AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
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ClinicalTrials.gov Identifier: NCT00941031 |
Recruitment Status :
Completed
First Posted : July 17, 2009
Results First Posted : March 27, 2015
Last Update Posted : August 20, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Tracking Information | ||||
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First Submitted Date ICMJE | July 16, 2009 | |||
First Posted Date ICMJE | July 17, 2009 | |||
Results First Submitted Date ICMJE | January 30, 2015 | |||
Results First Posted Date ICMJE | March 27, 2015 | |||
Last Update Posted Date | August 20, 2015 | |||
Study Start Date ICMJE | July 2009 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. [ Time Frame: 13 weeks ] Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
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Original Primary Outcome Measures ICMJE |
To evaluate the efficacy of three induction regimens of AIN457 administered subcutaneously in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement after 12 weeks of treatment, compared to placebo. [ Time Frame: 12 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis | |||
Brief Summary | The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Plaque-type Psoriasis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
404 | |||
Original Estimated Enrollment ICMJE |
396 | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, Germany, Iceland, Israel, Japan, Norway, United States | |||
Removed Location Countries | Finland, Netherlands | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00941031 | |||
Other Study ID Numbers ICMJE | CAIN457A2211 2008-007525-39 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Original Responsible Party | External Affairs, Novartis Pharmaceuticals | |||
Current Study Sponsor ICMJE | Novartis Pharmaceuticals | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |