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Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01412944
First received: August 5, 2011
Last updated: March 17, 2015
Last verified: March 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: Plaque-type Psoriasis
Interventions: Drug: secukinumab 150mg
Drug: secukinumab 10mg/kg i.v. regimen

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study consisted of 3 study periods: I.V. (I.V. infusion and subcutaneous (s.c.) regimens given in a double-blind fashion), Maintenance and follow-up. Participants, who were identified as partial responders at week 12 of study CAIN457A2304 (NCT01406938), were eligible to roll into CAIN457A2307.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants of the CAIN457A2304 150 mg or AIN457 300 mg treatment groups, who were partial responders at week 12 of CAIN457A2304, were randomized in a 1:1 ratio to the AIN457 300 mg s.c. or AIN457 10 mg/kg I.V. treatment groups of CAIN457A2307.

Reporting Groups
  Description
AIN457 Subcutaneous (s.c.) During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
AIN457 I.V. During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
I.V. Period: AIN457 150 mg - AIN457 300 mg s.c. No text entered.
AIN457 300 mg - AIN457 300 mg s.c. No text entered.
AIN457 150 mg - AIN457 10 mg/kg I.V. No text entered.
AIN457 300 mg - AIN457 10 mg/kg I.V. No text entered.

Participant Flow for 5 periods

Period 1:   IV: Per Previous CAIN457A2304 Treatment
    AIN457 Subcutaneous (s.c.)   AIN457 I.V.   I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.   AIN457 300 mg - AIN457 300 mg s.c.   AIN457 150 mg - AIN457 10 mg/kg I.V.   AIN457 300 mg - AIN457 10 mg/kg I.V.
STARTED   0   0   15   6   14   8 
COMPLETED   0   0   14   6   14   6 
NOT COMPLETED   0   0   1   0   0   2 
Withdrawal by Subject                0                0                1                0                0                0 
Protocol deviation                0                0                0                0                0                1 
Lost to Follow-up                0                0                0                0                0                1 

Period 2:   IV: Per CAIN457A2307
    AIN457 Subcutaneous (s.c.)   AIN457 I.V.   I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.   AIN457 300 mg - AIN457 300 mg s.c.   AIN457 150 mg - AIN457 10 mg/kg I.V.   AIN457 300 mg - AIN457 10 mg/kg I.V.
STARTED   21   22   0   0   0   0 
COMPLETED   20   20   0   0   0   0 
NOT COMPLETED   1   2   0   0   0   0 
Withdrawal by Subject                1                0                0                0                0                0 
Protocol deviation                0                1                0                0                0                0 
Lost to Follow-up                0                1                0                0                0                0 

Period 3:   Entire: IV + Maintenance
    AIN457 Subcutaneous (s.c.)   AIN457 I.V.   I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.   AIN457 300 mg - AIN457 300 mg s.c.   AIN457 150 mg - AIN457 10 mg/kg I.V.   AIN457 300 mg - AIN457 10 mg/kg I.V.
STARTED   0   0   15   6   14   8 
COMPLETED   0   0   14   5   11   6 
NOT COMPLETED   0   0   1   1   3   2 
Withdrawal by Subject                0                0                1                1                1                0 
Adverse Event                0                0                0                0                1                0 
Protocol deviation                0                0                0                0                0                1 
Lost to Follow-up                0                0                0                0                0                1 
Lack of Efficacy                0                0                0                0                1                0 

Period 4:   Entire: IV + Maintenance
    AIN457 Subcutaneous (s.c.)   AIN457 I.V.   I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.   AIN457 300 mg - AIN457 300 mg s.c.   AIN457 150 mg - AIN457 10 mg/kg I.V.   AIN457 300 mg - AIN457 10 mg/kg I.V.
STARTED   21   22   0   0   0   0 
COMPLETED   19   17   0   0   0   0 
NOT COMPLETED   2   5   0   0   0   0 
Withdrawal by Subject                2                1                0                0                0                0 
Protocol deviation                0                1                0                0                0                0 
Lost to Follow-up                0                1                0                0                0                0 
Lack of Efficacy                0                1                0                0                0                0 
Adverse Event                0                1                0                0                0                0 

Period 5:   Follow-up
    AIN457 Subcutaneous (s.c.)   AIN457 I.V.   I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.   AIN457 300 mg - AIN457 300 mg s.c.   AIN457 150 mg - AIN457 10 mg/kg I.V.   AIN457 300 mg - AIN457 10 mg/kg I.V.
STARTED   0   0   2   1   2   0 
COMPLETED   0   0   2   1   2   0 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
  Hide 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
AIN457 Subcutaneous (s.c.) During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
AIN457 I.V. During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Total Total of all reporting groups

Baseline Measures
   AIN457 Subcutaneous (s.c.)   AIN457 I.V.   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   22   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.6  (14.53)   45.7  (12.14)   46.6  (13.24) 
Gender 
[Units: Participants]
     
Female   5   9   14 
Male   16   13   29 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI   [ Time Frame: Week 8 ]

2.  Primary:   Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response   [ Time Frame: Week 8 ]

3.  Secondary:   Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response   [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 ]

4.  Secondary:   Mean Percent Change From Baseline in PASI Scores   [ Time Frame: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 ]

5.  Secondary:   Percentage of Participants in Each IGA Mod 2011 Score Category   [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 ]

6.  Secondary:   Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1   [ Time Frame: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40 ]

7.  Secondary:   Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores   [ Time Frame: Baseline, weeks 8, 16, 24, 32 and 40 ]

8.  Secondary:   Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)   [ Time Frame: Baseline, weeks 8, 16, 24, 32 and 40 ]

9.  Secondary:   Number of Participants Who Developed Anti-secukinumab Antibodies   [ Time Frame: Baseline, weeks 12, 24 and 40 ]

10.  Secondary:   Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy   [ Time Frame: End of study ]


  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
No text entered.


  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
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01412944     History of Changes
Other Study ID Numbers: CAIN457A2307
2011-002510-36 ( EudraCT Number )
Study First Received: August 5, 2011
Results First Received: January 28, 2015
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Vietnam: Ministry of Health