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A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1314
Placebo
Sponsored by
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Chinese adult pts (18-65yr), Male or Female
  2. BMI≥18 kg/m2 and ≤ 35kg/m2
  3. Confirmed diagnosis of LN, renal biopsy report data is within 3-months prior to the date of ICF is first signed

    3.1 Biopsy-proven proliferative lupus nephritis Class III or Class IV, either with or without the presence of Class V, using the 2003 ISN/RPS criteria.

    3.2 24h UPCR ≥ 1 at screening.

    3.3 24h UPR ≥ 1.0 g/d,≤ 3.5 g/d.

    3.4 eGFR > 45ml/min/1.73m2.

  4. SLEDAI-2K≥8.

Exclusion Criteria:

  1. Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE)
  2. Subjects who have previously treated by both CYC and MMF (or other forms of mycophenolate)
  3. With a hHistory of using 60 mg/d prednisolone (or equivalent dose) for more than 3 months prior to Baseline
  4. History of inflammatory bowel disease or have other ongoing active autoimmune diseases
  5. Required management of acute or chronic infections within the past 8 weeks.
  6. At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  7. History of congestive heart failure (New York Heart Association [NYHA] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study.
  8. History of depression and/or suicidal ideation or any suicidal behavior based on an assessment using the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline . The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide
  9. Receipt of any IL-17/IL-17R targeted therapy within the past year.
  10. Those who have participated in any clinical study for any drug or medical device within 3 months before screening.
  11. Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  12. All subjects will be tested for tuberculosis status using IGRA and X-ray test. Subjects with active or latent tuberculosis will be excluded
  13. History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence.
  14. History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence.
  15. Pregnant or nursing..

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment group A

    Treatment group B

    Arm Description

    Outcomes

    Primary Outcome Measures

    percentage change of 24 hours UPCR from baseline to Week 12.

    Secondary Outcome Measures

    Percentage change of 24 hours UPCR from baseline to Week 24
    Percentage change of 24 hours UPCR from Week 12 to Week24
    Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24
    Percentage of participants achieving renal Complete Response at Week 12 and Week 24
    Percentage of pts achieving renal Partial Response at Week 12 and Week 24
    Change in PGA from baseline to Week 12 and Week 24
    Change in SLEDAI-2K from baseline to Week 12 and Week 24

    Full Information

    First Posted
    June 7, 2021
    Last Updated
    June 7, 2021
    Sponsor
    Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04924296
    Brief Title
    A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
    Official Title
    A Multicentre, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of fSHR-1314 in Adult Patients With Lupus Nephritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 28, 2021 (Anticipated)
    Primary Completion Date
    December 25, 2021 (Anticipated)
    Study Completion Date
    September 3, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo. The study will also assess the safety and tolerability of SHR-1314 in the patient population over the study period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lupus Nephritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    SHR-1314 subcutaneous administration, a multicentre, randomized, double-blind, parallel, placebo-controlled study
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group A
    Arm Type
    Experimental
    Arm Title
    Treatment group B
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1314
    Intervention Description
    SHR-1314 s.c. + Steroids
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo s.c. + Steroids
    Primary Outcome Measure Information:
    Title
    percentage change of 24 hours UPCR from baseline to Week 12.
    Time Frame
    at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage change of 24 hours UPCR from baseline to Week 24
    Time Frame
    from baseline to Week 24
    Title
    Percentage change of 24 hours UPCR from Week 12 to Week24
    Time Frame
    from Week 12 to Week24
    Title
    Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24
    Time Frame
    at Week 12 and Week 24
    Title
    Percentage of participants achieving renal Complete Response at Week 12 and Week 24
    Time Frame
    at Week 12 and Week 24
    Title
    Percentage of pts achieving renal Partial Response at Week 12 and Week 24
    Time Frame
    at Week 12 and Week 24
    Title
    Change in PGA from baseline to Week 12 and Week 24
    Time Frame
    from baseline to Week 12 and Week 24
    Title
    Change in SLEDAI-2K from baseline to Week 12 and Week 24
    Time Frame
    from baseline to Week 12 and Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chinese adult pts (18-65yr), Male or Female BMI≥18 kg/m2 and ≤ 35kg/m2 Confirmed diagnosis of LN, renal biopsy report data is within 3-months prior to the date of ICF is first signed 3.1 Biopsy-proven proliferative lupus nephritis Class III or Class IV, either with or without the presence of Class V, using the 2003 ISN/RPS criteria. 3.2 24h UPCR ≥ 1 at screening. 3.3 24h UPR ≥ 1.0 g/d,≤ 3.5 g/d. 3.4 eGFR > 45ml/min/1.73m2. SLEDAI-2K≥8. Exclusion Criteria: Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE) Subjects who have previously treated by both CYC and MMF (or other forms of mycophenolate) With a hHistory of using 60 mg/d prednisolone (or equivalent dose) for more than 3 months prior to Baseline History of inflammatory bowel disease or have other ongoing active autoimmune diseases Required management of acute or chronic infections within the past 8 weeks. At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. History of congestive heart failure (New York Heart Association [NYHA] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study. History of depression and/or suicidal ideation or any suicidal behavior based on an assessment using the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline . The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide Receipt of any IL-17/IL-17R targeted therapy within the past year. Those who have participated in any clinical study for any drug or medical device within 3 months before screening. Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. All subjects will be tested for tuberculosis status using IGRA and X-ray test. Subjects with active or latent tuberculosis will be excluded History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence. History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence. Pregnant or nursing..
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuxian Zhu, M.M
    Phone
    0518-82342973
    Email
    yuxian.zhu@hengrui.com

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis

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