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

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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.


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
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Los Angeles, California 90095
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Albuquerque, New Mexico 87108
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230 Park Avenue, 21st Floor
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