None listed
Conditions
Interventions
Subjects will receive MEDI-546 1000 mg administered as an IV infusion Q4W starting at Day 1 (Week 0) for
up to 2 years or until the sponsor discontinues development of MEDI-546 for SLE, whichever c
Sponsors
MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including Day 1 evaluations 2) Must have qualified for and received investigational product (MEDI-546 or placebo) and completed the treatment period plus the follow-up period (through Day 422) in Study CD-IA-MEDI-546-1013. Subjects who discontinued from Study CD-IAMEDI- 546-1013 are not eligible for this study. 3) Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception for 28 days prior to Day 1, and must agree to continue using such precautions for 85 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. Subjects must continue the use of their effective contraceptions as used in Study CD-IA-MEDI-546-1013. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. 4) Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 for 85 days after receipt of the final dose of investigational product.
Exclusion criteria
Exclusion criteria: 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) Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period. Exclusion Criteria Related to Concomitant Medications: 3) Receipt of any of the following within the last 12 weeks: • Azathioprine > 200 mg/day. • Mycophenolate mofetil/mycophenolic acid > 2.0 g/day. • Oral, SC, or intramuscular methotrexate > 25 mg/week. 4) Receipt of any of the following: • Any live or attenuated vaccine within 4 weeks prior to signing the ICF (administration of killed vaccines is acceptable, the sponsor recommends investigators ensure all subjects are up to date on required vaccinations prior to study entry). • Bacillus of Calmette and Guerin (BCG) vaccine within 1 year of signing the ICF.
Countries
Brazil, Bulgaria, Colombia, Czech Republic, Hungary, India, Korea South, Mexico, Peru, Poland, Romania, Taiwan, Ukraine, United States
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed