Clinical Trial Review
October 2012 | Volume 11 | Issue 10 | Feature | 1251 | Copyright © 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.
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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