GVHD

A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

Incyte Study ID:
INCA034176-355
CT.gov ID:
NCT06821542
Eudra ID:
N/A
EU CT Number:
2024-518973-32-00
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

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

Clinical Study Summary

MEDICAL CONDITION(S)
  • GVHD
    • PRODUCT
  • Drug: INCA034176
  • Drug: Best Available Therapy (BAT)
    • COLLABORATORS
    N/A
    DATE
    Jun 2025 - Nov 2032
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    KRANKENHAUS DER ELISABETHINEN LINZ GMBH
    LINZ, Austria, 04020
    Status
    Not yet recruiting
    Name
    ST. ANNA CHILDRENS HOSPITAL
    VIENNA, Austria, 01090
    Status
    Not yet recruiting
    Name
    MEDIZINISCHE UNIVERSITAT WIEN, UNIVERSITATSKLINIK FUR INNERE MEDIZIN I
    WIEN, Austria, 01090
    Status
    Not yet recruiting
    Name
    MEDIZINISCHE UNIVERSITAET INNSBRUCK - UNIVERSITAETSKLINIK FUER INNERE MEDIZIN III
    INNSBRUCK, Austria, 06020
    Status
    Not yet recruiting
    Name
    MEDICAL UNIVERSITY OF GRAZ
    GRAZ, Austria, 08036
    Status
    Not yet recruiting
    Name
    CHU LIEGE -CENTRE HOSPITALIER UNIVERSITAIRE SART TILMAN
    LIEGE, Belgium, 04000
    Status
    Not yet recruiting
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Age ≥ 12 years at the time of signing the ICF.
    • Active, moderate to severe cGVHD, requiring systemic immune suppression.

    Exclusion Criteria

    • Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.
    • Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI 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.
    Requirements information
    Inclusion Criteria
    • Age ≥ 12 years at the time of signing the ICF.
    • 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 BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, pentostatin, proteasome inhibitors, imatinib, or ibrutinib.
    • 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.
    Exclusion Criteria
    • Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.
    • Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI 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.
    • Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
    • Severe renal impairment, that is, estimated creatinine clearance < 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage 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.
    • History of acute or chronic pancreatitis.
    • Active, symptomatic myositis.
    • Pregnant or breastfeeding.
    • Other protocol-defined Inclusion/Exclusion Criteria may apply.

    Protocol Summary

    Incyte Study ID:
    INCA034176-355
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCA034176
  • Drug: Best Available Therapy (BAT)
    • Enrollment:
    300
    Primary Outcome
    Open

    Objective Response (OR) at 6 months

    Timeframe: 6 months

    Secondary Outcome
    Open

    Failure-free survival (FFS)

    Timeframe: Up to 5 years

    Proportion of participants with a ≥ 7-point improvement in modified Lee Symptom Scale (mLSS) total score

    Timeframe: Up to 5 years

    Overall Response at 12 months

    Timeframe: 12 months

    Best Overall Response (BOR)

    Timeframe: Up to 5 years

    DOR (in responders only)

    Timeframe: Up to 5 years

    Organ-specific response

    Timeframe: Up to 5 years

    Overall Survival (OS)

    Timeframe: Up to 5 years

    Nonrelapse mortality (NRM)

    Timeframe: Up to 5 years

    Time to primary hematologic disease relapse

    Timeframe: Up to 5 years

    Percent reduction in daily corticosteroid dose at 6 months

    Timeframe: 6 months

    Proportion of participants who tapered off all corticosteroids at 6 months

    Timeframe: 6 months

    Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 5 years and 30 days