maintenance therapy after Day 1.
- Corticosteroid therapy at doses > 0.25 mg/kg per day methylprednisolone or equivalent for any treatment other than the diagnosis of cGVHD within 7 days of randomization.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Australia
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Australia; United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.