Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis (EQUALISE)
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ClinicalTrials.gov Identifier: NCT04128579 |
Recruitment Status :
Recruiting
First Posted : October 16, 2019
Last Update Posted : March 18, 2021
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Condition or disease | Intervention/treatment | Phase |
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Lupus Erythematosus Lupus Nephritis | Drug: Itolizumab [Bmab 600] | Phase 1 |
The study will enroll up to 48 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and 3 dose escalating cohorts of 6 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 (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | cohort based escalation of 6 subjects (Type A and Type B) |
Masking: | None (Open Label) |
Masking Description: | Type A and Type B are open-label. |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | August 2022 |

Arm | Intervention/treatment |
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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).
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Drug: Itolizumab [Bmab 600]
EQ001
Other Names:
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Experimental: EQ001 for Type B cohort
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 13 doses (up to 3 cohorts with dosing to be determined in the range of 0.8 -- 3.2 mg/kg).
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Drug: Itolizumab [Bmab 600]
EQ001
Other Names:
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- Incidence of Treatment Emergent Adverse Events [ Time Frame: Type A Day 57 or Type B Day 253 ]Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Time to maximum EQ001 serum concentration, Tmax [ Time Frame: Type A Day 57 or Type B Day 253 ]Time to maximum EQ001 serum concentration, Tmax
- Maximum EQ001 serum drug concentration, Cmax [ Time Frame: Type A Day 57 or Type B Day 253 ]Maximum EQ001 serum drug concentration, Cmax
- Minimum EQ001 serum drug concentration, Cmin [ Time Frame: Type A Day 57 or Type B Day 253 ]Minimum EQ001 serum drug concentration, Cmin
- Total EQ001 exposure across time, AUC (from zero to infinity) [ Time Frame: Type A Day 57 or Type B Day 253 ]Total EQ001 exposure across time, AUC (from zero to infinity)
- Half life of EQ001, t1/2 [ Time Frame: Type A Day 57 or Type B Day 253 ]Half life of EQ001, t1/2
- Volume of distribution of EQ001, Vd [ Time Frame: Type A Day 57 or Type B Day 253 ]Volume of distribution of EQ001, Vd
- Clearance, Cl [ Time Frame: Type A Day 57 or Type B Day 253 ]Clearance, Cl
- Inflammatory Markers [ Time Frame: Type A Day 57 or Type B Day 253 ]Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein
- CD6 receptor occupancy [ Time Frame: Type A Day 57 or Type B Day 253 ]the % levels of free versus EQ001-bound CD6 receptor on T cells

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- Meets SLICC and/or ACR criteria for 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
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Meets criterion a and/or b
- Has previously completed induction treatment for active proliferative LN and is currently receiving one of the following: mycophenolate mofetil (MMF), mycophenolic acid (MPA), azathioprine or a calcineurin inhibitor.
- Has been receiving induction treatment with MMF/MPA and has a < 50% reduction in proteinuria at or after 12 weeks of induction
- During Screening 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 during Screening
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128579
Contact: Catherine Kim | 858 412 5302 | clinicaltrials@equilliumbio.com |
United States, Arizona | |
AKDHC Medical Research Services, LLC | Recruiting |
Sun City, Arizona, United States, 85351 | |
United States, California | |
University of California San Diego Perlman Ambulatory Clinic | Not yet recruiting |
La Jolla, California, United States, 92037 | |
United States, Florida | |
Clinical Research of West Florida - Clearwater | Recruiting |
Clearwater, Florida, United States, 33765-2616 | |
Centre for Rheumatology, Immunology and Arthritis | Recruiting |
Fort Lauderdale, Florida, United States, 33309 | |
Clinical Site Partners Leesburg, LLC | Recruiting |
Leesburg, Florida, United States, 34748 | |
SouthCoast Research Center Inc | Recruiting |
Miami, Florida, United States, 33136 | |
Hope Clinical Trials | Recruiting |
Miami, Florida, United States, 33165 | |
Omega Research Maitland, LLC | Recruiting |
Orlando, Florida, United States, 32810 | |
Clinical Research of West Florida - Tampa | Recruiting |
Tampa, Florida, United States, 33603 | |
United States, Georgia | |
Georgia Nephrology | Recruiting |
Lawrenceville, Georgia, United States, 30046 | |
United States, New York | |
Albert Einstein College of Medicine, Montefiore Medical Center | Recruiting |
Bronx, New York, United States, 10461 | |
Northwell Health / Division of Rheumatology | Not yet recruiting |
Great Neck, New York, United States, 11021 | |
United States, Texas | |
Prolato Clinical Research Center (PCRC) | Recruiting |
Houston, Texas, United States, 77054 |
Principal Investigator: | Kenneth Kalunian, MD | UCSD |
Responsible Party: | Equillium |
ClinicalTrials.gov Identifier: | NCT04128579 |
Other Study ID Numbers: |
EQ001-19-002 |
First Posted: | October 16, 2019 Key Record Dates |
Last Update Posted: | March 18, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Systemic Lupus Erythematosus Active Proliferative Lupus Nephritis |
Nephritis Lupus Nephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Kidney Diseases Urologic Diseases Glomerulonephritis |