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

Use our guide to learn which trials are right for you!

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.


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
East Windsor, New Jersey 08520
2391
mi
from 98109
East Windsor, NJ
Click here to add this to my saved trials
Birmingham, Alabama 35209
2081
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
Dallas, Texas 75216
1684
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
High Point, North Carolina 27262
2290
mi
from 98109
High Point, NC
Click here to add this to my saved trials
Houston, Texas 77030
1892
mi
from 98109
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2400
mi
from 98109
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23507
2428
mi
from 98109
Norfolk, VA
Click here to add this to my saved trials
Pasadena, California 91105
957
mi
from 98109
Pasadena, CA
Click here to add this to my saved trials
Rochester, New York 14615
2159
mi
from 98109
Rochester, NY
Click here to add this to my saved trials
St. Louis, Missouri 63110
1718
mi
from 98109
St. Louis, MO
Click here to add this to my saved trials
Verona, New Jersey 07044
2387
mi
from 98109
Verona, NJ
Click here to add this to my saved trials