PsoriasisNCT07448402
Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease
An observational study of Psoriasis and Psoriasis Arthritis, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
Trial summary
The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Psoriasis, Psoriasis Arthritis, Psoriasis (PsO)
- What is being tested?
- Guselkumab (GUS) and Risankizumab (RISA)
- How many people
- 50 participants
- Where
- 1 siteCosta Rica
- Study dates
- May 2026to May 2031
- How long will I take part?
- 5 Years
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of adolescents and adults (≥12 years) with psoriatic disease receiving IL-23 inhibitors within the Costa Rican public health system. This real-world national cohort includes patients with both cutaneous psoriasis and psoriatic arthritis across participating centers. The registry aims to capture the full treated population over time to describe clinical evolution, treatment response, safety, persistence, and associated comorbidities in the national context.
Who may be able to join
- Confirmed diagnosis of psoriatic disease, including psoriasis (any clinical variant) and/or psoriatic arthritis based on rheumatologic criteria.
- Receiving IL-23 inhibitor therapy (guselkumab or risankizumab).
- Treated within participating Costa Rican public health centers.
- Availability of sufficient clinical records to complete registry data (history, follow-up, labs).
- Age ≥12 years, any sex.
Who cannot join
- None specified (all patients meeting inclusion criteria are eligible).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Costa Rica1 site
Caja Costarricense del Seguro Social
San José, Provincia de San José, 40901
Daniel E Barquero-Orias, Dermatologist, +506 83411026, debarque@ccss.sa.cr
About this study
Official title: National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System
The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:
- Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
- What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
- Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.
Read the detailed description
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic inflammatory condition with substantial clinical and functional impact. Although IL-23 inhibitors such as guselkumab and risankizumab have shown high efficacy and favorable safety in international trials, real-world evidence in Latin America-and particularly Costa Rica-is limited. Differences in comorbidities, population genetics, access to therapy, and health-system factors may influence treatment response and safety outcomes.
This national observational registry is designed to generate standardized real-world data on patients with psoriatic disease treated with IL-23 inhibitors within the Costa Rican public health system. The registry will collect demographic and clinical characteristics, dermatologic and rheumatologic disease activity scores, treatment patterns, persistence, and adverse events over time. The resulting evidence will support clinical decision-making, optimize therapeutic strategies, and inform national health policy regarding biologic therapies for psoriatic disease.
- Conditions
- Psoriasis, Psoriasis Arthritis, Psoriasis (PsO)
- Being tested
- Guselkumab (GUS), Risankizumab (RISA)
- Keywords
- Psoriasis, IL-23, Registry, Costa Rica
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab (GUS)Biological
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immune responses. This mechanism distinguishes them from IL-12/23 inhibitors (p40 blockade) and IL-17 inhibitors (downstream cytokine inhibition).
IL-23 inhibitors also differ in dosing interval (every 8-12 weeks) and safety profile, with lower candidiasis risk than IL-17 blockade and different infection patterns than TNF-α inhibitors. This national registry specifically evaluates real-world effectiveness, safety, and treatment persistence of IL-23 inhibitors.
Risankizumab (RISA)Biological
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immune responses. This mechanism distinguishes them from IL-12/23 inhibitors (p40 blockade) and IL-17 inhibitors (downstream cytokine inhibition).
IL-23 inhibitors also differ in dosing interval (every 8-12 weeks) and safety profile, with lower candidiasis risk than IL-17 blockade and different infection patterns than TNF-α inhibitors. This national registry specifically evaluates real-world effectiveness, safety, and treatment persistence of IL-23 inhibitors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease
Proportion of patients achieving:
- Psoriasis Area and Severity Index 75, 90, and 100 response
- Dermatology Life Quality Index score of 0 or 1
- Disease Activity in Psoriatic Arthritis.
Measured: 5 years
Safety of Interleukin-23 Inhibitors
Incidence rate of adverse events and serious adverse events, including:
- Serious infections
- Hospitalizations
- New malignancy
- Thrombotic events
- Injection-site reactions
- Treatment discontinuation due to adverse events
Measured: 5 years
Secondary outcomes (5)
Change in Psoriasis Severity
Absolute and relative change in:
- Psoriasis Area and Severity Index
- Body Surface Area affected
- Dermatology Life Quality Index score
Measured: 5 years
Articular Disease Activity
Change from baseline in articular disease activity assessed by Tender Joint Count, Swollen Joint Count, and Disease Activity in Psoriatic Arthritis Score. Resolution of dactylitis and improvement in enthesitis will also be recorded when present.
Measured: 5 years
Treatment Persistence
Time in months from initiation of guselkumab or risankizumab to treatment discontinuation for any reason. Persistence will be evaluated using survival analysis methods.
Measured: 5 years
Laboratory Safety Parameters
Continuous values and proportion of abnormal results in:
- C-reactive protein
- Erythrocyte sedimentation rate
- Aspartate aminotransferase
- Alanine aminotransferase
- Serum creatinine
- Lipid profile
Measured: 5 years
Factors Associated With Clinical Response
Association between demographic and clinical factors (age, sex, body mass index, baseline disease severity, prior biologic exposure, comorbidities, smoking status, disease duration) and achievement of clinical response (Psoriasis Area and Severity Index 90 or remission in psoriatic arthritis).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (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.
- 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
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Caja Costarricense de Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniel Barquero Orias, Caja Costarricense de Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448402
- Sponsor's protocol ID
- CEC HCG 13-2025
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Accordingly to protocol
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System
- ClinicalTrials.gov ID
- NCT07448402
- Acronym / sponsor ID
- CEC HCG 13-2025
- Conditions
- Psoriasis, Psoriasis Arthritis, Psoriasis (PsO)
- Keywords
- Psoriasis, IL-23, Registry, Costa Rica
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Caja Costarricense de Seguro SocialOther government
- Study start
- May 2026 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 4 Mar 2026 (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.
The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:
- Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
- What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
- Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.
Detailed description
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic inflammatory condition with substantial clinical and functional impact. Although IL-23 inhibitors such as guselkumab and risankizumab have shown high efficacy and favorable safety in international trials, real-world evidence in Latin America-and particularly Costa Rica-is limited. Differences in comorbidities, population genetics, access to therapy, and health-system factors may influence treatment response and safety outcomes.
This national observational registry is designed to generate standardized real-world data on patients with psoriatic disease treated with IL-23 inhibitors within the Costa Rican public health system. The registry will collect demographic and clinical characteristics, dermatologic and rheumatologic disease activity scores, treatment patterns, persistence, and adverse events over time. The resulting evidence will support clinical decision-making, optimize therapeutic strategies, and inform national health policy regarding biologic therapies for psoriatic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of adolescents and adults (≥12 years) with psoriatic disease receiving IL-23 inhibitors within the Costa Rican public health system. This real-world national cohort includes patients with both cutaneous psoriasis and psoriatic arthritis across participating centers. The registry aims to capture the full treated population over time to describe clinical evolution, treatment response, safety, persistence, and associated comorbidities in the national context.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of psoriatic disease, including psoriasis (any clinical variant) and/or psoriatic arthritis based on rheumatologic criteria.
- Receiving IL-23 inhibitor therapy (guselkumab or risankizumab).
- Treated within participating Costa Rican public health centers.
- Availability of sufficient clinical records to complete registry data (history, follow-up, labs).
- Age ≥12 years, any sex.
Key exclusion criteria (1 listed)
- None specified (all patients meeting inclusion criteria are eligible).
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 |
|---|---|---|
| Guselkumab (GUS)Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immune responses. This mechanism distinguishes them from IL-12/23 inhibitors (p40 blockade) and IL-17 inhibitors (downstream cytokine inhibition). IL-23 inhibitors also differ in dosing interval (every 8-12 weeks) and safety profile, with lower candidiasis risk than IL-17 blockade and different infection patterns than TNF-α inhibitors. This national registry specifically evaluates real-world effectiveness, safety, and treatment persistence of IL-23 inhibitors. | Biological | – |
| Risankizumab (RISA)Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immune responses. This mechanism distinguishes them from IL-12/23 inhibitors (p40 blockade) and IL-17 inhibitors (downstream cytokine inhibition). IL-23 inhibitors also differ in dosing interval (every 8-12 weeks) and safety profile, with lower candidiasis risk than IL-17 blockade and different infection patterns than TNF-α inhibitors. This national registry specifically evaluates real-world effectiveness, safety, and treatment persistence of IL-23 inhibitors. | Biological | – |
Primary outcome
Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease
Time frame: 5 years
Proportion of patients achieving: 1. Psoriasis Area and Severity Index 75, 90, and 100 response 2. Dermatology Life Quality Index score of 0 or 1 3. Disease Activity in Psoriatic Arthritis.
Safety of Interleukin-23 Inhibitors
Time frame: 5 years
Incidence rate of adverse events and serious adverse events, including: * Serious infections * Hospitalizations * New malignancy * Thrombotic events * Injection-site reactions * Treatment discontinuation due to adverse events
5 secondary outcomes
Change in Psoriasis Severity
Time frame: 5 years
Articular Disease Activity
Time frame: 5 years
Treatment Persistence
Time frame: 5 years
Laboratory Safety Parameters
Time frame: 5 years
Factors Associated With Clinical Response
Time frame: 5 years
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 9 Mar 2026.
- Individual participant dataSharing planned: No. Accordingly to protocol
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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.
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 Psoriasis Arthritis, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Mar 2026. 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 Costa Rica. 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 Daniel E Barquero-Orias, Dermatologist (+506 8341026, debarque@ccss.sa.cr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease (time frame: 5 years). 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?
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 9 Mar 2026.