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

NCT04007198 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

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 itolizumab (EQ001) in subjects with moderate-to-severe asthma.

Conditions

Interventions

DRUG

EQ001

Itolizumab \[Bmab 600\]

DRUG

EQ001 Placebo

EQ001 Placebo

Sponsors & Collaborators

  • Biocon Limited

    collaborator INDUSTRY

  • Equillium AUS Pty Ltd

    collaborator UNKNOWN

  • Equillium

    lead INDUSTRY

Principal Investigators

  • Jo A Douglass, MD · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2021-10-12
Completion
2021-10-12

Countries

  • Australia
  • New Zealand

Study Locations

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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 NCT04007198 on ClinicalTrials.gov