Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:24 PM
Study NCT ID:
NCT07448402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588857', 'term': 'guselkumab'}, {'id': 'C000601773', 'term': 'risankizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease', 'timeFrame': '5 years', 'description': 'Proportion of patients achieving:\n\n1. Psoriasis Area and Severity Index 75, 90, and 100 response\n2. Dermatology Life Quality Index score of 0 or 1\n3. Disease Activity in Psoriatic Arthritis.'}, {'measure': 'Safety of Interleukin-23 Inhibitors', 'timeFrame': '5 years', 'description': 'Incidence rate of adverse events and serious adverse events, including:\n\n* Serious infections\n* Hospitalizations\n* New malignancy\n* Thrombotic events\n* Injection-site reactions\n* Treatment discontinuation due to adverse events'}], 'secondaryOutcomes': [{'measure': 'Change in Psoriasis Severity', 'timeFrame': '5 years', 'description': 'Absolute and relative change in:\n\n* Psoriasis Area and Severity Index\n* Body Surface Area affected\n* Dermatology Life Quality Index score'}, {'measure': 'Articular Disease Activity', 'timeFrame': '5 years', 'description': '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.'}, {'measure': 'Treatment Persistence', 'timeFrame': '5 years', 'description': 'Time in months from initiation of guselkumab or risankizumab to treatment discontinuation for any reason. Persistence will be evaluated using survival analysis methods.'}, {'measure': 'Laboratory Safety Parameters', 'timeFrame': '5 years', 'description': 'Continuous values and proportion of abnormal results in:\n\n* C-reactive protein\n* Erythrocyte sedimentation rate\n* Aspartate aminotransferase\n* Alanine aminotransferase\n* Serum creatinine\n* Lipid profile'}, {'measure': 'Factors Associated With Clinical Response', 'timeFrame': '5 years', 'description': '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).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'IL-23', 'Registry', 'Costa Rica'], 'conditions': ['Psoriasis', 'Psoriasis Arthritis', 'Psoriasis (PsO)']}, 'descriptionModule': {'briefSummary': '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:\n\n* Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?\n* What is the safety profile and treatment persistence of IL-23 inhibitors in this population?\n* 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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': 'All', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of psoriatic disease, including psoriasis (any clinical variant) and/or psoriatic arthritis based on rheumatologic criteria.\n* Receiving IL-23 inhibitor therapy (guselkumab or risankizumab).\n* Treated within participating Costa Rican public health centers.\n* Availability of sufficient clinical records to complete registry data (history, follow-up, labs).\n* Age ≥12 years, any sex.\n\nExclusion Criteria:\n\n* None specified (all patients meeting inclusion criteria are eligible).'}, 'identificationModule': {'nctId': 'NCT07448402', 'briefTitle': 'Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Caja Costarricense de Seguro Social'}, 'officialTitle': 'National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System', 'orgStudyIdInfo': {'id': 'CEC HCG 13-2025'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Guselkumab (GUS)', 'type': 'BIOLOGICAL', 'description': '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).\n\nIL-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.'}, {'name': 'Risankizumab (RISA)', 'type': 'BIOLOGICAL', 'description': '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).\n\nIL-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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40901', 'city': 'San José', 'state': 'Provincia de San José', 'country': 'Costa Rica', 'contacts': [{'name': 'Daniel E Barquero-Orias, Dermatologist', 'role': 'CONTACT', 'email': 'debarque@ccss.sa.cr', 'phone': '+506 83411026'}], 'facility': 'Caja Costarricense del Seguro Social', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}], 'centralContacts': [{'name': 'Daniel E Barquero-Orias, Dermatologist', 'role': 'CONTACT', 'email': 'debarque@ccss.sa.cr', 'phone': '+506 8341026'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Accordingly to protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caja Costarricense de Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniel Barquero Orias', 'investigatorAffiliation': 'Caja Costarricense de Seguro Social'}}}}