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

NCT04924296 | Unknown Phase 2 FDA Drug

• 1 other identifier: SHR-1314-203
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

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

  at 12 weeks

Secondary Outcomes (7)

• Percentage change of 24 hours UPCR from baseline to Week 24

  from baseline to Week 24

• Percentage change of 24 hours UPCR from Week 12 to Week24

  from Week 12 to Week24

• Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24

  at Week 12 and Week 24

• Percentage of participants achieving renal Complete Response at Week 12 and Week 24

  at Week 12 and Week 24

• Percentage of pts achieving renal Partial Response at Week 12 and Week 24

  at Week 12 and Week 24

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR-1314

Treatment group B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1314 DRUG

SHR-1314 s.c. + Steroids

Treatment group A

Placebo DRUG

Placebo s.c. + Steroids

Treatment group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• h UPCR ≥ 1 at screening.
• h UPR ≥ 1.0 g/d，≤ 3.5 g/d.
• eGFR \> 45ml/min/1.73m2.
• SLEDAI-2K≥8.

You may not qualify if:

• 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..

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yuxian Zhu, M.M

CONTACT

0518-82342973; yuxian.zhu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1314 subcutaneous administration, a multicentre, randomized, double-blind, parallel, placebo-controlled study

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: June 28, 2021
• Primary Completion: December 25, 2021
• Study Completion: September 3, 2022
• Last Updated: June 11, 2021

Record last verified: 2021-05