NCT06039189CompletedPhase 3
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 338 (actual)
- First submitted
- 9 Sept 2023
- Start date
- 24 Aug 2023
- Primary completion date
- 14 Apr 2025
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Psoriasis
- NCT number
- NCT06039189
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 338
- From 24 Aug 2023 to the primary completion date, 14 Apr 2025
- 64 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
Other illness
- Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Lab values
- Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Other
- Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
- For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
Who the study is looking for
- All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
- All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (\>=) 3, face with facial psoriasis IGA \>=3, intertriginous with intertriginous psoriasis IGA \>=3, or genital with static physician global assessment of genitalia (sPGA-G) \>=3
- All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
- All participants be a candidate for phototherapy or systemic treatment for psoriasis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (64)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CCA Medical Research Corporation Coordinator of this site? Confirm its status | Ajax | Canada | Unknown status |
| Simcoderm Medical and Surgical Dermatology Centre Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| Beacon Dermatology Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Rejuvenation Dermatology Clinic Edmonton Downtown Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Brunswick Dermatology Center Coordinator of this site? Confirm its status | Fredericton | Canada | Unknown status |
| Dermatrials Research Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Dr Wei Jing Loo Medicine Professional Corporation Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| North York Research Inc Coordinator of this site? Confirm its status | North York | Canada | Unknown status |
| JRB Research Inc. Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| The Centre de recherche Saint-Louis Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Dr. Chih ho Hong Medical Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Enverus Medical Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Research Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Canadian Dermatology Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| FACET Dermatology Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Toronto Research Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| K. Papp Clinical Research Inc. Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| Winnipeg Clinic Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Wiseman Dermatology Research Inc. Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Arlington Center for Dermatology Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Atlanta Biomedical Clinical Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Bellair Dermatology Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Bexley Dermatology Research Coordinator of this site? Confirm its status | Bexley | United States | Unknown status |
| Total Dermatology Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Cahaba Research Inc Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| TrueBlue Clinical Research Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Metro Boston Clinical Partners Coordinator of this site? Confirm its status | Brighton | United States | Unknown status |
| Accellacare Research of Cary Coordinator of this site? Confirm its status | Cary | United States | Unknown status |
| Dermatology and Laser Center of Charleston Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Darst Dermatology Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Kindred Hair and Skin Center Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Remington Davis, Inc. Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Florida Academic Dermatology Centers Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Bare Dermatology Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Modern Research Associates Pllc Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Menter Dermatology Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Revival Research Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| California Dermatology & Clinical Research Institute Coordinator of this site? Confirm its status | Encinitas | United States | Unknown status |
| University of Conn Health Center Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| Palmetto Clinical Trial Services, LLC Coordinator of this site? Confirm its status | Fountain Inn | United States | Unknown status |
| First OC Dermatology Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Suzanne Bruce and Associates - The Center for Skin Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Center for Clinical Studies Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Piedmont Plastic Surgery and Dermatology Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| Glick Research Institute Coordinator of this site? Confirm its status | Margate | United States | Unknown status |
| Apex Dermatology Mayfield Heights Coordinator of this site? Confirm its status | Mayfield Heights | United States | Unknown status |
| Miami VA Healthcare System Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Frontier Derm Partners CRO LLC Coordinator of this site? Confirm its status | Mill Creek | United States | Unknown status |
| Nashville Skin: Comprehensive Dermatology Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Tennessee Clinical Research Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Markowitz Medical OptiSkin Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Tory P Sullivan M D PA Coordinator of this site? Confirm its status | North Miami Beach | United States | Unknown status |
| DermCare, LLC Coordinator of this site? Confirm its status | Quincy | United States | Unknown status |
| Practice Wang Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| Lawrence J. Green, MD, LLC Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| DermAssociates, PC Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Progressive Clinical Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Texas Dermatology and Laser Specialists Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Therapeutics Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Rehlen, Bartlow, Goodman and Baron Dermatology Group Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Clinical Science Institute Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Acclaim Dermatology Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Henry Ford Medical Center Coordinator of this site? Confirm its status | West Bloomfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.