AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis
NCT ID: NCT01132612
Last Updated: 2018-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
275 participants
INTERVENTIONAL
2010-05-11
2016-10-18
Brief Summary
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Detailed Description
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The data gathered in this extension study of the core study (CAIN457A2211)was used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The participants in the extension study continued to stay on the exact same treatment regimen they were taking when completing the core study. The extension trial was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks of treatment-free follow-up for participants who did not continue in the extension study. Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus 224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or until the drug was commercially available in the market of the country of participation, whichever occurred first.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fixed-time interval regimen
Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
AIN457
AIN457A 150 mg powder for solution
Placebo
Placebo to AIN457A 150 mg powder for solution
Treatment at start of relapse regimen
Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
AIN457
AIN457A 150 mg powder for solution
Placebo
Placebo to AIN457A 150 mg powder for solution
Open-label
Secukinumab 150 mg sc administered every 4 weeks
AIN457
AIN457A 150 mg powder for solution
Interventions
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AIN457
AIN457A 150 mg powder for solution
Placebo
Placebo to AIN457A 150 mg powder for solution
Eligibility Criteria
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Inclusion Criteria
* Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.
* Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator
* Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Note: Due to new data available from the toxicology studies, the need for male contraception was removed.
Exclusion Criteria
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (\> 5mlU/mL)
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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Little Rock, Arkansas, United States
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Pasadena, California, United States
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San Diego, California, United States
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Newnan, Georgia, United States
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Snellville, Georgia, United States
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Champaign, Illinois, United States
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Springfield, Illinois, United States
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Evansville, Indiana, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Clinton Township, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Rochester, New York, United States
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High Point, North Carolina, United States
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Lake Oswego, Oregon, United States
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Portland, Oregon, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Charlottesville, Virginia, United States
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Nice, , France
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Toulouse, , France
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Berlin, , Germany
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Bonn, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Münster, , Germany
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Tübingen, , Germany
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Kopavogur, , Iceland
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Afula, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Nagoya, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Chitose, Hokkaido, Japan
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Bunkyo-ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Ålesund, , Norway
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Bergen, , Norway
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Oslo, , Norway
Countries
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Other Identifiers
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2009-017234-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2211E1
Identifier Type: -
Identifier Source: org_study_id
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