Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/5/2019 |
Start Date: | June 2011 |
End Date: | April 2013 |
A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
This study will assess the safety and efficacy of secukinumab compared to placebo in patients
that have moderate to severe, chronic, plaque-type psoriasis.
that have moderate to severe, chronic, plaque-type psoriasis.
Inclusion criteria:
- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
- Severity of psoriasis disease meeting all of the following three criteria:
- Psoriasis Area and Severity Index (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.
- Subjects not willing to limit UV light exposure during the study Other
protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
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