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

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    Janssen-Cilag S.p.A.
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Updated on 16 February 2024
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guselkumab
psoriasis

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.

Details
Condition Psoriasis
Age 18years - 100years
Treatment Guselkumab
Clinical Study IdentifierNCT04439526
SponsorJanssen-Cilag S.p.A.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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