Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01537432
First received: February 17, 2012
Last updated: December 1, 2015
Last verified: November 2015
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Psoriasis, Plaque-type Psoriasis
Interventions: Drug: secukinumab
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AIN457 300mg AIN457 300mg subcutaneously weekly
Placebo Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.

Participant Flow:   Overall Study
    AIN457 300mg     Placebo  
STARTED     24     12  
COMPLETED     18     10  
NOT COMPLETED     6     2  
Lost to Follow-up                 3                 1  
Withdrawal by Subject                 0                 1  
Administrative problems                 1                 0  
Adverse Event                 1                 0  
Unsatisfactory therapeutic effect                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
AIN457 300mg AIN457 300mg subcutaneously weekly
Placebo Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
Total Total of all reporting groups

Baseline Measures
    AIN457 300mg     Placebo     Total  
Number of Participants  
[units: participants]
  24     12     36  
Age  
[units: years]
Mean (Standard Deviation)
  47.5  (14.0)     50.3  (13.8)     48.4  (13.8)  
Gender  
[units: participants]
     
Female     7     6     13  
Male     17     6     23  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52   [ Time Frame: Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01537432     History of Changes
Other Study ID Numbers: CAIN457A2223
Study First Received: February 17, 2012
Results First Received: December 1, 2015
Last Updated: December 1, 2015
Health Authority: United States: Food and Drug Administration