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A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD

NCT03763318 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-18

Study results available
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Summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).

Conditions

  • Acute-graft-versus-host Disease
  • aGVHD
  • GVHD
  • GVHD, Acute

Interventions

BIOLOGICAL

EQ001

Itolizumab \[Bmab 600\])

BIOLOGICAL

EQ001 Placebo

EQ001 Placebo

Sponsors & Collaborators

  • Biocon Limited

    collaborator INDUSTRY

  • Equillium

    lead INDUSTRY

Principal Investigators

  • Joel Rothman · Equillium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2022-11-21
Completion
2022-11-21
FDA Drug
Yes

Countries

  • United States

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 NCT03763318 on ClinicalTrials.gov