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AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT01132612
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : December 5, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Plaque-type Psoriasis
Interventions: Drug: AIN457
Drug: Placebo

  Participant Flow

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
Participants continued their regimens as assigned in CAIN457A2211 (NCT00941031) and were enrolled into one of the following: fixed time interval regimen (FI), treatment at start of relapse regimen (SR) or open-label (OL). There were no more placebo treated patients at the end of the core. Therefore, there is no placebo arm in the extension.

Reporting Groups
  Description
Fixed-time Interval Regimen Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
Treatment at Start of Relapse Regimen Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
Open-label Secukinumab 150 mg sc administered every 4 weeks.

Participant Flow:   Overall Study
    Fixed-time Interval Regimen   Treatment at Start of Relapse Regimen   Open-label
STARTED   46   42   187 
COMPLETED   6   7   17 
NOT COMPLETED   40   35   170 
Death                0                0                1 
Protocol deviation                0                0                3 
Lost to Follow-up                2                2                7 
Adverse Event                5                2                15 
Withdrawal by Subject                5                8                19 
Administrative problems                5                1                52 
Lack of Efficacy                23                22                73 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Fixed-time Interval Regimen Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
Treatment at Start of Relapse Regimen Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
Open-label Secukinumab 150 mg sc administered every 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Fixed-time Interval Regimen   Treatment at Start of Relapse Regimen   Open-label   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   42   187   275 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.0  (13.71)   39.9  (12.12)   45.0  (11.78)   43.9  (12.27) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      15  32.6%      12  28.6%      39  20.9%      66  24.0% 
Male      31  67.4%      30  71.4%      148  79.1%      209  76.0% 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events, Serious Adverse Events and Deaths   [ Time Frame: up to week 351 ]

2.  Secondary:   Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response   [ Time Frame: Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301) ]

3.  Secondary:   Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial   [ Time Frame: up to week 351 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT01132612     History of Changes
Other Study ID Numbers: CAIN457A2211E1
2009-017234-51 ( EudraCT Number )
First Submitted: May 19, 2010
First Posted: May 28, 2010
Results First Submitted: October 17, 2017
Results First Posted: December 5, 2017
Last Update Posted: January 4, 2018