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
About this trial
This is an interventional treatment trial for Lupus Nephritis
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..
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
NCT ID
NCT04924296
First Posted
June 7, 2021
Last Updated
June 7, 2021
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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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