None listed
Conditions
Interventions
Subjects will receive either a fixed intravenous dose of 300 mg anifrolumab every 4 weeks for up to 39 doses (Week 0 to Week 152) or placebo. Investigational product will be administered as an intrave
Sponsors
AstraZeneca AB,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects should fulfil the following criteria: 1. Subjects who have qualified for and received investigational product (anifrolumabor placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52) 2. Written informed consent and any locally required authorisation (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA, Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including Day 1 evaluations 3. Adequate peripheral venous access 4. Females of childbearing potential must use 2 effective methods of avoiding pregnancy, 1 of which is a barrier method, from Day 1/Visit 1 until 12 weeks after the final dose of investigational product unless the subject is surgically sterile (ie,bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), has a sterile male partner, is 1 year postmenopausal, or practices abstinence. Cessation of birth control after the 12-week follow-up period should be discussed with a responsible physician.  Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.  Postmenopausal is defined as at least 1 year since last menses and the subject has an elevated follicle-stimulating hormone (FSH) level greater than the central laboratory value of post-menopausal at Day 1/Visit 1. Nonsterilised males who are sexually active with a female partner of childbearing potential must use a condom (with spermicide where commercially available) from Day 1/Visit 1 until at least 12 weeks after receipt of the final dose of investigational product. 6. Females with an intact cervix should have documentation of a Pap smear with no documented malignancy (eg, cervical intraepithelial neoplasia grade III [CIN III], carcinoma in situ [CIS], or adenocarcinoma in situ [AIS]) within 90 days before Day 1/Visit 1 (see Appendix N). 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 are followed. 7. Willing to forego other forms of experimental treatment during the study 8. Meets the following TB criteria: (a) Negative QuantiFERON®-TB Gold [QFT-G] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005 OR Newly positive QFT-G test result for TB obtained at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must initiate treatment for latent TB within 30 days of randomisation, but prior to the second dose of investigational product administration (Visit 2/Week 4). This should be reported as an AESI. OR (c) Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. The subject must have been diagnosed with latent TB and must have documentation confirming completion of appropriate treatment OR initiate treatment for latent TB within 30 days of randomisation, but prior to the second dos
Exclusion criteria
Exclusion criteria: Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 3.2.1 General exclusion criteria 1. 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. Pregnant females or females who intend to become pregnant anytime from randomisation until the end of the 12-week safety follow-up period following last dose of investigational product 4. Current alcohol, drug, or chemical abuse 3.2.2 Exclusion criteria related to concomitant medications 5. Receipt of any of the following within the last 60 days prior to Day 1/Visit 1: (a) Azathioprine >200 mg/day (b) Mycophenolate mofetil/mycophenolic acid >2.0 g/day (c) Oral, subcutaneous, or intramuscular methotrexate >25 mg/week (d) Mizoribine >150 mg/day 6. 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 7. Receipt of any commercially available biologic agent within 5 half-lives prior to Day 1/Visit 1 8. Receipt of any of the following: (a) Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required vaccinations, including influenza [inactivated/recombinant] vaccine prior to study entry) (b) Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1 3.2.3 Exclusion criteria related to systemic lupus erythematosus and other diseases 9. Active severe SLE-driven renal or neuropsychiatric disease where, in the opinion of the Principal Investigator, protocol-specified SOC is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated 3.2.4 Exclusion criteria related to infection and malignancy risk factors 10. Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection. An HIV test confirmed by the central laboratory must be performed if not done in Studies D3461C00004 or D3461C00005. The result should be available within 30 days of randomisation, but prior to the second dose of investigational product administration (Visit 2/Week 4). 11. 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 (LLOQ) as per the central laboratory. 12. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea South, Lithuania, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kindgdom, United States
Contacts
Public ContactGino Mejia
RPS PERU S.A.C
Outcome results
None listed