Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Completed · Phase 3 · Has a placebo group
Conditions studied: Plaque Psoriasis
In brief
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.
Key facts
- Study ID
- NCT02826603
- Run by
- Novartis Pharmaceuticals
- People needed
- 1114
- Starts
- 2016-06-22
- Expected to finish
- 2018-07-09
- Last updated by the study team
- 2019-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must give a written, signed and dated informed consent
- Chronic plaque-type psoriasis present for at least 6 months before randomization
- Moderate to severe plaque psoriasis as defined at randomization by:
- PASI score of ≥12 and
- Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
- IGA mod 2011 ≥3 (based on a scale of 0-4)
- Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:
- Topical treatment (including topical corticosteroids) and/or
- Phototherapy and/or
- Previous systemic therapy
You may not qualify if…
- Forms of psoriasis other than plaque psoriasis
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
- Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Novartis Investigative Site — Birmingham, Alabama, United States
- Novartis Investigative Site — Birmingham, Alabama, United States
- Novartis Investigative Site — Mobile, Alabama, United States
- Novartis Investigative Site — Glendale, Arizona, United States
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Scottsdale, Arizona, United States
- Novartis Investigative Site — Scottsdale, Arizona, United States
- Novartis Investigative Site — Tucson, Arizona, United States
- Novartis Investigative Site — Fort Smith, Arkansas, United States
- Novartis Investigative Site — Hot Springs, Arkansas, United States
- Novartis Investigative Site — Rogers, Arkansas, United States
- Novartis Investigative Site — Bakersfield, California, United States
- Novartis Investigative Site — Beverly Hills, California, United States
- Novartis Investigative Site — California City, California, United States
- Novartis Investigative Site — Encinitas, California, United States
- Novartis Investigative Site — Fresno, California, United States
- Novartis Investigative Site — Fullerton, California, United States
- Novartis Investigative Site — Irvine, California, United States
- Novartis Investigative Site — Los Angeles, California, United States
- Novartis Investigative Site — Oceanside, California, United States
- Novartis Investigative Site — Sacramento, California, United States
- Novartis Investigative Site — San Diego, California, United States
- Novartis Investigative Site — San Diego, California, United States
- Novartis Investigative Site — Anniston, Alabama, United States
Full record on ClinicalTrials.gov
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