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A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis | Clinical Trials | Clareo Health

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A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

Observational Study on GUselkumab: Effectiveness and Impact on quaLity of LIfe in naïVE or Bio Experienced Patients With Regional (Facial and Genital) Psoriasis (GULLIVER Study)

NCT04439526•Janssen-Cilag S.p.A.

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effectiveness profile of guselkumab used in a real-life setting in participants with moderate facial and/or genital psoriasis. Effectiveness will be evaluated using the static Physicians Global Assessment (sPGA) for the facial region and the sPGA for the genital region.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants included in the study:
•must have a first or confirmed diagnosis of psoriasis, requiring systemic treatment with significant involvement (defined as a Static Physician's Global Assessment \[sPGA\] score greater than or equal to \[\>=\] 3) involving the facial and/or genital regions
•must have started treatment according to the approved indication as described in the current version of summary of product characteristics (SmPC) of the product approved in Italy. Enrollment may occur at any time after the first injection of guselkumab but before completion of the next visit at week 4 or 12 as scheduled according to common clinical practice
•must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria

•Participants will be excluded from the study if they:
•have any contraindication to the use of guselkumab, as stated in the current SmPC of the product approved in Italy
•received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of guselkumab treatment
•are currently enrolled in another clinical trial or investigational study
•are currently enrolled in an observational study sponsored or managed by a Janssen company
•participant unable to read, to write, to understand and sign the informed consent form (ICF)

Locations (38)

Policlinico di Bari Ospedale Giovanni XXIII

Bari, Italy

Policlinico Sant'Orsola Malpighi

Bologna, Italy

Ospedale San Giovanni di Dio

Cagliari, Italy

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, Italy

Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona

Cava de' Tirreni, Italy

Università D'Annunzio

Chieti, Italy

Azienda Ospedaliero Universitaria di Ferrara

Cona, Italy

Ospedale Sant'Antonio Abate

Erice, Italy

Azienda Sanitaria di Firenze-Ospedale Piero Palagi

Florence, Italy

IRCCS Aor San Martino IST

Genova, Italy

Key Dates

Start Date

June 10, 2020

Primary Completion Date

November 21, 2023

Completion Date

November 21, 2023

Last Updated

January 5, 2024

Enrollment

356

ACTUAL participants

Conditions

Psoriasis

Interventions

Guselkumab

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments