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 — STEPin  

Plaque Psoriasis Clinical Trial

Official title: A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

The design consists of the Main Study and a Mechanistic Sub study:

1. The Main Study will be multicenter, randomized, 2-treatment-arm (secukinumab and nb-UVB), parallel-group and open-label. It will include 3 clinical periods (Screening period, Treatment period, and Follow-up period) involving all patients in Arms A1 (A1a and A1b) and B1 (B1a and B1b).

2. The Mechanistic Sub-study will be open-label and comprise 5 treatment arms (A1b, A2, B1b, C1, and C2). It will include 2 periods (Screening period and Treatment period) for patients in Arms C1, C2 and A2. Patients from Arms A1b and B1b will undergo the 3 clinical periods of the Main Study.

The overall study population (Main Study and Mechanistic Sub-study) will consist of a total of 196 male and female patients aged between 18 and 50 years inclusive.

1. 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 75 sites worldwide. Since a maximum screening failure rate of 20% is expected, approximately 245 patients will be screened.

2. 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 (12 patients each).

For Arm A1b or Arm B1b, the first 12 patients will be included on a first come first serve basis. ;

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

• NCT number: NCT03020199
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 4
• Start date: March 27, 2017
• Completion date: June 16, 2023