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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128579
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : April 21, 2022
Sponsor:
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium

Study Description
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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] Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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.
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 : November 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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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 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg).
 Drug: Itolizumab [Bmab 600]
EQ001
Other Names:
  • Bmab600
  • Itolizumab
Experimental: EQ001 for Type B cohort
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
 Drug: Itolizumab [Bmab 600]
EQ001
Other Names:
  • Bmab600
  • Itolizumab


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: Type A up to Day 57 or Type B up to Day 253 ]
    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. To characterize the PK of itolizumab [ Time Frame: Type A up to Day 57 or Type B up to Day 253 ]
    To characterize the pharmacokinetics of itolizumab

  2. CD6 receptor occupancy [ Time Frame: Type A up to Day 57 or Type B up to Day 253 ]
    the % levels of free versus EQ001-bound CD6 receptor on T cells


Eligibility Criteria
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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. Has a diagnosis of 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. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment
  6. 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

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
Contacts and Locations
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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: Clinical Trial Manager 858 412 5302 clinicaltrials@equilliumbio.com

Locations
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Sponsors and Collaborators
Equillium
Biocon Limited
Investigators
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Principal Investigator: Kenneth Kalunian, MD UCSD
More Information
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Additional Information:

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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: April 21, 2022
Last Verified: April 2022
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