NCT04128579

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

A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (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 Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

Detailed description

The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 20 open-label subjects enrolled for Type B-Lupus Nephritis. Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product.

Conditions

• Lupus Erythematosus
• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Itolizumab [Bmab 600]	EQ001

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-11-16
• Completion: 2024-01-18
• First posted: 2019-10-16
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

25 sites across 3 countries: United States, India, Poland

Regulatory

• FDA-regulated drug study