AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
NCT ID: NCT00941031
Last Updated: 2015-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
404 participants
INTERVENTIONAL
2009-07-31
2010-12-31
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
DOUBLE
Study Groups
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Induction Single Dose
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
AIN457
Induction Monthly Dose
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
AIN457A
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
Induction Early Loading Dose
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
AIN457A
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Placebo
Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9
Interventions
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AIN457
AIN457A
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
AIN457A
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
Placebo
Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
* At time of randomization, moderate to severe psoriasis as defined by:
* PASI score of 12 or greater and
* IGA score of 3 or greater and
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater
* At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:
* topical treatment and/or
* phototherapy and/or
* previous systemic therapy
Exclusion Criteria
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
* Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
* Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
* Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
* Known immunosuppression (e.g., AIDS) at screening and / or randomization
* History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
* Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
* At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
* History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
* Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
* Pregnant or nursing (lactating) women
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
Novartis Investigative Site
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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Boston, Massachusetts, United States
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Clinton Twp., 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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New York, New York, 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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Philadelphia, Pennsylvania, 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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Lynchburg, Virginia, United States
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Toulouse, France, France
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Nice, , 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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Leipzig, , 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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References
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Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. doi: 10.1111/jdv.12359. Epub 2014 Jan 7.
Other Identifiers
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2008-007525-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2211
Identifier Type: -
Identifier Source: org_study_id
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