GVHD

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Incyte Study ID:
INCA34176-254
CT.gov ID:
NCT06388564
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 determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.

Clinical Study Summary

MEDICAL CONDITION(S)
  • GVHD
    • PRODUCT
  • Drug: Axatilimab
  • Drug: Ruxolitinib
  • Drug: Corticosteroids
    • COLLABORATORS
    N/A
    DATE
    Oct 2024 - Jun 2027
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    12 Years - NA
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    AZ SINT-JAN BRUGGE - OOSTENDE AV - CAMPUS SINT-JAN
    BRUGGE, Belgium, 08000
    Status
    Recruiting
    Name
    UNIVERSITAIRE ZIEKENHUIS LEUVEN - GASTHUISBERG
    LEUVEN, Belgium, 03000
    Status
    Recruiting
    Name
    AZ DELTA
    ROESELARE, Belgium, 08800
    Status
    Recruiting
    Name
    CENTRE HOSPITALIER UNIVERSITAIRE (CHU) DE LIEGE
    LIEGE, Belgium, 04000
    Status
    Recruiting
    Name
    JESSA ZIEKENHUIS
    HASSELT, Belgium, 03500
    Status
    Recruiting
    Name
    PRINCESS MARGARET CANCER CENTRE - UNIVERSITY HEALTH NETWORK
    TORONTO, ON, Canada, M5G 2M9
    Status
    Recruiting

    Key Inclusion and Exclusion 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.

    Exclusion Criteria

    • Received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
    • Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.

    Protocol Summary

    Incyte Study ID:
    INCA34176-254
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    120
    Primary Outcome
    Open

    Objective Response Rate

    Timeframe: 6 months

    Secondary Outcome
    Open

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

    Timeframe: Up to 2 years and 30 days

    Duration of Response

    Timeframe: Up to 2 years

    Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score

    Timeframe: Up to 2 years

    Best overall response in the first 6 months

    Timeframe: Up to 6 months

    OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD.

    Timeframe: 12 months

    Proportion of participants who remain corticosteroid-free

    Timeframe: 4 weeks, 8 weeks and 6 months

    Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.

    Timeframe: Up to 2 years

    Failure-free Survival (FFS)

    Timeframe: Up to 2 years and 30 days

    Axatilimab pharmacokinetic (PK) in Plasma

    Timeframe: Up to 2 years and 30 days

    Ruxolitinib PK in Plasma

    Timeframe: Up to 2 years and 30 days