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Corticosteroid

Itolizumab + Corticosteroids for Acute Graft-Versus-Host Disease

Phase 3
Recruiting
Research Sponsored by Equillium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
Is age ≥12 years and >40kg at informed consent/assent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 99
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is better than placebo at treating aGVHD, a serious complication from stem cell transplants.

Who is the study for?
This trial is for individuals over 12 years old and heavier than 40kg who have had a bone marrow transplant and are now facing a severe reaction called acute Graft Versus Host Disease (aGVHD). They should have started steroid treatment within the past 72 hours. People with chronic GVHD, other ongoing treatments for aGVHD besides steroids, or those with certain types of cancer relapse or persistent disease aren't eligible.Check my eligibility
What is being tested?
The study is testing Itolizumab in combination with corticosteroids against a placebo plus corticosteroids to see which is better as an initial treatment for severe forms of aGVHD following bone marrow transplantation.See study design
What are the potential side effects?
Itolizumab may cause immune system reactions, infections due to lowered immunity, infusion-related reactions similar to allergic responses, and potential impact on liver function. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a stem cell transplant from a donor.
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I am 12 years or older and weigh more than 40kg.
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I started corticosteroid treatment for aGVHD less than 3 days ago and will get a specific dose on Day 1.
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I have a severe form of acute graft-versus-host disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 99
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 99 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
Secondary outcome measures
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures
Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Itolizumab (EQ001)Experimental Treatment1 Intervention
Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
Group II: EQ001 PlaceboPlacebo Group1 Intervention
EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses

Find a Location

Who is running the clinical trial?

Biocon LimitedIndustry Sponsor
13 Previous Clinical Trials
692 Total Patients Enrolled
EquilliumLead Sponsor
6 Previous Clinical Trials
133 Total Patients Enrolled
Maple Fung, MDStudy DirectorEquillium, Inc.
1 Previous Clinical Trials

Media Library

Corticosteroids (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05263999 — Phase 3
Graft-versus-Host Disease Research Study Groups: Itolizumab (EQ001), EQ001 Placebo
Graft-versus-Host Disease Clinical Trial 2023: Corticosteroids Highlights & Side Effects. Trial Name: NCT05263999 — Phase 3
Corticosteroids (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05263999 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for participants in this trial?

"The study is still ongoing, as seen from the clinicaltrials.gov website. This experiment was first advertised on April 29th, 2022 and has had a recent update on October 28th, 2022."

Answered by AI

In how many hospitals is this study being conducted?

"This trial is currently being conducted at 15 research institutions, including McGill University Health Center - Research Institute in Montréal, University of Alabama at Birmingham in Birmingham, Fred Hutchinson Cancer Research Center in Seattle, and 12 other locations."

Answered by AI

How many people are participating in this research project?

"In order to move forward, this study requires the recruitment of 200 patients that meet specific inclusion criteria. The trial is being conducted at multiple locations, such as McGill University Health Center - Research Institute in Montréal, Quebec and University of Alabama at Birmingham in Birmingham, Alabama."

Answered by AI

Are there any recorded allergic reactions to Itolizumab?

"There is evidence from prior clinical trials to support the safety of Itolizumab, so it received a score of 3."

Answered by AI
~15 spots leftby Jul 2024