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

  • STATUS
    Recruiting
  • participants needed
    55
  • sponsor
    Equillium
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Updated on 1 December 2021
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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.

Details
Condition Lupus Erythematosus, Lupus Nephritis
Age 18years - 75years
Treatment Itolizumab [Bmab 600]
Clinical Study IdentifierNCT04128579
SponsorEquillium
Last Modified on1 December 2021

Eligibility

 Yes No Not Sure

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
Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease
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

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
Clear my responses
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