Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2011 |
End Date: | July 2013 |
A Randomized, Double-blind, Double-dummy, Placebo Controlled, 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
This study will assess the safety and efficacy of secukinumab compared to placebo and
etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
Inclusion Criteria:
- Subjects with chronic, plaque-type psoriasis for at least 6 months
- Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater
than 3, and greater than 10% body surface area
- Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or
systemic therapies)
Exclusion Criteria:
- Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic
and guttate psoriasis)
- Drug induced psoriasis
- Use of other psoriasis treatments during the study
- Prior use of etanercept
- Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the
IL-17 receptor
- Pregnant or lactating women; women who do not agree to use contraception during the
study and for 16 weeks after stopping treatment
- Significant medical problems such as uncontrolled high blood pressure, congestive
heart failure, etc.
- History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
- Allergy to rubber or latex
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
13
sites
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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...
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