A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3STUDY EVALUATING THE EFFICACY AND SAFETY OF TWO DOSES OF ANIFROLUMAB INADULT SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Not Applicable

• Conditions: -M32 Systemic lupus erythematosus; Systemic lupus erythematosus; M32

• Registration Number: PER-062-15
• Lead Sponsor: AstraZeneca AB,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-04
• Study Completion: 2018-07-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Aged 18 through 70 years at the time of screening
2. Written informed consent and any locally required authorisation (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA, Data PrivacyDirective in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
3. Completion of all screening procedures within 30 days of signing the informed consent form (ICF)
4. Weigh ≥40.0 kg at Screening
5. Adequate peripheral venous Access
6. Diagnosis of paediatric or adult SLE with a diagnosis of SLE according to the ACR 1982 revised criteria (Tan et al, 1982) ≥24 weeks prior to signing the ICF
7. Currently receiving at least 1 of the following:
(a) A dose of oral prednisone (≤40 mg/day) for a minimum of 2 weeks prior to signing of the ICF. The dose of oral prednisone the subject is taking must be stable for a minimum of 2 weeks prior to Week 0 (Day 1)
(b) Any of the following medications administered for a minimum of 12 weeks prior to signing the informed consent, and at a stable dose for a minimum of 8 weeks prior to signing the informed consent and until Day 1:. Please refer to protocol page 33

Exclusion Criteria

Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
2. Concurrent enrolment in another clinical study with an investigational product
3. Individuals involved with the conduct of the study, their employees, or immediate family members of such individuals
4. Lactating or pregnant females or females who intend to become pregnant anytime from initiation of Screening until the 12-week safety follow-up period following last dose of investigational product
5. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1)
6. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period (see Appendix W)
7. Spontaneous or induced abortion, still or live birth, or pregnancy ≤4 weeks prior to signing the ICF
8. At Screening (within 4 weeks before Week 0 [Day 1]), any of the following:
(a) Aspartate aminotransferase (AST) >2.0 × upper limit of normal (ULN).
(b) Alanine aminotransferase (ALT) >2.0 × ULN.
(c) Total bilirubin >ULN (unless due to Gilbert´s syndrome)
Please refer to Protocol page 37

Study & Design

• Study Type: Interventional
• Study Design: Not specified