Status:
TERMINATED
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
Lead Sponsor:
Equillium
Collaborating Sponsors:
Biocon Limited
Conditions:
Graft Versus Host Disease
GVHD
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05263999
Start Date
April 29 2022
End Date
May 12 2025
Last Update
June 17 2025
Active Locations (118)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
City of Hope
Duarte, California, United States, 91010
3
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States, 92093
4
University of Southern California
Los Angeles, California, United States, 90033