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

Not Applicable

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

• Registration Number: PER-038-13
• Lead Sponsor: MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-13
• Study Completion: 2018-02-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified