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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Psoriasis

Treatments: Drug: Guselkumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04439526

CR108761

CNTO1959PSO4013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

356 participants in 2 patient groups

Participants with Facial Psoriasis

Description:

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

Treatment:

Drug: Guselkumab

Participants with Genital Psoriasis

Description:

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

Treatment:

Drug: Guselkumab