Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | June 22, 2016 |
End Date: | July 9, 2018 |
A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe
plaque psoriasis.
plaque psoriasis.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
107
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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