Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-16

Study Completion Date

2016-05-02

Brief Summary

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The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Secukinumab (AIN457) 300 mg

Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.

Group Type EXPERIMENTAL

Secukinumab (AIN457)

Intervention Type DRUG

Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.

Interventions

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Secukinumab (AIN457)

Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
* Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:

* PASI score of 10 or greater and
* IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)

Exclusion Criteria

* Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
* Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L \[2.0 mg/dL\]) and hypertension at screening.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No