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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 : October 16, 2019
Sponsor:
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium

Tracking Information
First Submitted Date  ICMJE September 30, 2019
First Posted Date  ICMJE October 16, 2019
Last Update Posted Date October 16, 2019
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
Incidence of Treatment Emergent Adverse Events [ Time Frame: Type A Day 57 or Type B Day 169 ]
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • Time to maximum EQ001 serum concentration, Tmax [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Time to maximum EQ001 serum concentration, Tmax
  • Maximum EQ001 serum drug concentration, Cmax [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Maximum EQ001 serum drug concentration, Cmax
  • Minimum EQ001 serum drug concentration, Cmin [ Time Frame: Type A Day 57 or Type B Day 169 ]
    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 169 ]
    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 169 ]
    Half life of EQ001, t1/2
  • Volume of distribution of EQ001, Vd [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Volume of distribution of EQ001, Vd
  • Clearance, Cl [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Clearance, Cl
  • Inflammatory Markers [ Time Frame: Type A Day 57 or Type B Day 169 ]
    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 169 ]
    the % levels of free versus EQ001-bound CD6 receptor on T cells
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Official Title  ICMJE A Phase 1b Randomized, Double-blind, Placebo-controlled, Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
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 up to 56 subjects, with up to 4 dose escalating cohorts of either 6 open-label (Type A-SLE) or 8 double-blind (Type B-Lupus Nephritis) subjects (enrolled in a 3:1 ratio). Subjects will receive itolizumab (Type A) or blinded itolizumab or placebo (Type B) administered subcutaneously every two weeks for a total of either 2 or 7 doses with 4 or 12 weeks of follow-up after the last dose of investigational product.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
cohort based escalation of either 6 (Type A) or 8 (Type B) subjects
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Type A is open-label. For Type B, there will be a designated unblinded individual (e.g. pharmacist) for drug preparation. Relevant vendors including PK will be unblinded.
Primary Purpose: Treatment
Condition  ICMJE
  • Lupus Erythematosus
  • Lupus Nephritis
Intervention  ICMJE
  • Drug: Itolizumab [Bmab 600]
    EQ001
    Other Names:
    • Bmab600
    • Itolizumab
  • Drug: EQ001 Placebo
    EQ001 Placebo
Study Arms  ICMJE
  • 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 4 cohorts with dosing to be determined in the range of 0.4 -- 2.4 mg/kg).
    Intervention: Drug: Itolizumab [Bmab 600]
  • Experimental: EQ001 for Type B cohort
    EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 7 doses (up to 4 cohorts with dosing to be determined in the range of 0.4 -- 2.4 mg/kg).
    Intervention: Drug: Itolizumab [Bmab 600]
  • Placebo Comparator: EQ001 Placebo for Type B cohort
    Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 7 doses (up to 4 cohorts with dosing to be determined in the range of 0.4 -- 2.4 mg/kg).
    Intervention: Drug: EQ001 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2019)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Meets SLICC and/or ACR criteria for 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. Meets criterion a and/or b

    1. 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.
    2. Has been receiving induction treatment with MMF/MPA and has a < 50% reduction in proteinuria at or after 12 weeks of induction
  6. During Screening 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 during Screening

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine Kim 858 412 5302 clinicaltrials@equilliumbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04128579
Other Study ID Numbers  ICMJE EQ001-19-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Equillium
Study Sponsor  ICMJE Equillium
Collaborators  ICMJE Biocon Limited
Investigators  ICMJE
Principal Investigator: Kenneth Kalunian, MD UCSD
PRS Account Equillium
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP