Back to resultsEfficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
Primary Purpose
Psoriasis
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intervention A
Intervention B
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Chronic plaque-type psoriasis, moderate to severe
- Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy
Exclusion Criteria:
- Forms of psoriasis other than chronic plaque-type
- Ongoing use of treatments not allowed for psoriasis
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Experimental
Arm Label
Dosing Regimen 1
Active Comparator
Placebo
Dosing Regimen 2
Arm Description
Subcutaneous injection
Subcutaneous injection
Subcutaneous injection
Subcutaneous injection
Outcomes
Primary Outcome Measures
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Secondary Outcome Measures
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Vital signs, laboratory values, electrocardiograms (ECG), adverse events
Patient reported outcome questionnaires
Full Information
NCT ID
NCT01900782
First Posted
July 12, 2013
Last Updated
August 14, 2013
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01900782
Brief Title
Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
Official Title
A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dosing Regimen 1
Arm Type
Experimental
Arm Description
Subcutaneous injection
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injection
Arm Title
Dosing Regimen 2
Arm Type
Experimental
Arm Description
Subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Intervention A
Intervention Description
Prefilled syringe.
Intervention Type
Biological
Intervention Name(s)
Intervention B
Intervention Description
Prefilled syringe.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Prefilled syringe to match experimental drug and active comparator.
Primary Outcome Measure Information:
Title
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Time Frame
Week 52
Title
Vital signs, laboratory values, electrocardiograms (ECG), adverse events
Time Frame
Week 12 and 52
Title
Patient reported outcome questionnaires
Time Frame
Week 12 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic plaque-type psoriasis, moderate to severe
Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy
Exclusion Criteria:
Forms of psoriasis other than chronic plaque-type
Ongoing use of treatments not allowed for psoriasis
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
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