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

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

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 Overview

• Status: Completed
• Conditions: Lupus Nephritis; Lupus Erythematosus
• Intervention / Treatment: Drug: Itolizumab [Bmab 600]

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Chandigarh, India
    • Post Graduate Institute of Medical Education and Research (PGIMER)
  • Gurugramam, India
    • Medanta - The Medicity Hospital
  • New Delhi, India
    • Max Super Specialty Hospital
  • Puducherry, India
    • Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)
• Poland
  • Warszawa, Poland, 04-749
    • Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ
  • Łódź, Poland, 92-213
    • SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii
• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • AKDHC Medical Research Services, LLC
  • California
    • Chula Vista, California, United States, 91910
      • California Institute of Renal Research
    • La Jolla, California, United States, 92037
      • University of California San Diego Perlman Ambulatory Clinic
  • Florida
    • Clearwater, Florida, United States, 33765-2616
      • Clinical Research of West Florida - Clearwater
    • Fort Lauderdale, Florida, United States, 33309
      • Centre for Rheumatology, Immunology and Arthritis
    • Gainesville, Florida, United States, 32610
      • University of Florida, Division of Rheumatology
    • Leesburg, Florida, United States, 34748
      • Clinical Site Partners Leesburg, LLC
    • Miami, Florida, United States, 33165
      • Hope Clinical Trials
    • Miami, Florida, United States, 33136
      • SouthCoast Research Center Inc
    • Orlando, Florida, United States, 32810
      • Omega Research Maitland, LLC
    • Tampa, Florida, United States, 33606
      • University of South Florida
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida - Tampa
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Georgia Nephrology
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine, Montefiore Medical Center
    • Great Neck, New York, United States, 11021
      • Northwell Health / Division of Rheumatology
    • New York, New York, United States, 10032
      • Columbia University Medical Center, Div of Nephrology
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center, LLC
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Renal Group
    • Houston, Texas, United States, 77054
      • Prolato Clinical Research Center (PCRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Type A Cohort Key Inclusion Criteria:

1. Is male or female, age ≥ 18 and ≤ 75 years
2. 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
3. Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
4. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
5. Restricted SLE treatments are stable and/or washed out
6. During Screening, has adequate hematologic function

Type B Cohort Key Inclusion Criteria:

1. Is male or female, age ≥ 18 and ≤ 75 years
2. Has a diagnosis of SLE
3. Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V)
4. Has a urine protein to creatinine ratio of > 1000 mg/g
5. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment
6. Has adequate hematologic function
7. Restricted SLE treatments are stable and/or washed out
8. Most recent eGFR ≥ 40 mL/min/1.73m2
9. Has evidence of serologic activity

Key Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EQ001 Type A cohort; 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; Other Names: Bmab600; Itolizumab
Experimental: EQ001 for Type B cohort; 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]; EQ001; Other Names: Bmab600; Itolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Characterize the PK of Itolizumab	To characterize the pharmacokinetics of itolizumab	Type A up to Day 57 or Type B up to Day 253
CD6 Receptor Occupancy	the % levels of free versus EQ001-bound CD6 receptor on T cells	Type A up to Day 57 or Type B up to Day 253

Collaborators and Investigators

• Sponsor: Equillium
• Collaborators: Biocon Limited
• Investigators: Principal Investigator: Kenneth Kalunian, MD, UCSD

Publications and helpful links

Helpful Links

• Company website

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus; Active Proliferative Lupus Nephritis
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: EQ001-19-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No