Share
Save
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
PHASE3
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
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/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Itolizumab (EQ001)
| BIOLOGICAL: Itolizumab
|
PLACEBO_COMPARATOR: EQ001 Placebo
| DRUG: EQ001 Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary 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 29 | Day 29 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary 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 99 | Day 99 |
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures, | Overall Response Rates at Day 29 | Day 29 |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!