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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04439526
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen-Cilag S.p.A.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen-Cilag S.p.A., Italy Clinical Trial
Principal Investigator Affiliation Janssen-Cilag S.p.A.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

: Participants with Facial Psoriasis

Participants with moderate facial psoriasis who are being treated with guselkumab in real world practice will be observed in this study.

: Participants with Genital Psoriasis

Participants with moderate genital psoriasis who are being treated with guselkumab in real world practice will be observed in this study.

Interventions

Drug: - Guselkumab

Participants with moderate facial and/or genital psoriasis treated with guselkumab (as prescribed by their physician) in real world practice will be observed in this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ospedale San Donato, Arezzo, Italy

Status

Not yet recruiting

Address

Ospedale San Donato

Arezzo, , 52100

Bari, Italy

Status

Not yet recruiting

Address

Policlinico di Bari Ospedale Giovanni XXIII

Bari, , 70124

Policlinico Sant'Orsola Malpighi, Bologna, Italy

Status

Not yet recruiting

Address

Policlinico Sant'Orsola Malpighi

Bologna, , 40138

Ospedale San Giovanni di Dio, Cagliari, Italy

Status

Not yet recruiting

Address

Ospedale San Giovanni di Dio

Cagliari, , 09124

Catania, Italy

Status

Not yet recruiting

Address

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, , 95123

Università D'Annunzio, Chieti, Italy

Status

Not yet recruiting

Address

Università D'Annunzio

Chieti, , 66100

Firenze, Italy

Status

Not yet recruiting

Address

Azienda Sanitaria di Firenze-Ospedale Piero Palagi

Firenze, , 50125

IRCCS Aor San Martino IST, Genova, Italy

Status

Not yet recruiting

Address

IRCCS Aor San Martino IST

Genova, , 16132

Ospedale San Salvatore, L'Aquila, Italy

Status

Not yet recruiting

Address

Ospedale San Salvatore

L'Aquila, , 67100

Messina, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, , 98125

Milano, Italy

Status

Not yet recruiting

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, , 20122

Modena, Italy

Status

Not yet recruiting

Address

Az. Ospedaliero - Universitaria di Modena

Modena, , 41124

Napoli, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

Napoli, , 80131

Napoli, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Federico II

Napoli, , 80131

Novara, Italy

Status

Not yet recruiting

Address

Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

Novara, , 28100

Padova, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria di Padova

Padova, , 35128

Palermo, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , 90127

Parma, Italy

Status

Not yet recruiting

Address

Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma

Parma, , 43126

Ospedale S. Maria Della Misericordia, Perugia, Italy

Status

Not yet recruiting

Address

Ospedale S. Maria Della Misericordia

Perugia, , 06129

Azienda Ospedaliero Universitaria Pisana, Pisa, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliero Universitaria Pisana

Pisa, , 56126

Reggio Calabria, Italy

Status

Not yet recruiting

Address

Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

Reggio Calabria, , 89124

Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy

Status

Not yet recruiting

Address

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, , 42123

ISG San Gallicano, Roma, Italy

Status

Recruiting

Address

ISG San Gallicano

Roma, , 00144

AOU Policlinico Umberto I, Roma, Italy

Status

Not yet recruiting

Address

AOU Policlinico Umberto I

Roma, , 00161

Istituto Dermopatico dell'Immacolata, Roma, Italy

Status

Not yet recruiting

Address

Istituto Dermopatico dell'Immacolata

Roma, , 00167

Policinico A Gemelli, Roma, Italy

Status

Not yet recruiting

Address

Policinico A Gemelli

Roma, , 00168

Policlinico Tor Vergata, Roma, Italy

Status

Not yet recruiting

Address

Policlinico Tor Vergata

Roma, , 00183

Istituto Clinico Humanitas, Rozzano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano, , 20089

Siena, Italy

Status

Not yet recruiting

Address

A.O. Universitaria Senese- Ospedale Santa Maria alle Scotte

Siena, , 53100

Azienda Ospedaliera Santa Maria, Terni, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Santa Maria

Terni, , 05100

Ospedale Alfredo Fiorini, Terracina, Italy

Status

Not yet recruiting

Address

Ospedale Alfredo Fiorini

Terracina, , 04019

Torino, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

Torino, , 10126

Torrette Di Ancona, Italy

Status

Not yet recruiting

Address

A.O. Universitaria Ospedali Riuniti di Ancona

Torrette Di Ancona, , 60030

Trento, Italy

Status

Not yet recruiting

Address

Azienda Provinciale per i Servizi Sanitari - Ospedale di Trento - Presidio Ospedaliero S. Chiara

Trento, , 38122

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