A PHASE 2, OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY OF MEDI-546 IN ADULTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,0 个研究点目标入组 40 人开始时间: 2014年1月13日最近更新: 2023年9月4日

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•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.

•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

发起方

MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,