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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

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

Condition or disease Intervention/treatment Phase
Lupus Erythematosus Lupus Nephritis Drug: Itolizumab [Bmab 600] Drug: EQ001 Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
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
Official Title: 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
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
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).
Drug: Itolizumab [Bmab 600]
EQ001
Other Names:
  • Bmab600
  • Itolizumab

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).
Drug: Itolizumab [Bmab 600]
EQ001
Other Names:
  • Bmab600
  • Itolizumab

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).
Drug: EQ001 Placebo
EQ001 Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Maximum EQ001 serum drug concentration, Cmax [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Maximum EQ001 serum drug concentration, Cmax

  3. Minimum EQ001 serum drug concentration, Cmin [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Minimum EQ001 serum drug concentration, Cmin

  4. 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)

  5. Half life of EQ001, t1/2 [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Half life of EQ001, t1/2

  6. Volume of distribution of EQ001, Vd [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Volume of distribution of EQ001, Vd

  7. Clearance, Cl [ Time Frame: Type A Day 57 or Type B Day 169 ]
    Clearance, Cl

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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

Information from the National Library of Medicine

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


Contacts
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Contact: Catherine Kim 858 412 5302 clinicaltrials@equilliumbio.com

Locations
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United States, Florida
Clinical Research of West Florida - Clearwater Recruiting
Clearwater, Florida, United States, 33765-2616
SouthCoast Research Center Inc Recruiting
Miami, Florida, United States, 33136
Hope Clinical Trials Recruiting
Miami, Florida, United States, 33165
Clinical Research of West Florida - Tampa Recruiting
Tampa, Florida, United States, 33603
Sponsors and Collaborators
Equillium
Biocon Limited
Investigators
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Principal Investigator: Kenneth Kalunian, MD UCSD

Additional Information:
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Responsible Party: Equillium
ClinicalTrials.gov Identifier: NCT04128579     History of Changes
Other Study ID Numbers: EQ001-19-002
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Equillium:
Systemic Lupus Erythematosus
Active Proliferative Lupus Nephritis
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis