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

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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

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

Trial documents
2

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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