NCT03763318

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

A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Newly Diagnosed Acute Graft Versus Host Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Equillium · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will enroll approximately 100 subjects in two (2) parts: Part A is an open label study and will enroll approximately 40 evaluable subjects with aGVHD across 4 cohorts. The total number of patients will depend on the number of dose escalations necessary to enable a decision to be made on the recommended dose to take forward into Part B of the study. The planned dose escalation will start with cohort 1, where subjects will receive EQ001 administered intravenously every two weeks for a total of 5 doses. Part B is a randomized, double-blind, placebo-controlled study and will enroll approximately 60 additional subjects, randomized in a 2:1 ratio to either active treatment EQ001 (40) or placebo (20). Subjects will receive either EQ001 or placebo administered intravenously every two weeks for a total of 5 doses.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	EQ001	Itolizumab \[Bmab 600\])
BIOLOGICAL	EQ001 Placebo	EQ001 Placebo

Timeline

• Start date: 2019-07-15
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2018-12-04
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study