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

Phase 3

Terminated

• Conditions: GVHD; Graft Versus Host Disease; Acute-graft-versus-host Disease; Acute GVHD; aGVHD
• Interventions: Biological: Itolizumab; Drug: EQ001 Placebo

• Registration Number: NCT05263999
• Lead Sponsor: Equillium

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

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 Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Study Start: 2022-04-29
• Primary Completion: 2025-04-22
• Study Completion: 2025-05-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Itolizumab (EQ001)	Itolizumab	Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
EQ001 Placebo	EQ001 Placebo	EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,	Day 29	Overall Response Rates at Day 29
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

Trial Locations

Locations (118)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

City of Hope; 🇺🇸 Duarte, California, United States

University of California, San Diego (UCSD) - Moores Cancer Center; 🇺🇸 La Jolla, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of California, Los Angeles (UCLA) - Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

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