A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled extension study to characterising the long term safety and tolerability of of an intravenous treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or D3461C00005) through the 52-week double-blind treatment period.
Inclusion Criteria:
Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
Adequate peripheral venous access
Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.
Meets the following TB criteria:
In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments
Exclusion Criteria:
Receipt of any of the following within the last 60 days:
Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater
Receipt of any of the following:
Active severe SLE-driven renal or neuropsychiatric disease
Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.
Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
Mainz Am Rhein, 55131, Germany
Kitakyushu-shi, 807-8556, Japan
Kurashiki-shi, 710-8522, Japan
Meguro-ku, 152-8902, Japan
Meguro-ku, 153-8515, Japan
Omura-shi, 856-8562, Japan
Sasebo-shi, 857-1195, Japan
Shinjuku-ku, 160-8582, Japan
Servilla, 41014, Spain