Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
Completed · Phase 3 · Has a placebo group
Conditions studied: Plaque-type Psoriasis
In brief
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.
Key facts
- Study ID
- NCT01636687
- Run by
- Novartis Pharmaceuticals
- People needed
- 182
- Starts
- 2012-10-17
- Expected to finish
- 2016-10-27
- Last updated by the study team
- 2018-09-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Los Angeles, California, United States
- Novartis Investigative Site — Oceanside, California, United States
- Novartis Investigative Site — Overland Park, Kansas, United States
- Novartis Investigative Site — Louisville, Kentucky, United States
- Novartis Investigative Site — Louisville, Kentucky, United States
- Novartis Investigative Site — Omaha, Nebraska, United States
- Novartis Investigative Site — Rochester, New York, United States
- Novartis Investigative Site — Duncansville, Pennsylvania, United States
- Novartis Investigative Site — Johnston, Rhode Island, United States
- Novartis Investigative Site — Nashville, Tennessee, United States
- Novartis Investigative Site — Norfolk, Virginia, United States
- Novartis Investigative Site — Calgary, Alberta, Canada
- Novartis Investigative Site — Halifax, Nova Scotia, Canada
- Novartis Investigative Site — Hamilton, Ontario, Canada
- Novartis Investigative Site — Mississauga, Ontario, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Sainte-Foy, Quebec, Canada
- Novartis Investigative Site — Tallinn, Estonia
- Novartis Investigative Site — Tallinn, Estonia
- Novartis Investigative Site — Nice, France
- Novartis Investigative Site — Poitiers, France
- Novartis Investigative Site — Toulouse, France
- Novartis Investigative Site — Regensburg, Bavaria, Germany
- Novartis Investigative Site — Augsburg, Germany
Full record on ClinicalTrials.gov
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