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New hope for Tough-to-Treat psoriasis: guselkumab targets sensitive areas

NCT ID NCT06039189

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed phase 3 trial tested the drug guselkumab against a placebo in 338 adults with moderate plaque psoriasis covering only 2-15% of their body but including special sites like the scalp, face, or genitals. The goal was to see if guselkumab could clear or nearly clear psoriasis at these tricky spots by week 16. Results are available and may help guide treatment for this specific group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Guselkumab (Tremfya)
What this could lead to
If successful, this could confirm guselkumab as a treatment option for people with moderate psoriasis that affects small body areas but includes sensitive spots like the scalp or genitals.
What could go wrong
This is a completed phase 3 trial, so results are available. However, the benefit may not apply to all patients, and side effects like infections or allergic reactions are possible with guselkumab.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

338 people

The number who actually took part.

Started

Aug 2023

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization * 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) * 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 * 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) * 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

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate plaque psoriasis

Contacts and locations

Locations

  • Accellacare Research of Cary

    Cary, North Carolina, 27511, United States

  • Acclaim Dermatology

    Sugar Land, Texas, 77479, United States

  • Apex Dermatology Mayfield Heights

    Mayfield Heights, Ohio, 44124, United States

  • Arlington Center for Dermatology

    Arlington, Texas, 76011, United States

  • Atlanta Biomedical Clinical Research

    Atlanta, Georgia, 303331, United States

  • Bare Dermatology

    Dallas, Texas, 75235, United States

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2, Canada

  • Bellair Dermatology

    Bellaire, Texas, 77401, United States

  • Bexley dermatology research

    Bexley, Ohio, 43209, United States

  • Brunswick Dermatology Center

    Fredericton, New Brunswick, E3B 1G9, Canada

  • CCA Medical Research Corporation

    Ajax, Ontario, L1S7K8, Canada

  • Cahaba Research Inc

    Birmingham, Alabama, 35244, United States

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024, United States

  • Canadian Dermatology Center

    Toronto, Ontario, M3B 0A7, Canada

  • Center for Clinical Studies

    Houston, Texas, 77004, United States

  • Clinical Science Institute

    Santa Monica, California, 90404, United States

  • Darst Dermatology

    Charlotte, North Carolina, 28277, United States

  • DermAssociates, PC

    Rockville, Maryland, 20850, United States

  • DermCare, LLC

    Quincy, Massachusetts, 02169, United States

  • Dermatology and Laser Center of Charleston

    Charleston, South Carolina, 29414, United States

  • Dermatrials Research

    Hamilton, Ontario, L8N 1Y2, Canada

  • Dr Wei Jing Loo Medicine Professional Corporation

    London, Ontario, N6H 5L5, Canada

  • Dr. Chih ho Hong Medical

    Surrey, British Columbia, V3R 6A7, Canada

  • Enverus Medical

    Surrey, British Columbia, V3V 0C6, Canada

  • FACET Dermatology

    Toronto, Ontario, M4E 2Y9, Canada

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • Florida Academic Dermatology Centers

    Coral Gables, Florida, 33134, United States

  • Frontier Derm Partners CRO, LLC

    Mill Creek, Washington, 98102, United States

  • Glick Research Institute

    Margate, Florida, 33063, United States

  • Henry Ford Medical Center

    West Bloomfield, Michigan, 48322, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10003, United States

  • JRB Research Inc

    Ottawa, Ontario, K1H 7X3, Canada

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario, N2J 1C4, Canada

  • Kindred Hair and Skin Center

    Columbia, Maryland, 21045, United States

  • Lawrence J Green MD LLC

    Rockville, Maryland, 20850, United States

  • Markowitz Medical OptiSkin

    New York, New York, 10128, United States

  • Menter Dermatology Research Institute

    Dallas, Texas, 75246, United States

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135, United States

  • Miami VA Healthcare System

    Miami, Florida, 33124, United States

  • Modern Research Associates PLLC

    Dallas, Texas, 75231, United States

  • Nashville Skin: Comprehensive Dermatology Center

    Nashville, Tennessee, 37212, United States

  • North York Research Inc

    North York, Ontario, M2M 4J5, Canada

  • Palmetto Clinical Trial Services, LLC

    Fountain Inn, South Carolina, 29644, United States

  • Piedmont Plastic Surgery and Dermatology

    Huntersville, North Carolina, 28078, United States

  • Practice Wang

    Riverside, California, 92505, United States

  • Progressive Clinical Research

    San Antonio, Texas, 78229, United States

  • Rehlen, Bartlow, Goodman and Baron Dermatology Group

    Santa Ana, California, 92701, United States

  • Rejuvenation Dermatology Clinic Edmonton Downtown

    Edmonton, Alberta, T5J 3S9, Canada

  • Remington Davis Inc

    Columbus, Ohio, 43215, United States

  • Research Toronto

    Toronto, Ontario, M4W 2N2, Canada

  • Revival Research

    Doral, Florida, 33122, United States

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1, Canada

  • Suzanne Bruce and Associates - The Center for Skin Research

    Houston, Texas, 77056-4132, United States

  • Tennessee Clinical Research Center

    Nashville, Tennessee, 37215, United States

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • The Centre de recherche Saint-Louis

    Québec, Quebec, G1W 4R4, Canada

  • Therapeutics Clinical Research

    San Diego, California, 92123, United States

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8, Canada

  • Tory P Sullivan M D PA

    North Miami Beach, Florida, 33162, United States

  • Total Dermatology

    Birmingham, Alabama, 35203, United States

  • TrueBlue Clinical Research

    Brandon, Florida, 33511, United States

  • University of Conn Health Center

    Farmington, Connecticut, 06030, United States

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2, Canada

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4, Canada

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