Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/29/2018 |
Start Date: | October 17, 2012 |
End Date: | October 27, 2016 |
A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
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.
secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with
moderate to severe chronic plaque-type psoriasis.
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.
We found this trial at
12
sites
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