PsoriasisNCT07169682
Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients With Psoriasis
An observational study of Psoriasis and Cardiovascular Disease, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Cardiovascular Disease, Atherosclerosis
- What is being tested?
- interleukin 17 inhibitor, interleukin-23 inhibitor and conventional systemic agent or apremilast
- How many people
- 66 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2021to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with plaque psoriasis with or without psoriatic arthritis, who were monitored in the outpatient department for psoriasis of "Andreas Syngros" hospital for skin diseases and were planed to start treatment with an IL17 inhibitor or an IL23 inhibitor on a conventional systemic agent/apremilast
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients With Psoriasis: an Observational Study
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).
- Conditions
- Psoriasis, Cardiovascular Disease, Atherosclerosis
- Being tested
- interleukin 17 inhibitor, interleukin-23 inhibitor, conventional systemic agent or apremilast
- Keywords
- psoriasis, atherosclerosis, cardiovascular disease, psoriatic arthritis
- Medical subject headings
- Psoriasis, Cardiovascular Diseases, Atherosclerosis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin 17 inhibitorDrug
52 weeks
interleukin-23 inhibitorDrug
52 weeks
conventional systemic agent or apremilastDrug
52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | IL17 inhibitor Receives: Drug: interleukin 17 inhibitor | |
| Group 2 | IL23 inhibitor Receives: Drug: interleukin-23 inhibitor | |
| Group 3 | conventional systemic agent or apremilast Receives: Drug: conventional systemic agent or apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pulse wave velocity (PWV) from baseline to week 24 and 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
Measured: from enrollment to the end of treatment at week 52
change of augmentation index normalized to 75 beats/min (AIx75) from baseline to week 24 and 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
Measured: from enrollment to the end of treatment at week 52
Secondary outcomes (7)
comparison of change in PWV between the study groups
Measured: From enrollment to the end of treatment at 52 weeks
change in psoriasis area severity index (PASI)
range 0-72; higher scores mean a worse outcome
Measured: From enrollment to the end of treatment at 52 weeks
change in ankle-brachial index (ABI)
range 0.9-1.4; higher scores mean worse outcome
Measured: From enrollment to the end of treatment at 52 weeks
comparison of change in AIx75 between the study groups
Measured: from enrollment to the end of treatment at 52 weeks
change in body surface area (BSA)
values 0-100%, higher scores mean a worse outcome
Measured: From enrollment to the end of treatment at 52 weeks
change in physician's global assessment (PGA)
range 0-5; higher scores mean a worse outcome
Measured: From enrollment to the end of treatment at 52 weeks
change in dermatology life quality index (DLQI)
range 0-30; higher scores mean a worse outcome
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Sep 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Andreas Syggros Hospital of Venereal and Dermatological Diseases
- Responsible party
- Principal investigator, Aikaterini Tsiogka, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169682
- Sponsor's protocol ID
- 3610/20-05-2021
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Dec;15(12):3777-3792. doi: 10.1007/s13555-025-01549-1. Epub 2025 Oct 8.
PubMed 41060491
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients With Psoriasis: an Observational Study
- ClinicalTrials.gov ID
- NCT07169682
- Acronym / sponsor ID
- 3610/20-05-2021
- Conditions
- Psoriasis, Cardiovascular Disease, Atherosclerosis
- Keywords
- psoriasis, atherosclerosis, cardiovascular disease, psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Andreas Syggros Hospital of Venereal and Dermatological Diseases
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: interleukin 17 inhibitorIL17 inhibitor |
| Group 2 | – | Drug: interleukin-23 inhibitorIL23 inhibitor |
| Group 3 | – | Drug: conventional systemic agent or apremilastconventional systemic agent or apremilast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with plaque psoriasis with or without psoriatic arthritis, who were monitored in the outpatient department for psoriasis of "Andreas Syngros" hospital for skin diseases and were planed to start treatment with an IL17 inhibitor or an IL23 inhibitor on a conventional systemic agent/apremilast
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interleukin 17 inhibitor52 weeks | Drug | Group 1 |
| interleukin-23 inhibitor52 weeks | Drug | Group 2 |
| conventional systemic agent or apremilast52 weeks | Drug | Group 3 |
Primary outcome
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
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
7 secondary outcomes
comparison of change in PWV between the study groups
Time frame: From enrollment to the end of treatment at 52 weeks
change in psoriasis area severity index (PASI)
Time frame: From enrollment to the end of treatment at 52 weeks
change in ankle-brachial index (ABI)
Time frame: From enrollment to the end of treatment at 52 weeks
comparison of change in AIx75 between the study groups
Time frame: from enrollment to the end of treatment at 52 weeks
change in body surface area (BSA)
Time frame: From enrollment to the end of treatment at 52 weeks
change in physician's global assessment (PGA)
Time frame: From enrollment to the end of treatment at 52 weeks
change in dermatology life quality index (DLQI)
Time frame: From enrollment to the end of treatment at 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 41060491Tsiogka 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 Dec;15(12):3777-3792. doi: 10.1007/s13555-025-01549-1. Epub 2025 Oct 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Cardiovascular Disease, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.