Clinical Trial Review
October 2012 | Volume 11 | Issue 10 | Features | 1251 | Copyright © October 2012
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
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
Sponsored by Novartis Pharmaceuticals, 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 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.
The primary outcome measure is Proportion of patients achieving
skin histology response after secukinumab treatment.
Inclusion criteria includes those with 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%, and chronic
plaque-type psoriasis considered inadequately controlled by topical
treatment and/or phototherapy and/or previous systemic therapy.
Those with forms of psoriasis other than chronic plaque-type
or evidence of skin conditions at the time of the screening visit
(eg, eczema) that would interfere with evaluations of the effect
of the investigational product on psoriasis will be excluded,
as will those with a 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 (eg, AIDS, RA, organ rejection, etc.) at the
screening visit, or pregnant or nursing (lactating) women.
A 12-Week Multicenter, Randomized, Double-Blind,
Placebo-Controlled Study Comparing the Efficacy
and Safety of LY2439821 to Etanercept and Placebo
in Patients With Moderate to Severe Plaque
Psoriasis With a Long-Term Extension Period
Sponsored by Eli Lilly and Company, this study will assess the
safety and efficacy of ixekizumab (LY2439821) compared to
etanercept and placebo in participants with moderate to severe
chronic plaque psoriasis.
The primary outcome measure is the efficacy of ixekizumab in
participants with moderate to severe chronic plaque psoriasis.
Participants who present with chronic plaque psoriasis based
on a confirmed diagnosis of chronic psoriasis for at least 6
months prior to randomization, with at least 10% Body Surface
Area (BSA) of Psoriasis at screening and at randomization,
and/or sPGA score of at least 3 and PASI score of at least 12 at
screening and at randomization are eligible, as are candidates
for phototherapy and/or systemic therapy. Men must agree to
use a reliable method of birth control or remain abstinent during
the study. Women must agree to use reliable birth control
or remain abstinent during the study and for at least 12 weeks
after stopping treatment.
Those with pustular, erythrodermic, and/or guttate forms of
psoriasis, history of drug-induced psoriasis, and/or prior use of
etanercept will be excluded. Those with a clinically significant
flare of psoriasis during the 12 weeks prior to randomization
and/or concurrent or recent use of any biologic agent will be
excluded, as will individuals who have received non-biologic
systemic psoriasis therapy or phototherapy (including psoralens
and ultraviolet A [PUVA], ultraviolet B [UVB]) within the
previous 4 weeks, or had topical psoriasis treatment within the
previous 2 weeks prior to randomization. Participants who cannot
avoid excessive sun exposure or use of tanning booths for
at least 4 weeks prior to randomization and during the study,
who have participated in any study with interleukin 17 (IL-17)
antagonists, including ixekizumab, have a serious disorder or
illness other than plaque psoriasis and/or a serious infection
within the last 3 months cannot participate. Breastfeeding or
nursing (lactating) women are also ineligible.
Phase I/II Study of Metastatic Melanoma Using
Lymphodepleting Conditioning Followed by Infusion
of Tumor Infiltrating Lymphocytes Genetically
Engineered to Express IL-12
Sponsored by the National Cancer Institute (NCI), this study aims
to determine the safety and effectiveness of cell therapy using IL-
12 modified tumor white blood cells to treat metastatic melanoma.
The primary outcome measure is to evaluate the safety of the
administration of IL-12 engineered TIL in patients receiving a