CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled / 18 target
Drug / intervention
EQ001 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04007198
NCT04007198Phase 1CompletedUpdate Overdue (0.2/mo)Completion was 56mo ago

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

Biocon Limited·interventional·Posted Jul 5, 2019·Updated Jun 2, 2026

In Brief

A Phase 1 clinical trial evaluating EQ001 and EQ001 Placebo for Asthma. Completed, enrolled 18 participants across 13 sites in 2 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustralia, New Zealand

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartJun 20, 2019
Primary CompletionOct 12, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.0 years ago

Arms & Interventions

EQ001experimental

EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.

Drug: EQ001
EQ001 Placeboplacebo_comparator

Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.

Drug: EQ001 Placebo

Interventions

EQ001drug

Itolizumab \[Bmab 600\]

EQ001 Placebodrug

EQ001 Placebo