Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/15/2017
Start Date:September 2014
End Date:December 2015

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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 Weeks of Treatment, Compared to Placebo, and to Assess Safety and Tolerability up to 24 Weeks in Adult Subjects With Moderate to Severe Scalp Psoriasis

This study will assess the efficacy and safety of secukinumab compared to placebo in adult
patients who have moderate to severe scalp psoriasis that is poorly controlled by current
psoriasis treatments.


Inclusion Criteria:

- Chronic scalp psoriasis for at least the previous six months

- Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher
of scalp surface area affected

- Must be candidates for systemic therapy, which means having scalp psoriasis
inadequately controlled by topical treatments (corticosteroids), and/or phototherapy,
and/or previous systemic therapy.

Exclusion Criteria:

- Forms of psoriasis other than chronic plaque

- Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers,
calcium channel inhibitors)

- Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV
therapy)

- Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting
IL17A or IL-17RA receptors

- Use of other investigational drugs within 30 days prior to study entry, or within a
period of 5 half-lives of the investigational treatment, whichever is longer

- Active, ongoing inflammatory diseases other than psoriasis that might confound the
evaluation of the benefit of secukinumab

- Active system infections (with the exception of the common cold) during the two weeks
prior to starting study treatment

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
16
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Andover, Massachusetts 01810
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Arlington, Texas 76012
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Aurora, Colorado 80010
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Boston, Massachusetts 02118
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East Windsor, New Jersey 08520
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Gahanna, Ohio 43230
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Hershey, Pennsylvania 17033
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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New York, NY
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Rockville, Maryland 20852
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Sacramento, California 95825
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Troy, Michigan 48098
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Trumbull, Connecticut 06611
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West Jordan, Utah 84088
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Winston-Salem, North Carolina 27157
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