NCT04007198

A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma

A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Moderate-to-Severe Uncontrolled Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Equillium · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with moderate-to-severe asthma.

Detailed description

The study will enroll up to 40 subjects, with up to 5 dose escalating cohorts of 8 patients enrolled in a 3:1 ratio. Subjects will receive either itolizumab or placebo administered subcutaneously every two weeks (over 8 weeks) for a total of 5 doses with 4 weeks of follow-up.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	EQ001	Itolizumab \[Bmab 600\]
DRUG	EQ001 Placebo	EQ001 Placebo

Timeline

• Start date: 2019-06-20
• Primary completion: 2021-10-12
• Completion: 2021-10-12
• First posted: 2019-07-05
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

13 sites across 2 countries: Australia, New Zealand