Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis (VIP-S)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Plaque Psoriasis

Treatments: Biological: Placebo; Drug: Secukinumab 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02690701

CAIN457AUS02

Details and patient eligibility

About

This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females at least 18 years of age with moderate to severe plaque psoriasis

Exclusion criteria

• Forms of psoriasis other than chronic plaque psoriasis
• Previous exposure to IL-17A or IL-17 receptor targeting agents.
• Other active or ongoing disease that may interfere with evaluation of psoriasis or places the patient at unacceptable risk
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 2 patient groups, including a placebo group

Secukinumab

Experimental group

Description:

Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 48 inclusive

Treatment:

Drug: Secukinumab 300 mg

Placebo then Secukinumab

Placebo Comparator group

Description:

Eligible patients received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Beginning with the Week 12 dose, participants were switched to treatment with secukinumab 300 mg and were dosed once weekly at Weeks 12, 13, 14, 15 and 16 followed by monthly dosing through Week 48 inclusive.

Treatment:

Biological: Placebo