Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
: 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.
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.