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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00657189
Other study ID # MI-CP179
Secondary ID
Status Completed
Phase Phase 2
First received April 9, 2008
Last updated August 5, 2016
Start date July 2008
Est. completion date May 2010

Study information

Verified date August 2016
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.


Description:

The primary objective of this study is to evaluate the safety and tolerability of multiple SC doses of MEDI-545 in subjects ≥ 18 years of age with moderately to severely active SLE despite standard of care.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MEDI-545
100 mg once; SC Placebo × 12 doses on other weeks
MEDI-545
100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
MEDI-545
100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
MEDI-545
100 mg every week × 13 doses
Placebo
SC Placebo every week × 13 doses

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Sponsors (1)

Lead Sponsor Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, Robbie G, Levin R, Berney SM, Chindalore V, Olsen N, Richman L, Le C, Jallal B, White B; Lupus Interferon Skin Activity (LISA) Study Investigators. Safety profile and clinical activity of sifalim — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures. Immediately following the first administration of study drug through Study Day 168. Yes
Secondary A secondary endpoint of this study is to assess certain measures of disease activity including PK, and PD of SC doses of MEDI-545. At Study Day 98 Yes
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