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

NCT05263999 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-06-17

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

Itolizumab

Itolizumab \[Bmab600\]

DRUG

EQ001 Placebo

EQ001 Placebo

Sponsors & Collaborators

  • Biocon Limited

    collaborator INDUSTRY

  • Equillium

    lead INDUSTRY

Principal Investigators

  • Chief Development Officer · Equillium, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2025-04-22
Completion
2025-05-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • New Zealand
  • Portugal
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05263999 on ClinicalTrials.gov