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

Sponsor
Equillium (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05263999
Collaborator
Biocon Limited (Industry)
200
Enrollment
6
Locations
2
Arms
30.1
Anticipated Duration (Months)
33.3
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Itolizumab
  • Drug: EQ001 Placebo
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
Actual Study Start Date :
Apr 29, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/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]
Other Names:
  • EQ001
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. [Day 29]

      Complete response at Day 29

    Secondary Outcome Measures

    1. Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids. [Day 99]

      Durable Complete Response rate from Day 29 through Day 99

    2. Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures, [Day 29]

      Overall Response Rates at Day 29

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.

    2. Is age ≥12 years and >40kg at informed consent/assent.

    3. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.

    4. Has evidence of myeloid engraftment

    5. 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.

    6. 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

    Exclusion Criteria:

    1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.

    2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.

    3. Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.

    4. Evidence of cGVHD or overlap syndrome

    5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.

    6. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    3 University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    4 University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    5 Sarah Cannon Research Institute, LLC (SCRI) Nashville Tennessee United States 37203
    6 Vancouver Coastal Health Authority Vancouver British Columbia Canada V5Z 1M9

    Sponsors and Collaborators

    • Equillium
    • Biocon Limited

    Investigators

    • Study Director: Maple Fung, MD, Equillium, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Equillium
    ClinicalTrials.gov Identifier:
    NCT05263999
    Other Study ID Numbers:
    • EQ-100-02
    First Posted:
    Mar 3, 2022
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Jul 6, 2022