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.

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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.

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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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

214

Study ID:

NCT02748863

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 51 Locations for this study

See Locations Near You

Novartis Investigative Site
Phoenix Arizona, 85032, United States
Novartis Investigative Site
Fountain Valley California, 92708, United States
Novartis Investigative Site
Fremont California, 95438, United States
Novartis Investigative Site
Miami Florida, 33155, United States
Novartis Investigative Site
Marietta Georgia, 30060, United States
Novartis Investigative Site
Savannah Georgia, 31406, United States
Novartis Investigative Site
Saint Joseph Missouri, 64506, United States
Novartis Investigative Site
Verona New Jersey, 07044, United States
Novartis Investigative Site
Portland Oregon, 97210, United States
Novartis Investigative Site
Portland Oregon, 97223, United States
Novartis Investigative Site
Houston Texas, 77030, United States
Novartis Investigative Site
San Antonio Texas, 78218, United States
Novartis Investigative Site
Sugar Land Texas, 77479, United States
Novartis Investigative Site
Norfolk Virginia, 23507, United States
Novartis Investigative Site
Tacoma Washington, 98405, United States
Novartis Investigative Site
Bruxelles , 1200, Belgium
Novartis Investigative Site
Liege , 4000, Belgium
Novartis Investigative Site
Edmonton Alberta, T5K 1, Canada
Novartis Investigative Site
Surrey British Columbia, V3R 6, Canada
Novartis Investigative Site
Berlin , 10629, Germany
Novartis Investigative Site
Bielefeld , 33647, Germany
Novartis Investigative Site
Essen , 45147, Germany
Novartis Investigative Site
Heidelberg , 69120, Germany
Novartis Investigative Site
Muenchen , 80337, Germany
Novartis Investigative Site
Kopavogur , 201, Iceland
Novartis Investigative Site
Daugavpils LVA, LV-54, Latvia
Novartis Investigative Site
Jelgava LVA, LV-30, Latvia
Novartis Investigative Site
Riga LVA, LV-10, Latvia
Novartis Investigative Site
Ventspils LVA, LV-36, Latvia
Novartis Investigative Site
Riga , 1012, Latvia
Novartis Investigative Site
Riga , LV-10, Latvia
Novartis Investigative Site
Olsztyn , 10-04, Poland
Novartis Investigative Site
Warszawa , 02-50, Poland
Novartis Investigative Site
Chelyabinsk , 45409, Russian Federation
Novartis Investigative Site
Kazan , 42001, Russian Federation
Novartis Investigative Site
Moscow , 10707, Russian Federation
Novartis Investigative Site
Saint Petersburg , 19112, Russian Federation
Novartis Investigative Site
Saint-Petersburg , 19402, Russian Federation
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Sant Joan Despi Barcelona, 08970, Spain
Novartis Investigative Site
Bilbao Bizkaia, 48013, Spain
Novartis Investigative Site
Salamanca Castilla Y Leon, 37007, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46026, Spain
Novartis Investigative Site
Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28046, Spain
Novartis Investigative Site
Pontevedra , 36003, Spain
Novartis Investigative Site
Bursa , 16059, Turkey
Novartis Investigative Site
Izmir , 35040, Turkey
Novartis Investigative Site
Dudley West Midlands, DY1 2, United Kingdom
Novartis Investigative Site
Cambridge , CB7 5, United Kingdom
Novartis Investigative Site
Dundee , DD1 9, United Kingdom
Novartis Investigative Site
Surrey , RH1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

214

Study ID:

NCT02748863

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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