Psoriasis Clinical Trial

Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)

Summary

The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

Severity of psoriasis disease meeting all of the following three criteria:

Psoriasis Area and Severity Index (PASI) score of 12 or greater
Investigator's Global Assessment (IGA) score of 3 or greater
Total body surface area (BSA) affected of 10% or greater
Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
Current drug-induced psoriasis.
Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
Hematological abnormalities.
History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
Pregnant or nursing (lactating) women.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

182

Study ID:

NCT01636687

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 39 Locations for this study

See Locations Near You

Novartis Investigative Site
Phoenix Arizona, 85032, United States
Novartis Investigative Site
Los Angeles California, 90045, United States
Novartis Investigative Site
Oceanside California, 92056, United States
Novartis Investigative Site
Overland Park Kansas, 66215, United States
Novartis Investigative Site
Louisville Kentucky, 40202, United States
Novartis Investigative Site
Louisville Kentucky, 40291, United States
Novartis Investigative Site
Omaha Nebraska, 68144, United States
Novartis Investigative Site
Rochester New York, 14623, United States
Novartis Investigative Site
Duncansville Pennsylvania, 16635, United States
Novartis Investigative Site
Johnston Rhode Island, 02919, United States
Novartis Investigative Site
Nashville Tennessee, 37203, United States
Novartis Investigative Site
Norfolk Virginia, 23507, United States
Novartis Investigative Site
Calgary Alberta, T3A 2, Canada
Novartis Investigative Site
Halifax Nova Scotia, B3H 1, Canada
Novartis Investigative Site
Hamilton Ontario, L8N 1, Canada
Novartis Investigative Site
Mississauga Ontario, L5H 1, Canada
Novartis Investigative Site
Montreal Quebec, H3H 1, Canada
Novartis Investigative Site
Sainte-Foy Quebec, G1V 4, Canada
Novartis Investigative Site
Tallinn , 10134, Estonia
Novartis Investigative Site
Tallinn , 13619, Estonia
Novartis Investigative Site
Nice Cedex 3 , 06202, France
Novartis Investigative Site
Poitiers , 86021, France
Novartis Investigative Site
Toulouse Cedex , 31400, France
Novartis Investigative Site
Regensburg Bavaria, 93053, Germany
Novartis Investigative Site
Augsburg , 86163, Germany
Novartis Investigative Site
Augsburg , 86179, Germany
Novartis Investigative Site
Bielefeld , 33647, Germany
Novartis Investigative Site
Bonn , 53105, Germany
Novartis Investigative Site
Dresden , 01307, Germany
Novartis Investigative Site
Erlangen , 91054, Germany
Novartis Investigative Site
Frankfurt , 60590, Germany
Novartis Investigative Site
Gera , 07548, Germany
Novartis Investigative Site
Hamburg , 22143, Germany
Novartis Investigative Site
Hamburg , 22391, Germany
Novartis Investigative Site
Heidelberg , 69115, Germany
Novartis Investigative Site
Muenster , 48149, Germany
Novartis Investigative Site
Osnabruck , 49074, Germany
Novartis Investigative Site
Selters , 56242, Germany
Novartis Investigative Site
Tuebingen , 72076, Germany

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

182

Study ID:

NCT01636687

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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