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Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

NCT07448402 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-09

No results posted yet for this study

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. 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.

Conditions

  • Psoriasis
  • Psoriasis Arthritis
  • Psoriasis (PsO)

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Caja Costarricense de Seguro Social

    lead OTHER_GOV

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2031-05-31
Completion
2031-05-31
FDA Drug
Yes

Countries

  • Costa Rica

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448402 on ClinicalTrials.gov