Last updated on August 2020

Efficacy and Safety of 2 Secukinumab Regimens in 90 kg or Higher Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Brief description of study

Demonstrate superiority of secukinumab high dose over standard dose in heavy body weight subjects with moderate to severe plaque psoriasis.

Detailed Study Description

A 52-week multicenter, randomized, double-blind, parallel-group trial in approximately 330 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.

The study consists of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).

Subjects will be randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.

In addition, subjects from the 300 mg every 4 weeks group who do not achieve PASI 90 response at Week 16 will be randomized using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.

Clinical Study Identifier: NCT03504852

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.