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
30
sites
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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