Lupus NephritisPhase 2NCT04924296
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
A Phase 2 study testing SHR-1314 in people with Lupus Nephritis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- SHR-1314
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2021to 3 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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..
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Lupus Nephritis
- Being tested
- SHR-1314, Placebo
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Drug
SHR-1314 s.c. + Steroids
PlaceboDrug
Placebo s.c. + Steroids
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-1314 |
| Treatment group B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change of 24 hours UPCR from baseline to Week 12.
Measured: at 12 weeks
Secondary outcomes (7)
Percentage change of 24 hours UPCR from baseline to Week 24
Measured: from baseline to Week 24
Percentage change of 24 hours UPCR from Week 12 to Week24
Measured: from Week 12 to Week24
Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24
Measured: at Week 12 and Week 24
Percentage of participants achieving renal Complete Response at Week 12 and Week 24
Measured: at Week 12 and Week 24
Percentage of pts achieving renal Partial Response at Week 12 and Week 24
Measured: at Week 12 and Week 24
Change in PGA from baseline to Week 12 and Week 24
Measured: from baseline to Week 12 and Week 24
Change in SLEDAI-2K from baseline to Week 12 and Week 24
Measured: from baseline to Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start28 Jun 2021 (estimated)
- Primary completion25 Dec 2021 (estimated)
- Study completion3 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1314 subcutaneous administration, a multicentre, randomized, double-blind, parallel, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924296
- Sponsor's protocol ID
- SHR-1314-203
- Status last verified
- May 2021
- First submitted
- 7 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04924296
- Acronym / sponsor ID
- SHR-1314-203
- Conditions
- Lupus Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (estimated)
- Primary completion
- 25 Dec 2021 (estimated)
- Study completion
- 3 Sep 2022 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1314 subcutaneous administration, a multicentre, randomized, double-blind, parallel, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1314 |
| Treatment group B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1314SHR-1314 s.c. + Steroids | Drug | Treatment group A |
| PlaceboPlacebo s.c. + Steroids | Drug | Treatment group B |
Primary outcome
percentage change of 24 hours UPCR from baseline to Week 12.
Time frame: at 12 weeks
7 secondary outcomes
Percentage change of 24 hours UPCR from baseline to Week 24
Time frame: from baseline to Week 24
Percentage change of 24 hours UPCR from Week 12 to Week24
Time frame: from Week 12 to Week24
Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24
Time frame: at Week 12 and Week 24
Percentage of participants achieving renal Complete Response at Week 12 and Week 24
Time frame: at Week 12 and Week 24
Percentage of pts achieving renal Partial Response at Week 12 and Week 24
Time frame: at Week 12 and Week 24
Change in PGA from baseline to Week 12 and Week 24
Time frame: from baseline to Week 12 and Week 24
Change in SLEDAI-2K from baseline to Week 12 and Week 24
Time frame: from baseline to Week 12 and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1314 in people with Lupus Nephritis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxian Zhu, M.M (0518-82342973, yuxian.zhu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage change of 24 hours UPCR from baseline to Week 12. (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.