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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04488185
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 2, 2020
Status verified
Mar 2023
Primary completion
Mar 24, 2021
Completion
Mar 24, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab 300mg
    Randomized in a 2:1 ratio to secukinumab or placebo
  • Placebo Comparator: Placebo
    Randomized in a 2:1 ratio to secukinumab or placebo

Primary Outcome Measure

Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) ultrasound enthesitis score [ Time Frame: Baseline and Week 16 ]

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