Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis
1 other identifier
interventional
36
1 country
12
Brief Summary
This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2012
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 5, 2016
CompletedJanuary 5, 2016
November 1, 2015
2.9 years
February 17, 2012
December 1, 2015
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12
Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Baseline, Week 12
Secondary Outcomes (1)
Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52
Week 52
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo
secukinumab
EXPERIMENTALsecukinumab
Interventions
Eligibility Criteria
You may qualify if:
- Chronic plaque-type psoriasis diagnosed for at least 6 months
- Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
- Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy
You may not qualify if:
- Forms of psoriasis other than chronic plaque-type
- Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
- History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
- Pregnant or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Novartis Investigative Site
Birmingham, Alabama, 35205, United States
Novartis Investigative Site
Pasadena, California, 91105, United States
Novartis Investigative Site
Indianapolis, Indiana, 46256, United States
Novartis Investigative Site
St Louis, Missouri, 63117, United States
Novartis Investigative Site
East Windsor, New Jersey, 08520, United States
Novartis Investigative Site
Verona, New Jersey, 07044, United States
Novartis Investigative Site
New York, New York, 10065, United States
Novartis Investigative Site
Rochester, New York, 14623, United States
Novartis Investigative Site
High Point, North Carolina, 27262, United States
Novartis Investigative Site
Dallas, Texas, 75230, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
Novartis Investigative Site
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2012
First Posted
February 23, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 5, 2016
Results First Posted
January 5, 2016
Record last verified: 2015-11