GVHD

A study to evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Incyte Study ID:
INCA34176-357
CT.gov ID:
NCT06585774
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 the efficacy of axatilimab versus

placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Clinical Study Summary

MEDICAL CONDITION(S)
  • GVHD
    • PRODUCT
  • Drug: INCA034176
  • Drug: Placebo
  • Drug: Corticosteroids
    • COLLABORATORS
    N/A
    DATE
    Jan 2025 - Sep 2027
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12 Years - NA
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    PRISMA HEALTH UPSTATE
    GREENVILLE, SC, US, 29615
    Status
    Recruiting
    Name
    NATIONAL HOSPITAL ORGANIZATION KUMAMOTO MEDICAL CENTER
    KUMAMOTO KUMAMOTO, Japan, 860-0008
    Status
    Recruiting
    Name
    OSAKA METROPOLITAN UNIVERSITY HOSPITAL
    OSAKA, Japan, 545-8586
    Status
    Recruiting
    Name
    GUNMA SAISEIKAI MAEBASHI HOSPITAL
    MAEBASHI, Japan, 371-0821
    Status
    Recruiting
    Name
    KOBE CITY MEDICAL CENTER GENERAL HOSPITAL
    HYOGO, Japan, 650-0047
    Status
    Recruiting
    Name
    HIROSHIMA UNIVERSITY HOSPITAL
    HIROSHIMA-SHI, Japan, 734-8551
    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-HCT. 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:
    INCA34176-357
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    240
    Primary Outcome
    Open

    Event Free Survival (EFS)

    Timeframe: Up to 3 years

    Secondary Outcome
    Open

    Objective Response (OR)

    Timeframe: 6 months

    Event Free Survival 2

    Timeframe: Up to 3 years

    Proportion of participants with a ≥ 7-point improvement in mLSS total score

    Timeframe: Up to 3 years

    Overall Response

    Timeframe: 12 Months

    DOR (in responders only)

    Timeframe: Up to 3 years

    Best Overall Response (BOR)

    Timeframe: Up to 3 years

    Overall Survival (OS)

    Timeframe: Up to 3 years

    Nonrelapse mortality (NRM)

    Timeframe: Up to 3 years

    Failure-free survival (FFS)

    Timeframe: Up to 3 years

    Relapse of hematologic diseases

    Timeframe: Up to 3 years

    Time to primary hematologic disease relapse

    Timeframe: Up to 3 years

    Percent reduction in daily corticosteroid dose

    Timeframe: 6 months

    Proportion of participants who tapered off all corticosteroids

    Timeframe: 6 months

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

    Timeframe: Up to 3 years and 30 days

    Change from baseline in circulating monocyte number and phenotype (CD14/16)

    Timeframe: Up to 3 years and 30 days

    Change from baseline in soluble markers for bone resorption and formation, including bone-specific alkaline phosphatase (BAP) and C-terminal telopeptide (CTX)

    Timeframe: Up to 3 years and 30 days