A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
NCT ID: NCT01438489
Last Updated: 2016-10-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
626 participants
INTERVENTIONAL
2012-01-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anifrolumab (MEDI-546) 300 mg
Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Anifrolumab 300 mg
Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Anifrolumab (MEDI-546) 1000 mg
Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Anifrolumab 1000 mg
Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Matching Placebo
Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
Placebo
Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
Interventions
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Anifrolumab 300 mg
Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Anifrolumab 1000 mg
Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Placebo
Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
* Weight greater than or equal to 40 kg
* Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
* Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
* No evidence of cervical malignancy on Pap smear within 2 years of randomization
* Female participants must be willing to avoid pregnancy
* Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization.
Exclusion Criteria
* Active severe or unstable neuropsychiatric SLE
* Clinically significant active infection including ongoing and chronic infections
* History of human immunodeficiency virus (HIV)
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C
* History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
* Live or attenuated vaccine within 4 weeks prior to screening
* Participants with significant hematologic abnormalities.
18 Years
65 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Warren Greth, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
La Jolla, California, United States
Research Site
La Palma, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palm Desert, California, United States
Research Site
San Leandro, California, United States
Research Site
Upland, California, United States
Research Site
Miami, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Palm Harbor, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Las Cruces, New Mexico, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
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Columbus, Ohio, United States
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Edmond, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Barranquilla, , Colombia
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Bogotá, , Colombia
Research Site
Bucaramanga, , Colombia
Research Site
Chía, , Colombia
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Medellín, , Colombia
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Brno, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Dantoli-Nagpur, , India
Research Site
Hyderabad, , India
Research Site
Mumbai, , India
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New Delhi, , India
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Pune, , India
Research Site
Secunderabad, , India
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Guadalajara, , Mexico
Research Site
León, , Mexico
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México, , Mexico
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Toluca, , Mexico
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Arequipa, , Peru
Research Site
Lima, , Peru
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Krakow, , Poland
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Nadarzyn, , Poland
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Poznan, , Poland
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Brasov, , Romania
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Iași, , Romania
Research Site
Târgu Mureş, , Romania
Research Site
Gwangjin-gu, , South Korea
Research Site
Gwangju, , South Korea
Research Site
Seodaemun-gu, , South Korea
Research Site
Suwon, , South Korea
Research Site
Chiayi City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Donetsk, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Luhansk, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Vinnitsya, , Ukraine
Research Site
Vinnytsia, , Ukraine
Countries
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References
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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Casey KA, Smith MA, Sinibaldi D, Seto NL, Playford MP, Wang X, Carlucci PM, Wang L, Illei G, Yu B, Wang S, Remaley AT, Mehta NN, Kaplan MJ, White WI. Modulation of Cardiometabolic Disease Markers by Type I Interferon Inhibition in Systemic Lupus Erythematosus. Arthritis Rheumatol. 2021 Mar;73(3):459-471. doi: 10.1002/art.41518. Epub 2021 Feb 15.
Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.
Casey KA, Guo X, Smith MA, Wang S, Sinibaldi D, Sanjuan MA, Wang L, Illei GG, White WI. Type I interferon receptor blockade with anifrolumab corrects innate and adaptive immune perturbations of SLE. Lupus Sci Med. 2018 Nov 22;5(1):e000286. doi: 10.1136/lupus-2018-000286. eCollection 2018.
Morand EF, Trasieva T, Berglind A, Illei GG, Tummala R. Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab. Ann Rheum Dis. 2018 May;77(5):706-713. doi: 10.1136/annrheumdis-2017-212504. Epub 2018 Feb 2.
Furie R, Khamashta M, Merrill JT, Werth VP, Kalunian K, Brohawn P, Illei GG, Drappa J, Wang L, Yoo S; CD1013 Study Investigators. Anifrolumab, an Anti-Interferon-alpha Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis Rheumatol. 2017 Feb;69(2):376-386. doi: 10.1002/art.39962.
Other Identifiers
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CD-IA-MEDI-546-1013
Identifier Type: -
Identifier Source: org_study_id
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