Clinical trial NCT04128579: Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Official title: A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus Erythematosus
Lupus Nephritis
Keywords: Systemic Lupus Erythematosus
Active Proliferative Lupus Nephritis
Lead sponsor: Equillium
Sponsor class: INDUSTRY
Collaborators: name: Biocon Limited
First posted: 2019-10-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events
timeFrame: Type A up to Day 57 or Type B up to Day 253
Secondary outcomes:
measure: To Characterize the PK of Itolizumab
timeFrame: Type A up to Day 57 or Type B up to Day 253
measure: CD6 Receptor Occupancy
timeFrame: Type A up to Day 57 or Type B up to Day 253
Other outcomes:
Locations:
city: Sun City
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Chula Vista
country: United States
facility: California Institute of Renal Research
state: California
city: La Jolla
country: United States
facility: University of California San Diego Perlman Ambulatory Clinic
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida - Clearwater
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Gainesville
country: United States
facility: University of Florida, Division of Rheumatology
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners Leesburg, LLC
state: Florida
city: Miami
country: United States
facility: SouthCoast Research Center Inc
state: Florida
city: Miami
country: United States
facility: Hope Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Omega Research Maitland, LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida - Tampa
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Lawrenceville
country: United States
facility: Georgia Nephrology
state: Georgia
city: Bronx
country: United States
facility: Albert Einstein College of Medicine, Montefiore Medical Center
state: New York
city: Great Neck
country: United States
facility: Northwell Health / Division of Rheumatology
state: New York
city: New York
country: United States
facility: Columbia University Medical Center, Div of Nephrology
state: New York
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center, LLC
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Renal Group
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center (PCRC)
state: Texas
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research (PGIMER)
city: Gurugramam
country: India
facility: Medanta - The Medicity Hospital
city: New Delhi
country: India
facility: MAX Super Specialty Hospital
city: Puducherry
country: India
facility: Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)
city: Warszawa
country: Poland
facility: Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ
city: Łódź
country: Poland
facility: SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii
Study officials:
affiliation: UCSD
name: Kenneth Kalunian, MD
role: PRINCIPAL_INVESTIGATOR
References: