Status:
COMPLETED
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Moderate to Severe Plaque-type Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psorias...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
- Severity of disease meeting all of the following three criteria:
- PASI score of 12 or greater,
- Investigator's Global Assessment (IGA) score of 3 or greater
- Total body surface area (BSA) affected of 10% or greater.
- Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
- Exclusion criteria:
- Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
- Current drug-induced psoriasis.
- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
- Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
- Hematological abnormalities.
- History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
- History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
967 Patients enrolled
Trial Details
Trial ID
NCT01406938
Start Date
August 1 2011
End Date
May 1 2013
Last Update
May 19 2015
Active Locations (131)
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1
Novartis Investigative Site
Fresno, California, United States, 93710
2
Novartis Investigative Site
Pasadena, California, United States, 91105
3
Novartis Investigative Site
Sacramento, California, United States, 95817
4
Novartis Investigative Site
San Francisco, California, United States, 94118