A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF ANIFROLUMAB IN ADULT SUBJECTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITIS

Not Applicable

• Conditions: -M328 Other forms of systemic lupus erythematosus; Other forms of systemic lupus erythematosus; M328

• Registration Number: PER-074-15
• Lead Sponsor: AstraZeneca AB,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-08
• Study Completion: 2020-08-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. In the opinion of the investigator, must be able to understand the informed consent form (ICF), and all protocol-related subject assessments 2. Fulfils at least 4 of the 11 ACR classification criteria for SLE (see Appendix D), one of which must be: (a) Positive antinuclear antibody (ANA) test (1:40 or higher) at screening by immunofluorescence assay at central laboratory; or (b) (Elevated anti-dsDNA or anti-Sm antibody at screening as determined by central laboratory Clinical criteria may have been present by history if documented in the medical record. Laboratory values specified above must be determined to be positive at screening. 3. Diagnosis of proliferative LN based on a renal biopsy obtained within 12 weeks
prior to signing the ICF or during the screening period: - Class III (±class V) or class IV (±class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification (based on local evaluation of renal biopsy) 4. Urine protein to creatinine ratio >1 gm/gm, obtained on a 24-hour urine collection at both: - The start of screening and - Between Day -14 and -7 of expected date of randomization FOR MORE INFORMATION PLEASE SEE PROTOCOL

Exclusion Criteria

1. Known intolerance to ≤1.5 gm/day of MMF 2. Lactating or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of screening through the 12-week safety follow-up period following last dose of investigational product 3. A diagnosis of pure Class V membranous LN. This will be based on the renal
biopsy obtained within 12 weeks prior to signing ICF or during the screening period 4. History of dialysis within 12 months prior to signing the ICF or expected need for
renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment 5. History of, or current renal diseases (other than LN) that in the opinion of the
Investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy) FOR MORE INFORMATION PLEASE SEE PROTOCOL

Study & Design

• Study Type: Interventional
• Study Design: Not specified