A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
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ClinicalTrials.gov Identifier: NCT01071252 |
Recruitment Status :
Completed
First Posted : February 19, 2010
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Chronic Plaque-type Psoriasis |
Interventions |
Drug: AIN457 Drug: Placebo |
Enrollment | 125 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo |
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AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
Period Title: Overall Study | |||||
Started | 29 | 26 | 21 | 27 | 22 |
Completed | 14 | 16 | 17 | 20 | 11 |
Not Completed | 15 | 10 | 4 | 7 | 11 |
Reason Not Completed | |||||
unsatisfactory therapeutic effect | 4 | 6 | 2 | 0 | 6 |
Withdrawal by Subject | 8 | 2 | 1 | 2 | 3 |
administrative problems | 1 | 1 | 0 | 2 | 1 |
Lost to Follow-up | 1 | 0 | 1 | 2 | 0 |
Adverse Event | 1 | 1 | 0 | 1 | 0 |
Death | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo | Total | |
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AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Total of all reporting groups | |
Overall Number of Baseline Participants | 29 | 26 | 21 | 27 | 22 | 125 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 29 participants | 26 participants | 21 participants | 27 participants | 22 participants | 125 participants | |
46.1 (12.65) | 46.3 (13.43) | 45.8 (12.36) | 45.4 (11.64) | 45.9 (10.88) | 45.9 (12.07) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 29 participants | 26 participants | 21 participants | 27 participants | 22 participants | 125 participants | |
Female |
9 31.0%
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4 15.4%
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7 33.3%
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6 22.2%
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8 36.4%
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34 27.2%
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Male |
20 69.0%
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22 84.6%
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14 66.7%
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21 77.8%
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14 63.6%
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91 72.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis Pharmaceuticals |
Phone: | 862-778-8300 |
Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
ClinicalTrials.gov Identifier: | NCT01071252 |
Other Study ID Numbers: |
CAIN457A2220 2009-016807-42 |
First Submitted: | February 18, 2010 |
First Posted: | February 19, 2010 |
Results First Submitted: | January 28, 2015 |
Results First Posted: | February 16, 2015 |
Last Update Posted: | February 16, 2015 |