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

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ClinicalTrials.gov Identifier: NCT05263999
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : April 5, 2024
Sponsor:
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium

Study Description
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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
Graft Versus Host Disease GVHD Acute-graft-versus-host Disease Acute GVHD aGVHD 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 29, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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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
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Primary Outcome Measures :
  1. The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. [ Time Frame: 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. [ Time Frame: 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, [ Time Frame: Day 29 ]
    Overall Response Rates at Day 29


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 1.

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05263999


Contacts
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Contact: Clinical Trial Manager 858-240-1200 clinicaltrials@equilliumbio.com

Locations
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Sponsors and Collaborators
Equillium
Biocon Limited
Investigators
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Study Director: Maple Fung, MD Equillium, Inc.
More Information
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Additional Information:

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Responsible Party: Equillium
ClinicalTrials.gov Identifier: NCT05263999    
Other Study ID Numbers: EQ-100-02
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases