Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (ERASURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01365455
First received: June 1, 2011
Last updated: May 7, 2015
Last verified: May 2015
Results First Received: February 16, 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: secukinumab 150 mg
Drug: placebo to secukinumab 150 mg

  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
Not all patients that completed Maintenance Period continued in the follow-up Period. Many patients from Maintence rolled into CAIN457A2302E1 study

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 150 mg AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 300 mg AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Placebo placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
AIN457 150mg From Placebo Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
AIN457 300mg From Placebo Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.

Participant Flow for 3 periods

Period 1:   Induction Period
    AIN457 150 mg     AIN457 300 mg     Placebo     AIN457 150mg From Placebo     AIN457 300mg From Placebo  
STARTED     245     245     248     0     0  
COMPLETED     230     238     232     0     0  
NOT COMPLETED     15     7     16     0     0  
Adverse Event                 5                 3                 4                 0                 0  
Lack of Efficacy                 1                 1                 0                 0                 0  
Pregnancy                 0                 1                 0                 0                 0  
Protocol deviation                 0                 1                 1                 0                 0  
Subject/guardian decision                 9                 1                 8                 0                 0  
Lost to Follow-up                 0                 0                 3                 0                 0  

Period 2:   Maintenance Period
    AIN457 150 mg     AIN457 300 mg     Placebo     AIN457 150mg From Placebo     AIN457 300mg From Placebo  
STARTED     230     238     18     109     105  
COMPLETED     201     215     15     100     92  
NOT COMPLETED     29     23     3     9     13  
Adverse Event                 12                 5                 1                 2                 4  
Lack of Efficacy                 10                 2                 0                 2                 2  
Lost to Follow-up                 2                 4                 0                 0                 3  
Non-compliance with study treatment                 0                 0                 0                 1                 0  
Physician Decision                 0                 1                 0                 0                 1  
Pregnancy                 0                 4                 0                 0                 2  
Protocol deviation                 1                 1                 0                 0                 0  
Subject/guardian decision                 4                 6                 2                 4                 1  

Period 3:   Follow-up Period
    AIN457 150 mg     AIN457 300 mg     Placebo     AIN457 150mg From Placebo     AIN457 300mg From Placebo  
STARTED     58     47     18     0     0  
COMPLETED     58     47     18     0     0  
NOT COMPLETED     0     0     0     0     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.
No text entered.

Reporting Groups
  Description
AIN457 150 mg AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
AIN457 300 mg AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
Placebo placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Total Total of all reporting groups

Baseline Measures
    AIN457 150 mg     AIN457 300 mg     Placebo     Total  
Number of Participants  
[units: participants]
  245     245     248     738  
Age  
[units: years]
Mean (Standard Deviation)
  44.9  (13.33)     44.9  (13.46)     45.4  (12.63)     45.1  (13.13)  
Gender  
[units: participants]
       
Female     77     76     76     229  
Male     168     169     172     509  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks   [ Time Frame: 12 weeks ]

2.  Primary:   Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1   [ Time Frame: 12 weeks ]

3.  Secondary:   Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12   [ Time Frame: 12 weeks ]

4.  Secondary:   Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12   [ Time Frame: 12 and 52 weeks ]

5.  Secondary:   Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12   [ Time Frame: 12 and 52 weeks ]

6.  Secondary:   Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo   [ Time Frame: Week 12 ]

7.  Secondary:   Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period   [ Time Frame: Week 1,2,3,4,8,12, ]

8.  Secondary:   Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52   [ Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52 ]

9.  Secondary:   Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period   [ Time Frame: Baseline, Week 1,2,3,4,8,12, ]

10.  Secondary:   Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52   [ Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52 ]

11.  Secondary:   Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period   [ Time Frame: Baseline, Week 1,2,3,4,8,12, ]

12.  Secondary:   Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52   [ Time Frame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52 ]

13.  Secondary:   Time to PASI 75 Response up to 12 Weeks   [ Time Frame: Week 12 ]

14.  Secondary:   Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period   [ Time Frame: Baseline, Week 4,8, 12 ]

15.  Secondary:   Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period   [ Time Frame: Week 12, 24, 36, 52 ]

16.  Secondary:   Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period   [ Time Frame: Baseline, Week 4, 8 & 12 ]

17.  Secondary:   Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period   [ Time Frame: Week 12,24, 36 & 52 ]

18.  Secondary:   Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period   [ Time Frame: Week 4, 8, 12 ]

19.  Secondary:   Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period   [ Time Frame: Week 12,24,36, & 52 ]

20.  Secondary:   Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy   [ Time Frame: Week 12 ]

21.  Secondary:   Number of Participants Who Developed Anti-secukinumab Antibodies   [ Time Frame: Week 12 ]


  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 by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01365455     History of Changes
Other Study ID Numbers: CAIN457A2302, 2010-023512-13
Study First Received: June 1, 2011
Results First Received: February 16, 2015
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Estonia: The State Agency of Medicine
Iceland: Icelandic Medicines Control Agency
Israel: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Panama: Ministry of Health
Peru: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Taiwan: Department of Health