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
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 - May 2028
    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

    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.

    Protocol Summary

    Incyte Study ID:
    INCA034176-355
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    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