CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled / 52 target
Drug / intervention
Itolizumab [Bmab 600]drug
Likely dose
3.2 mg/kgfrom 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/NCT04128579
NCT04128579Phase 1CompletedMonitor (0.6/mo)Completion was 31mo ago
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A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis

Biocon Limited·interventional·Posted Oct 16, 2019·Updated Jun 4, 2026

In Brief

A Phase 1 clinical trial evaluating Itolizumab [Bmab 600] for Lupus Erythematosus and Lupus Nephritis. Completed, enrolled 52 participants across 25 sites in 3 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Erythematosus, Lupus Nephritis
CountriesIndia, Poland, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 16, 2019
Enrollment StartOct 1, 2019
Primary CompletionNov 16, 2023
Study CompletionJan 18, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.7 years ago

Arms & Interventions

EQ001 Type A cohortexperimental

EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg).

Drug: Itolizumab [Bmab 600]
EQ001 for Type B cohortexperimental

EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).

Drug: Itolizumab [Bmab 600]

Interventions

Itolizumab [Bmab 600]drug

EQ001