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|
- - Should have all the following: A confirmed diagnosis of moderate-to-severe
palmoplantar-non-pustular psoriasis with palm and/or sole involvement and at least one
plaque at a body site other than the palms and soles for at least 6 months, to confirm
a diagnosis of chronic psoriasis; psoriatic area and severity index (PASI) score
greater than or equal to (>=) 3 and less than (<) 10 at screening and at baseline;
Palmoplantar Investigator Global Assessment (ppIGA) score >=3 at screening and at
- Should be eligible to receive biological treatments; only participants who are naive
to biological treatments can be included
- A woman of childbearing potential must have a negative urine pregnancy test at
screening and at Week 0
- Agree not to receive a live virus or live bacterial vaccination during the study, or
within 12 weeks after the last administration of study intervention
- Agree to avoid prolonged sun exposure and agree not to use tanning booths or other
ultraviolet (UV) light sources from the first administration of study intervention
through 12 weeks after the final dose of study intervention (Week 56)
Exclusion Criteria:- Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than plaque-type psoriasis (e.
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 Ltd. Clinical Trial|
|Principal Investigator Affiliation||Janssen-Cilag Ltd.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||France, Germany, Italy, Spain, United Kingdom|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Chronic plaque psoriasis is the most common form of psoriatic skin disease; however, there is growing evidence that other variants including scalp, nail, inverse, and palmoplantar psoriasis are prevalent, undertreated, and are correlated with an increased risk of psoriatic arthritis that may result in significant morbidity with functional impairment and greater impairment in quality of life. Therefore, the main aim of the study is to provide robust efficacy and safety data on guselkumab treatment for palmoplantar non-pustular psoriasis. The study comprises of a Screening Phase (4 Weeks [Week -4 to 0]), a Treatment Phase (up to Week 48) and a post-treatment follow-up phase (up to Week 56). Key efficacy assessments include physician assessments and patient-reported outcomes questionnaires. Safety evaluations will include 12-lead electrocardiogram at baseline, pregnancy testing and monitoring of vital signs at all visits and recording of adverse events throughout the study. Also, participants will be evaluated for signs and symptoms of active tuberculosis at all visits including follow-up visit. Biomarker assessments will include the evaluation of relevant markers in serum for all participants. The study will have an overall duration of 56 weeks.
Experimental: Guselkumab Group
Participants will receive guselkumab 100 mg SC injections at Weeks 0, 4, 12 and placebo subcutaneous (SC) injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injections at Weeks 20, 28, 36, and 44 in open-label phase.
Placebo Comparator: Placebo Group
Participants will receive placebo SC injection at Weeks 0, 4, 12 and guselkumab 100 mg SC injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injection at Week 20, 28, 36, and 44 in open-label phase.
Drug: - Guselkumab 100 mg
Guselkumab 100 mg will be administered as SC injection.
Drug: - Placebo
Placebo will be administered as SC injection.
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.