Back to resultsStudy of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis (EQUALISE)
Primary Purpose
Lupus Erythematosus, Lupus Nephritis
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Itolizumab [Bmab 600]
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Active Proliferative Lupus Nephritis
Eligibility Criteria
Type A Cohort Key Inclusion Criteria:
- 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
Type B Cohort Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Sites / Locations
- AKDHC Medical Research Services, LLC
- California Institute of Renal Research
- University of California San Diego Perlman Ambulatory Clinic
- Clinical Research of West Florida - Clearwater
- Centre for Rheumatology, Immunology and Arthritis
- University of Florida, Division of Rheumatology
- Clinical Site Partners Leesburg, LLC
- SouthCoast Research Center Inc
- Hope Clinical Trials
- Omega Research Maitland, LLC
- Clinical Research of West Florida - Tampa
- University of South Florida
- Georgia Nephrology
- Albert Einstein College of Medicine, Montefiore Medical Center
- Northwell Health / Division of Rheumatology
- Columbia University Medical Center, Div of Nephrology
- Northeast Clinical Research Center, LLC
- Dallas Renal Group
- Prolato Clinical Research Center (PCRC)
- Post Graduate Institute of Medical Education and Research (PGIMER)
- Medanta - The Medicity Hospital
- MAX Super Specialty Hospital
- Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)
- Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ
- SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EQ001 Type A cohort
EQ001 for Type B cohort
Arm Description
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).
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To characterize the PK of itolizumab
To characterize the pharmacokinetics of itolizumab
CD6 receptor occupancy
the % levels of free versus EQ001-bound CD6 receptor on T cells
Full Information
NCT ID
NCT04128579
First Posted
September 30, 2019
Last Updated
June 15, 2023
Sponsor
Equillium
Collaborators
Biocon Limited
1. Study Identification
Unique Protocol Identification Number
NCT04128579
Brief Title
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Equillium
Collaborators
Biocon Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Lupus Nephritis
Keywords
Systemic Lupus Erythematosus, Active Proliferative Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B)
Masking
None (Open Label)
Masking Description
Type A and Type B are open-label.
Allocation
Non-Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EQ001 Type A cohort
Arm Type
Experimental
Arm Description
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).
Arm Title
EQ001 for Type B cohort
Arm Type
Experimental
Arm Description
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Intervention Type
Drug
Intervention Name(s)
Itolizumab [Bmab 600]
Other Intervention Name(s)
Bmab600, Itolizumab
Intervention Description
EQ001
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
Type A up to Day 57 or Type B up to Day 253
Secondary Outcome Measure Information:
Title
To characterize the PK of itolizumab
Description
To characterize the pharmacokinetics of itolizumab
Time Frame
Type A up to Day 57 or Type B up to Day 253
Title
CD6 receptor occupancy
Description
the % levels of free versus EQ001-bound CD6 receptor on T cells
Time Frame
Type A up to Day 57 or Type B up to Day 253
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Type A Cohort Key Inclusion Criteria:
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
Type B Cohort Key Inclusion Criteria:
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
Key Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Kalunian, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKDHC Medical Research Services, LLC
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
California Institute of Renal Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
University of California San Diego Perlman Ambulatory Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Clinical Research of West Florida - Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765-2616
Country
United States
Facility Name
Centre for Rheumatology, Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
University of Florida, Division of Rheumatology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Clinical Site Partners Leesburg, LLC
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
SouthCoast Research Center Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Hope Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Omega Research Maitland, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Clinical Research of West Florida - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Georgia Nephrology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Albert Einstein College of Medicine, Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Northwell Health / Division of Rheumatology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Columbia University Medical Center, Div of Nephrology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Dallas Renal Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Prolato Clinical Research Center (PCRC)
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Post Graduate Institute of Medical Education and Research (PGIMER)
City
Chandigarh
Country
India
Facility Name
Medanta - The Medicity Hospital
City
Gurugramam
Country
India
Facility Name
MAX Super Specialty Hospital
City
New Delhi
Country
India
Facility Name
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)
City
Puducherry
Country
India
Facility Name
Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://equilliumbio.com/
Description
company website
Learn more about this trial
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
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