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

Lupus Nephritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04924296
• Other study ID #: SHR-1314-203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 28, 2021
• Est. completion date: September 3, 2022

Study information

• Verified date: May 2021
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Yuxian Zhu, M.M
• Phone: 0518-82342973
• Email: yuxian.zhu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 3, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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..

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• SHR-1314
SHR-1314 s.c. + Steroids
• Placebo
Placebo s.c. + Steroids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage change of 24 hours UPCR from baseline to Week 12.		at 12 weeks
Secondary	Percentage change of 24 hours UPCR from baseline to Week 24		from baseline to Week 24
Secondary	Percentage change of 24 hours UPCR from Week 12 to Week24		from Week 12 to Week24
Secondary	Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24		at Week 12 and Week 24
Secondary	Percentage of participants achieving renal Complete Response at Week 12 and Week 24		at Week 12 and Week 24
Secondary	Percentage of pts achieving renal Partial Response at Week 12 and Week 24		at Week 12 and Week 24
Secondary	Change in PGA from baseline to Week 12 and Week 24		from baseline to Week 12 and Week 24
Secondary	Change in SLEDAI-2K from baseline to Week 12 and Week 24		from baseline to Week 12 and Week 24