Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens (SCULPTURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01406938
First received: July 12, 2011
Last updated: April 30, 2015
Last verified: April 2015
Results First Received: February 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Moderate to Severe Plaque-type Psoriasis
Interventions: Drug: AIN457 150mg
Drug: AIN457 300mg

  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
966 patients randomized to two groups, induction secukinumab 150 mg or secukinumab 300 mg. Most randomized patients, 928/966 completed the 12-week induction period. 928 completed the induction period, a total of 843 were re-randomized to the maintenance period to either fixed interval dosing or start of relapse dosing at their respective dose level

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
AIN457150 mg- Induction Period Only(IPO) secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
AIN457 300 mg - IPO secukinumab- 2 x 150mg injections per dose
AIN457 150 mg - Fixed Interval (FI) 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
AIN457 300 mg FI 2 s.c. secukinumab 150 mg injections
AIN457 150 mg- Start of Relapse (SoR) 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
AIN457 300 mg- SoR 2 s.c. secukinumab 150 mg injections

Participant Flow for 3 periods

Period 1:   Induction Period
    AIN457150 mg- Induction Period Only(IPO)     AIN457 300 mg - IPO     AIN457 150 mg - Fixed Interval (FI)     AIN457 300 mg FI     AIN457 150 mg- Start of Relapse (SoR)     AIN457 300 mg- SoR  
STARTED     482     484     0     0     0     0  
FAS:Patients Assigned Study Treatment     482     483     0     0     0     0  
COMPLETED     464     464     0     0     0     0  
NOT COMPLETED     18     20     0     0     0     0  
Subject/guardian decision                 6                 8                 0                 0                 0                 0  
Protocol deviation                 1                 0                 0                 0                 0                 0  
Adverse Event                 8                 9                 0                 0                 0                 0  
Lack of Efficacy                 1                 0                 0                 0                 0                 0  
Lost to Follow-up                 2                 3                 0                 0                 0                 0  

Period 2:   Maintenance Period
    AIN457150 mg- Induction Period Only(IPO)     AIN457 300 mg - IPO     AIN457 150 mg - Fixed Interval (FI)     AIN457 300 mg FI     AIN457 150 mg- Start of Relapse (SoR)     AIN457 300 mg- SoR  
STARTED     0     0     203     217     206     217  
FAS: Patients Assigned Treatment Drug     0     0     203     216     206     217  
COMPLETED     0     0     186     199     181     201  
NOT COMPLETED     0     0     17     18     25     16  
Adverse Event                 0                 0                 2                 8                 4                 2  
Death                 0                 0                 0                 0                 1                 0  
Subject/guardian decision                 0                 0                 11                 7                 10                 7  
Protocol Violation                 0                 0                 2                 2                 2                 2  
Pregnancy                 0                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 0                 0                 4                 0  
Lack of Efficacy                 0                 0                 2                 1                 3                 5  

Period 3:   Follow up
    AIN457150 mg- Induction Period Only(IPO)     AIN457 300 mg - IPO     AIN457 150 mg - Fixed Interval (FI)     AIN457 300 mg FI     AIN457 150 mg- Start of Relapse (SoR)     AIN457 300 mg- SoR  
STARTED     26     23     40     39     40     35  
COMPLETED     18     18     32     36     31     32  
NOT COMPLETED     8     5     8     3     9     3  
Lack of Efficacy                 3                 2                 1                 0                 0                 0  
Patient/guardian decision                 4                 2                 4                 2                 4                 1  
Protocol Violation                 0                 0                 1                 0                 0                 0  
Physician Decision                 0                 0                 2                 0                 3                 1  
Lost to Follow-up                 1                 1                 0                 1                 2                 1  



  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.
The Full analysis set (FAS) was comprised of all patients to whom study treatment had been assigned.

Reporting Groups
  Description
AIN457150 mg- Induction Period Only(IPO) secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
AIN457 300 mg - IPO secukinumab- 2 x 150mg injections per dose
Total Total of all reporting groups

Baseline Measures
    AIN457150 mg- Induction Period Only(IPO)     AIN457 300 mg - IPO     Total  
Number of Participants  
[units: participants]
  482     484     966  
Age  
[units: Years]
Mean (Standard Deviation)
  45.3  (12.83)     46.7  (12.83)     46.0  (12.84)  
Gender  
[units: Participants]
     
Female     177     151     328  
Male     305     333     638  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52   [ Time Frame: Week 40 , week 52 ]

2.  Secondary:   Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12   [ Time Frame: Baseline, week 2, 3 , 4, 8, 12 ]

3.  Secondary:   Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52   [ Time Frame: Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52 ]

4.  Secondary:   Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)   [ Time Frame: Baseline, week 2, 4, 6, 8, 12 ]

5.  Secondary:   Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))   [ Time Frame: Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52 ]

6.  Secondary:   Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)   [ Time Frame: Baseline to week 2, 4, 8, 12 ]

7.  Secondary:   Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)   [ Time Frame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. ]

8.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)   [ Time Frame: Baseline to week 2, 4, 8, 12 ]

9.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)   [ Time Frame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. ]

10.  Secondary:   % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)   [ Time Frame: Baseline to week 2, 4, 6, 8, 12 ]

11.  Secondary:   % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).   [ Time Frame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52 ]

12.  Secondary:   Median Time to Relapse (Weeks) From Week 12.   [ Time Frame: Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. ]

13.  Secondary:   Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy   [ Time Frame: Week 12 ]

14.  Secondary:   Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy   [ Time Frame: Week 52 ]

15.  Secondary:   Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1   [ Time Frame: Week 16, 20, 24,28,32,36,40,44,48,and Week 52 ]

16.  Secondary:   Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12   [ Time Frame: week 16, 20, 24,28,32,36,40,44,48,and Week 52 ]

17.  Secondary:   Number of Participants Developing Anti-secukinumab Antibodies   [ Time Frame: Baseline, weeks 12, 24, 52 and 60 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
A limitation of this study is the lack of a placebo group; however, because the placebo response is very low in psoriasis, it is inappropriate to maintain patients on placebo for 52 weeks. .


  More Information
  Hide 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 Pharmaceutical
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01406938     History of Changes
Other Study ID Numbers: CAIN457A2304, 2011-000767-27
Study First Received: July 12, 2011
Results First Received: February 13, 2015
Last Updated: April 30, 2015
Health Authority: United States: Food and Drug Administration
Austria: Federal Ministry for Health and Women
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: Instituto Nacional de Salud
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