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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02547714
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab (AIN457) — DRUG
    Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.

Study Details

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.

Key Dates

Start date
Jun 16, 2015
Status verified
Aug 2017
Primary completion
May 2, 2016
Completion
May 2, 2016

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75) [ Time Frame: Week 16 ]

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