Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/27/2019 |
| Start Date: | January 24, 2017 |
| End Date: | April 5, 2019 |
| Contact: | Novartis Pharmaceuticals |
| Email: | novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore Changes in Subcutaneous Adipose Tissue and Modulation of Skin Inflammation After 12 Weeks of Treatment With Secukinumab, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis
This study will provide a comparison of secukinumab to placebo with respect to skin
inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and
blood sample analyses.
inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and
blood sample analyses.
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed
- Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to
randomization
- Moderate to severe plaque psoriasis as defined at baseline by:
- ≥10% Body Surface Area (BSA) involvement and
- PASI total score of ≥12 and
- IGA mod 2011 score of ≥3 (based on a scale of 0-4)
Exclusion Criteria:
- Forms of diagnosed psoriasis other than chronic plaque psoriasis
- Medication-induced or medication exacerbated psoriasis
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A
or IL-17RA receptors
- Ongoing use of prohibited treatments
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
15
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
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