Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/23/2018
Start Date:June 19, 2013
End Date:November 2, 2016

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

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Palmoplantar Psoriasis

Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on
palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of
secukinumab.


Inclusion Criteria:

- Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months
prior to randomization and significant involvement of the palms and soles at baseline,
defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a
5-point scale, as well as at least one skin plaque at baseline which is not in the
palmoplantar area

- Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical
treatment (including super potent topical corticosteroids) and/or phototherapy and/or
previous systemic therapy

Exclusion Criteria:

- Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis,
palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate
psoriasis)

- Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers,
calcium channel inhibitors or lithium)

- Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS),
UV therapy). Washout periods do apply.

- Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting
IL-17 or the IL-17 receptor

- Use of any investigational drugs within 4 weeks prior to study treatment initiation or
within a period of 5 half-lives of the investigational treatment, whichever is longer

- Active ongoing inflammatory diseases other than psoriasis that might confound the
evaluation of the benefit of secukinumab therapy

- History of hypersensitivity to constituents of the study treatment
We found this trial at
9
sites
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Goodlettsville, Tennessee 37072
?
mi
from
Goodlettsville, TN
Click here to add this to my saved trials
High Point, North Carolina 27262
?
mi
from
High Point, NC
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Sydney, New South Wales
?
mi
from
Sydney,
Click here to add this to my saved trials
Verona, New Jersey 07044
?
mi
from
Verona, NJ
Click here to add this to my saved trials