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

NCT04128579 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: EQ001-19-002
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 25

Brief 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

Lupus Erythematosus; Lupus Nephritis

Keywords

Systemic Lupus Erythematosus; Active Proliferative Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events

  Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  Type A up to Day 57 or Type B up to Day 253

Secondary Outcomes (2)

• To Characterize the PK of Itolizumab

  Type A up to Day 57 or Type B up to Day 253

• CD6 Receptor Occupancy

  Type A up to Day 57 or Type B up to Day 253

Study Arms (2)

EQ001 Type A cohort

EXPERIMENTAL

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 cohort

EXPERIMENTAL

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

Also known as: Bmab600, Itolizumab

EQ001 Type A cohort; EQ001 for Type B cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female, age ≥ 18 and ≤ 75 years
• Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE
• Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
• Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
• Restricted SLE treatments are stable and/or washed out
• During Screening, has adequate hematologic function
• Is male or female, age ≥ 18 and ≤ 75 years
• Has a diagnosis of SLE
• Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V)
• Has a urine protein to creatinine ratio of \> 1000 mg/g
• Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment
• Has adequate hematologic function
• Restricted SLE treatments are stable and/or washed out
• Most recent eGFR ≥ 40 mL/min/1.73m2
• Has evidence of serologic activity

You may not qualify if:

• Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
• Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
• Active TB or a positive TB test

Sponsors & Collaborators

• Equillium: lead
• Biocon Limited: collaborator

Study Sites (25)

AKDHC Medical Research Services, LLC

Sun City, Arizona, 85351, United States

Location

California Institute of Renal Research

Chula Vista, California, 91910, United States

Location

University of California San Diego Perlman Ambulatory Clinic

La Jolla, California, 92037, United States

Location

Clinical Research of West Florida - Clearwater

Clearwater, Florida, 33765-2616, United States

Location

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

University of Florida, Division of Rheumatology

Gainesville, Florida, 32610, United States

Location

Clinical Site Partners Leesburg, LLC

Leesburg, Florida, 34748, United States

Location

SouthCoast Research Center Inc

Miami, Florida, 33136, United States

Location

Hope Clinical Trials

Miami, Florida, 33165, United States

Location

Omega Research Maitland, LLC

Orlando, Florida, 32810, United States

Location

Clinical Research of West Florida - Tampa

Tampa, Florida, 33603, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Georgia Nephrology

Lawrenceville, Georgia, 30046, United States

Location

Northwell Health / Division of Rheumatology

Great Neck, New York, 11021, United States

Location

Columbia University Medical Center, Div of Nephrology

New York, New York, 10032, United States

Location

Albert Einstein College of Medicine, Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania, 18017, United States

Location

Dallas Renal Group

Dallas, Texas, 75230, United States

Location

Prolato Clinical Research Center (PCRC)

Houston, Texas, 77054, United States

Location

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, India

Location

Medanta - The Medicity Hospital

Gurugramam, India

Location

MAX Super Specialty Hospital

New Delhi, India

Location

Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)

Puducherry, India

Location

SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii

Lodz, 92-213, Poland

Location

Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ

Warsaw, 04-749, Poland

Location

Related Links

• company website

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

itolizumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Equillium, Inc.

clinicaltrials@equilliumbio.com

8582401200

Study Officials

• Kenneth Kalunian, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Type A and Type B are open-label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 16, 2019
• Study Start: October 1, 2019
• Primary Completion: November 16, 2023
• Study Completion: January 18, 2024
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4); PL (2); US (19)