A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01071252
First received: February 18, 2010
Last updated: February 12, 2015
Last verified: February 2015
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Plaque-type Psoriasis
Interventions: Drug: AIN457
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AIN457 1x25mg AIN457 25mg Subcutaneously as a single dose
AIN457 3x25mg AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x75mg AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x150mg AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Placebo Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)

Participant Flow:   Overall Study
    AIN457 1x25mg     AIN457 3x25mg     AIN457 3x75mg     AIN457 3x150mg     Placebo  
STARTED     29     26     21     27     22  
COMPLETED     14     16     17     20     11  
NOT COMPLETED     15     10     4     7     11  
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
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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 1x25mg AIN457 25mg Subcutaneously as a single dose
AIN457 3x25mg AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x75mg AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x150mg AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Placebo Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Total Total of all reporting groups

Baseline Measures
    AIN457 1x25mg     AIN457 3x25mg     AIN457 3x75mg     AIN457 3x150mg     Placebo     Total  
Number of Participants  
[units: participants]
  29     26     21     27     22     125  
Age  
[units: years]
Mean (Standard Deviation)
  46.1  (12.65)     46.3  (13.43)     45.8  (12.36)     45.4  (11.64)     45.9  (10.88)     45.9  (12.07)  
Gender  
[units: participants]
           
Female     9     4     7     6     8     34  
Male     20     22     14     21     14     91  



  Outcome Measures
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1.  Primary:   Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13   [ Time Frame: week 13 ]

2.  Secondary:   Percentage of Participants With Investigator’s Global Assessment (IGA) Response   [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]

3.  Secondary:   Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)   [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]

4.  Secondary:   To Assess the Time to Relapse   [ Time Frame: 37 weeks ]


  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


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01071252     History of Changes
Other Study ID Numbers: CAIN457A2220, 2009-016807-42
Study First Received: February 18, 2010
Results First Received: January 28, 2015
Last Updated: February 12, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Iceland: Icelandic Medicines Control Agency
Estonia: The State Agency of Medicine
Latvia: Agency of Medicines
Japan: Pharmaceuticals and Medical Devices Agency