Last updated on February 2018

Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis


Brief description of study

The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).

Detailed Study Description

The overall study population (Main Study and Mechanistic Sub-study) will consist of a total of 205 male and female patients aged between 18 and 40 years inclusive.

Main Study The Main Study will be conducted in patients with new-onset moderate to severe plaque psoriasis not previously treated with any systemic treatment or phototherapy. A total of 160 patients will be randomized to Arm A1 or Arm B1 in approximately 50 sites worldwide. Since a maximum screening failure rate of 20% is expected, approximately 200 patients will be screened.

Mechanistic Sub-study Any patient who consents can participate in the Mechanistic Sub-study. Patients with new-onset plaque psoriasis will be randomized to Arm A1b, Arm A2, or Arm B1b, those with chronic plaque psoriasis will be randomized to Arm C1 and Arm C2 (15 patients each). For Arm A1b or Arm B1b, the first 15 patients will be included on a first come first serve basis.

Safety assessments :Physical examination, Vital signs, Height and body weight, Laboratory evaluations (hematology, clinical chemistry, high-sensitivity C-reactive protein), Electrocardiogram, Pregnancy, Adverse events

Data Analysis The primary efficacy variable is the proportion of patients who achieve PASI 90 at Week 52. The analysis for the primary objective will be based on the full analysis set. For the primary analysis, the following hypothesis testing will be performed: H01: psec = pnbUVB versus HA1: psec pnbUVB The primary analysis method for PASI 90 response at Week 52 will use an exact logistic regression model with treatment as an explanatory variable and baseline PASI score as covariate. The key secondary variable is the proportion of all randomized patients who achieve PASI 90 at Week 104. In order to reduce selection bias, all patients who do not achieve PASI 90 at Week 52 will also be included in the analysis at Week 104 using the PASI improvement obtained at Week 104 only.

For the key secondary analysis, the following hypothesis testing will be performed:

H02: psec = pnbUVB versus HA2: psec pnbUVB

Clinical Study Identifier: NCT03020199

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Novartis Pharmaceuticals

Novartis Investigative Site
Buenos Aires, Argentina
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Novartis Pharmaceuticals

Novartis Investigative Site
Ciudad Autonoma de Bs As, Argentina
7.76miles
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