Itolizumab for Acute Graft-versus-Host Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Acute Graft-versus-Host Disease+3 MoreItolizumab - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Graft-versus-Host Disease
  • Acute Graft-versus-Host Disease
  • Graft Versus Host Disease
  • Graft-Versus-Host Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 99

Day 29
Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures
The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
Day 99
Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Itolizumab (EQ001)
1 of 2
EQ001 Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Itolizumab · Has Placebo Group · Phase 3

Itolizumab (EQ001)
Biological
Experimental Group · 1 Intervention: Itolizumab · Intervention Types: Biological
EQ001 Placebo
Drug
PlaceboComparator Group · 1 Intervention: EQ001 Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 99

Who is running the clinical trial?

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

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had an initial allogeneic HSCT.
You have evidence of myeloid engraftment.
You have 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.