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A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

PHASE3RECRUITING

This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids.

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Study details:

This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
  • Is age ≥12 years and >40kg at informed consent/assent.
  • Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
  • Has evidence of myeloid engraftment
  • Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
  • Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.
  • Exclusion criteria

  • Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
  • An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
  • Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
  • Evidence of cGVHD or overlap syndrome
  • Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
  • Use of any systemic corticosteroids of >0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.
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    Eligibility

    Age eligible for study : 12 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-04-29

    Primary completion: 2024-12-01

    Study completion finish: 2025-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05263999

    Intervention or treatment

    BIOLOGICAL: Itolizumab

    DRUG: EQ001 Placebo

    Conditions

    • Graft Versus Host Disease
    • GVHD
    • Acute-graft-versus-host Disease
    • Acute GVHD
    • aGVHD

    Find a site

    Closest Location:

    Royal Adelaide Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Adelaide Hospital

      Adelaide, Not Specified, Australia

    • Westmead Hospital

      Westmead, Not Specified, Australia

    • Royal Melbourne Hospital

      East Melbourne, Not Specified, Australia

    • Austin Health

      Heidelberg, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Itolizumab (EQ001)
    • Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
    BIOLOGICAL: Itolizumab
    • Itolizumab \[Bmab600\]
    PLACEBO_COMPARATOR: EQ001 Placebo
    • EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses
    DRUG: EQ001 Placebo
    • EQ001 Placebo

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.Complete response at Day 29Day 29

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.Durable Complete Response rate from Day 29 through Day 99Day 99
    Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,Overall Response Rates at Day 29Day 29

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

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