PsoriasisNCT06792487
Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)
An observational study of Psoriasis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques. Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- skin biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients affected by moderate-severe psoriasis under anti IL-23 therapy
Who may be able to join
- moderate-severe psoriasis PASI>10
- anti IL 23 biologic therapy for at least 6 months (for the group under treatment)
- during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment)
- patients able to express informed consent
Who cannot join
- patients unable to express informed consent
- patients with complete response to anti IL23, without resistant plaques or disease flare-ups
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia
Rome, Lazio, 00168
Kettu Peris, Prof, +390630155284, ketty.peris@policlinicogemelli.it
Ketty Peris, Prof
About this study
Official title: Analysis of the Immune Infiltrate in Lesional Skin During Anti-interleukin 23 (IL-23) Therapy in Patients With Moderate-severe Plaque Psoriasis
Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques.
Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development.
Read more
Although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy.
Our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-IL-23 biologic drug. The immune infiltrate of resistant or relapsed plaques during anti-IL-23 therapy will be analysed from skin biopsies.
- Conditions
- Psoriasis
- Being tested
- skin biopsy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyProcedure or surgery
punch biopsy (6 mm) of lesional psoriasis skin
| Study group | Role | What they receive |
|---|---|---|
| Sperimental | Patients affected by moderate-severe psoriasis treated with anti IL-23 therapy for at least 6 months, according to label dose. Receives: Procedure: skin biopsy | |
| No Sperimental | Patients affected by moderate-severe psoriasis that have not been already treated Receives: Procedure: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion
Through the integration of multiparametric immunofluorescence staining with RNA in situ hybridization technology, our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one lesion psoriatic lesion in patients with moderate-severe psoriasis, undergoing treatment with anti-IL-23.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
immune biomarkers of sustained and prolonged response to treatment
Identification of possible immune biomarkers of sustained and prolonged response to anti-IL-23 biological therapy that will include the expression profile of biomarkers related to tissue immune memory.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start4 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketty Peris, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792487
- Sponsor's protocol ID
- 6215
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Immune Infiltrate in Lesional Skin During Anti-interleukin 23 (IL-23) Therapy in Patients With Moderate-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06792487
- Acronym / sponsor ID
- 6215
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Jan 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.
Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques.
Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development.
Although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy.
Our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-IL-23 biologic drug. The immune infiltrate of resistant or relapsed plaques during anti-IL-23 therapy will be analysed from skin biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sperimental | – | Procedure: skin biopsyPatients affected by moderate-severe psoriasis treated with anti IL-23 therapy for at least 6 months, according to label dose. |
| No Sperimental | – | Procedure: skin biopsyPatients affected by moderate-severe psoriasis that have not been already treated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients affected by moderate-severe psoriasis under anti IL-23 therapy
Key inclusion criteria (4 listed)
- moderate-severe psoriasis PASI>10
- anti IL 23 biologic therapy for at least 6 months (for the group under treatment)
- during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment)
- patients able to express informed consent
Key exclusion criteria (2 listed)
- patients unable to express informed consent
- patients with complete response to anti IL23, without resistant plaques or disease flare-ups
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 |
|---|---|---|
| skin biopsypunch biopsy (6 mm) of lesional psoriasis skin | Procedure or surgery | No Sperimental, Sperimental |
Primary outcome
Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion
Time frame: through study completion, an average of 1 year
Through the integration of multiparametric immunofluorescence staining with RNA in situ hybridization technology, our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one lesion psoriatic lesion in patients with moderate-severe psoriasis, undergoing treatment with anti-IL-23.
1 secondary outcome
immune biomarkers of sustained and prolonged response to treatment
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
Ketty Peris, Prof principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Jan 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ketty Peris, Prof (+390630155284, ketty.peris@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.