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

Phase 1

Completed

• Conditions: Lupus Erythematosus; Lupus Nephritis
• Interventions: Drug: Itolizumab [Bmab 600]

• Registration Number: NCT04128579
• Lead Sponsor: Equillium

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

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 Timeline

• Study First Submitted: 2019-09-30
• Study Start: 2019-10-01
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Primary Completion: 2023-11-16
• Study Completion: 2024-01-18
• Results First Submitted: 2025-03-06
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Results First Posted: 2025-04-18
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EQ001 for Type B cohort	Itolizumab [Bmab 600]	EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
EQ001 Type A cohort	Itolizumab [Bmab 600]	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).

Primary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events	Type A up to Day 57 or Type B up to Day 253	Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary Outcome Measures

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

Trial Locations

Locations (25)

Northwell Health / Division of Rheumatology; 🇺🇸 Great Neck, New York, United States

Omega Research Maitland, LLC; 🇺🇸 Orlando, Florida, United States

AKDHC Medical Research Services, LLC; 🇺🇸 Sun City, Arizona, United States

University of California San Diego Perlman Ambulatory Clinic; 🇺🇸 La Jolla, California, United States

Centre for Rheumatology, Immunology and Arthritis; 🇺🇸 Fort Lauderdale, Florida, United States

Georgia Nephrology; 🇺🇸 Lawrenceville, Georgia, United States

Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ; 🇵🇱 Warszawa, Poland

MAX Super Specialty Hospital; 🇮🇳 New Delhi, India

Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER); 🇮🇳 Puducherry, India

Dallas Renal Group; 🇺🇸 Dallas, Texas, United States

Prolato Clinical Research Center (PCRC); 🇺🇸 Houston, Texas, United States

SouthCoast Research Center Inc; 🇺🇸 Miami, Florida, United States

Hope Clinical Trials; 🇺🇸 Miami, Florida, United States

Clinical Research of West Florida - Tampa; 🇺🇸 Tampa, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Northeast Clinical Research Center, LLC; 🇺🇸 Bethlehem, Pennsylvania, United States

Clinical Site Partners Leesburg, LLC; 🇺🇸 Leesburg, Florida, United States

California Institute of Renal Research; 🇺🇸 Chula Vista, California, United States

Columbia University Medical Center, Div of Nephrology; 🇺🇸 New York, New York, United States

SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii; 🇵🇱 Łódź, Poland

Post Graduate Institute of Medical Education and Research (PGIMER); 🇮🇳 Chandigarh, India

Medanta - The Medicity Hospital; 🇮🇳 Gurugramam, India

Clinical Research of West Florida - Clearwater; 🇺🇸 Clearwater, Florida, United States

University of Florida, Division of Rheumatology; 🇺🇸 Gainesville, Florida, United States

Albert Einstein College of Medicine, Montefiore Medical Center; 🇺🇸 Bronx, New York, United States