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

Lupus Nephritis Clinical Trial

— EQUALISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04128579
• Other study ID #: EQ001-19-002
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2019
• Est. completion date: January 18, 2024

Study information

• Verified date: February 2024
• Source: Equillium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 18, 2024
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus
• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Itolizumab [Bmab 600]
EQ001

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research (PGIMER)	Chandigarh
India	Medanta - The Medicity Hospital	Gurugramam
India	MAX Super Specialty Hospital	New Delhi
India	Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)	Puducherry
Poland	SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii	Lódz
Poland	Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ	Warszawa
United States	Northeast Clinical Research Center, LLC	Bethlehem	Pennsylvania
United States	Albert Einstein College of Medicine, Montefiore Medical Center	Bronx	New York
United States	California Institute of Renal Research	Chula Vista	California
United States	Clinical Research of West Florida - Clearwater	Clearwater	Florida
United States	Dallas Renal Group	Dallas	Texas
United States	Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	University of Florida, Division of Rheumatology	Gainesville	Florida
United States	Northwell Health / Division of Rheumatology	Great Neck	New York
United States	Prolato Clinical Research Center (PCRC)	Houston	Texas
United States	University of California San Diego Perlman Ambulatory Clinic	La Jolla	California
United States	Georgia Nephrology	Lawrenceville	Georgia
United States	Clinical Site Partners Leesburg, LLC	Leesburg	Florida
United States	Hope Clinical Trials	Miami	Florida
United States	SouthCoast Research Center Inc	Miami	Florida
United States	Columbia University Medical Center, Div of Nephrology	New York	New York
United States	Omega Research Maitland, LLC	Orlando	Florida
United States	AKDHC Medical Research Services, LLC	Sun City	Arizona
United States	Clinical Research of West Florida - Tampa	Tampa	Florida
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Equillium	Biocon Limited

Countries where clinical trial is conducted

United States,  India,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence 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	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
Secondary	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

External Links

•   company website