Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | December 2014 |
Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis
This study is designed to evaluate the proportion of patients achieving reversal of chronic
plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered
subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive
multiple doses of secukinumab up to week 52 to study long term effects of secukinumab.
Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to
better understand, why secukinumab may be effective in psoriasis patients.
plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered
subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive
multiple doses of secukinumab up to week 52 to study long term effects of secukinumab.
Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to
better understand, why secukinumab may be effective in psoriasis patients.
Inclusion criteria:
- Chronic plaque-type psoriasis diagnosed for at least 6 months
- Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA
(body surface area) affected by plaque-type psoriasis of ≥10%
- Chronic plaque-type psoriasis considered inadequately controlled by: topical
treatment and/or; phototherapy and/or previous systemic therapy
Exclusion criteria:
- Forms of psoriasis other than chronic plaque-type
- Evidence of skin conditions at the time of the screening visit (e.g., eczema) that
would interfere with evaluations of the effect of the investigational product on
psoriasis
- History or evidence of active tuberculosis or evidence of latent tuberculosis (or
other infections like Hepatitis-C/B), malignancy; active or known use of other
immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening
visit
- Pregnant or nursing (lactating) women
We found this trial at
12
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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