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

NCT ID: NCT07169682

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Psoriasis Cardiovascular Disease Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

IL17 inhibitor

interleukin 17 inhibitor

Intervention Type DRUG

52 weeks

Group 2

IL23 inhibitor

interleukin-23 inhibitor

Intervention Type DRUG

52 weeks

Group 3

conventional systemic agent or apremilast

conventional systemic agent or apremilast

Intervention Type DRUG

52 weeks

Interventions

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interleukin 17 inhibitor

52 weeks

Intervention Type DRUG

interleukin-23 inhibitor

52 weeks

Intervention Type DRUG

conventional systemic agent or apremilast

52 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andreas Syggros Hospital of Venereal and Dermatological Diseases

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Aikaterini Tsiogka

dermatologist, clinical research associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Andreas Sygros Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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Tsiogka A, Soulaidopoulos S, Gregoriou S, Rompoti N, Panagakis P, Papoutsaki M, Kostakis P, Kontochristopoulos G, Tsioufis K, Vlachopoulos C, Stratigos A, Rigopoulos D. Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients with Psoriasis: An Observational Study. Dermatol Ther (Heidelb). 2025 Oct 8. doi: 10.1007/s13555-025-01549-1. Online ahead of print.

Reference Type DERIVED
PMID: 41060491 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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3610/20-05-2021

Identifier Type: -

Identifier Source: org_study_id

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