NCT04488185

An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound

An Exploratory, Randomized, Double-blind, Parallel-group, Multicenter Study to Compare Secukinumab 300 mg With Placebo After 16 Weeks of Treatment in Adults With Moderate to Severe Plaque Psoriasis and Subclinical Enthesitis Measured by Musculoskeletal Ultrasound

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of subclinical enthesitis in psoriasis patients. This study will be the first randomized trial of a biologic therapy versus placebo in participants with plaque psoriasis and subclinical psoriatic arthritis, using musculoskeletal ultrasound.

Detailed description

The primary objective of this study is to estimate the difference in effect between secukinumab 300 mg s.c. and placebo, based on change from baseline to Week 16 in the OMERACT ultrasound enthesitis score.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab 300 mg	Secukinumab 300 mg administered s.c. (2 single-use prefilled syringes of 150 mg/mL), on Days 1, 8, 15, 22, 29, 57, 85.
OTHER	Placebo	Placebo administered s.c. (2 single-use prefilled 1 mL syringes) on Days 1, 8, 15, 22, 29, 57, 85.

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-03-24
• Completion: 2021-03-24
• First posted: 2020-07-27
• Last updated: 2023-03-31

Regulatory

• FDA-regulated drug study