Psoriasis Clinical Trial
Study of Secukinumab With 2 mL Pre-filled Syringes
Summary
The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
Full Description
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe plaque-type psoriasis.
Eligibility Criteria
Inclusion Criteria:
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
Men or women of at least 18 years of age at the time of Screening.
Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
Moderate to severe psoriasis as defined at Randomization by:
PASI score of 12 or greater, and
IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and
Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
Topical treatment and/or
Phototherapy and/or
Previous systemic therapy
Exclusion Criteria:
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.
Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited.
Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
History of hypersensitivity to any of study drug constituent
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There are 51 Locations for this study
Phoenix Arizona, 85032, United States
Fountain Valley California, 92708, United States
Fremont California, 95438, United States
Miami Florida, 33155, United States
Marietta Georgia, 30060, United States
Savannah Georgia, 31406, United States
Saint Joseph Missouri, 64506, United States
Verona New Jersey, 07044, United States
Portland Oregon, 97210, United States
Portland Oregon, 97223, United States
Houston Texas, 77030, United States
San Antonio Texas, 78218, United States
Sugar Land Texas, 77479, United States
Norfolk Virginia, 23507, United States
Tacoma Washington, 98405, United States
Bruxelles , 1200, Belgium
Liege , 4000, Belgium
Edmonton Alberta, T5K 1, Canada
Surrey British Columbia, V3R 6, Canada
Berlin , 10629, Germany
Bielefeld , 33647, Germany
Essen , 45147, Germany
Heidelberg , 69120, Germany
Muenchen , 80337, Germany
Kopavogur , 201, Iceland
Daugavpils LVA, LV-54, Latvia
Jelgava LVA, LV-30, Latvia
Riga LVA, LV-10, Latvia
Ventspils LVA, LV-36, Latvia
Riga , 1012, Latvia
Riga , LV-10, Latvia
Olsztyn , 10-04, Poland
Warszawa , 02-50, Poland
Chelyabinsk , 45409, Russian Federation
Kazan , 42001, Russian Federation
Moscow , 10707, Russian Federation
Saint Petersburg , 19112, Russian Federation
Saint-Petersburg , 19402, Russian Federation
Malaga Andalucia, 29010, Spain
Sant Joan Despi Barcelona, 08970, Spain
Bilbao Bizkaia, 48013, Spain
Salamanca Castilla Y Leon, 37007, Spain
Valencia Comunidad Valenciana, 46026, Spain
Madrid , 28009, Spain
Madrid , 28046, Spain
Pontevedra , 36003, Spain
Bursa , 16059, Turkey
Izmir , 35040, Turkey
Dudley West Midlands, DY1 2, United Kingdom
Cambridge , CB7 5, United Kingdom
Dundee , DD1 9, United Kingdom
Surrey , RH1 5, United Kingdom
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