Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis

NCT04128579 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-04-18

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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 Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

Conditions

Interventions

DRUG

Itolizumab [Bmab 600]

EQ001

Sponsors & Collaborators

  • Biocon Limited

    collaborator INDUSTRY
  • Equillium

    lead INDUSTRY

Principal Investigators

  • Kenneth Kalunian, MD · UCSD

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-11-16
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States
  • India
  • Poland

Study Locations

More Related Trials

Entities

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 NCT04128579 on ClinicalTrials.gov