Skip to main content
OpenTrials
Completed

NCT Number: NCT07169682

Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients With Psoriasis

Data on the antiatherogenic effect of IL23 inhibitors are sparse. This study aimed to assess the impact of one-year treatment with an IL17 or IL23 inhibitor on arterial stiffness in patients with moderate-to-severe psoriasis.

This observational cohort study included patients with moderate-to-severe psoriasis treated with either an IL17 inhibitor or an IL23 inhibitor or a conventional systemic agent/apremilast (control group) for 52 weeks. The primary outcome was the evaluation of changes in carotid-femoral pulse wave velocity (PWV) and augmentation index normalized to 75 beats/min (AIx75) after 24 and 52 weeks. Secondary outcomes were the comparison of change in PWV and AIx75 between the study groups and the assessment of psoriasis disease severity scores and in ankle-brachial index (ABI).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Arterial Occlusive Diseases Arteriosclerosis Arthritis Arthritis, Psoriatic Atherosclerosis Bone Diseases Cardiovascular Disease Cardiovascular Diseases Joint Diseases Musculoskeletal Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andreas Sygros Hospital

Athens, 17124, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate-to-severe psoriasis (Psoriasis Area Severity Index (PASI) score > 10 or Body Surface Area (BSA) >10 or Dermatology Life Quality Index (DLQI) >10)
  • Indication for treatment with an IL17 or an IL23 inhibitor based on disease characteristics and comorbidities

Exclusion criteria

  • Prior treatment with an IL17 or an IL23 inhibitor
  • Prior therapy with an TNFa-inhibitor for up to 3 months before entering the study
  • Chronic or severe acute infections, malignancy
  • Pregnancy or lactation

Treatment and study plan

interleukin 17 inhibitor

Drug

52 weeks

interleukin-23 inhibitor

Drug

52 weeks

conventional systemic agent or apremilast

Drug

52 weeks

Primary outcomes

  1. change of pulse wave velocity (PWV) from baseline to week 24 and 52

    Time frame: from enrollment to the end of treatment at week 52

    PWV can range from approximately 6.6 m/s in patients under 30 to 11.7 m/s in patients over 70 years of age; higher scores mean a worse outcome

  2. change of augmentation index normalized to 75 beats/min (AIx75) from baseline to week 24 and 52

    Time frame: from enrollment to the end of treatment at week 52

    no single universally accepted normal range for an AIx@75; lower values indicate better arterial health, with values below 20-25% often considered optimal, and values above 30% associated with increased arterial stiffness and cardiovascular risk

Secondary outcomes

  1. comparison of change in PWV between the study groups

    Time frame: From enrollment to the end of treatment at 52 weeks

  2. change in psoriasis area severity index (PASI)

    Time frame: From enrollment to the end of treatment at 52 weeks

    range 0-72; higher scores mean a worse outcome

  3. change in ankle-brachial index (ABI)

    Time frame: From enrollment to the end of treatment at 52 weeks

    range 0.9-1.4; higher scores mean worse outcome

  4. comparison of change in AIx75 between the study groups

    Time frame: from enrollment to the end of treatment at 52 weeks

  5. change in body surface area (BSA)

    Time frame: From enrollment to the end of treatment at 52 weeks

    values 0-100%, higher scores mean a worse outcome

  6. change in physician's global assessment (PGA)

    Time frame: From enrollment to the end of treatment at 52 weeks

    range 0-5; higher scores mean a worse outcome

  7. change in dermatology life quality index (DLQI)

    Time frame: From enrollment to the end of treatment at 52 weeks

    range 0-30; higher scores mean a worse outcome

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Andreas Syggros Hospital of Venereal and Dermatological Diseases

Registry information

Official study title

Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients With Psoriasis: an Observational Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.