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Can psoriasis patients skip more shots? new trial tests extended guselkumab dosing

NCT ID NCT03818035

Disease control Sponsor: Janssen-Cilag International NV 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether people with moderate-to-severe plaque psoriasis who achieve complete skin clearance after 20 weeks of guselkumab (Tremfya) can maintain that control with injections every 16 weeks instead of every 8 weeks. About 880 participants were enrolled, and the main goal was to see if the extended schedule kept psoriasis under control through week 68. The trial also looked at how quickly symptoms improved in people with shorter versus longer disease history.

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 allow some psoriasis patients to maintain clear skin with fewer injections, reducing treatment burden.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. Extended dosing might not work for everyone, and some may lose disease control.

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

880 people

The number who actually took part.

Started

Feb 2019

Finished

Jan 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: * Has a disease duration of plaque psoriasis of either less than or equal to (\<=2) years or (greater than (\>2) years calculated from date at which first symptoms \[plaque\] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration \<=2 years * Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score \>10 or affected body surface area (BSA) \>10%) and additionally a Dermatology Life Quality Index (DLQI) score \>10 at baseline (week 0) * Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination * Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug * Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug Exclusion Criteria: * Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab \[MK3222\], risankizumab \[BI-655066\]) * Has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug. * Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline * Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug * Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug

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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.

Psoriasis

Contacts and locations

Locations

  • CHU Nantes

    Nantes, 44093, France

  • CHU Rouen

    Rouen, 76000, France

  • CHU Toulouse

    Toulouse, 31059, France

  • CHU de Nice Hopital de l Archet

    Nice, 06202, France

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

  • Centre Hospitalier d'Auxerre

    Auxerre, 89011, France

  • CentroDerm GmbH

    Wuppertal, 42287, Germany

  • Centrovital

    Witten, 58453, Germany

  • Charite CCM, Dermatologie

    Berlin, 10117, Germany

  • Company for Medical Study & Service Selters

    Selters, 56242, Germany

  • Derma Nord

    Bremen, 28779, Germany

  • Derma-Study-Center Friedrichshafen GmbH

    Friedrichshafen, 88045, Germany

  • DermaManagement Augsburg GmbH

    Augsburg, 86179, Germany

  • Dermatologikum Hamburg Gmbh

    Hamburg, 20354, Germany

  • Die Hautklinik Hanau

    Hanau, 63450, Germany

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455, Germany

  • Gemeinschaftspraxis Scholz/Sebastian/Schilling

    Mahlow, 15831, Germany

  • HELIOS Klinikum Wuppertal GmbH

    Wuppertal, 42283, Germany

  • HIA se Sainte-Anne - Toulon

    Toulon, 83041, France

  • Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay

    Quedlinburg, 06484, Germany

  • Haut- und Laserzentrum Heidelberg

    Heidelberg, 69115, Germany

  • Hautarztpraxis

    Berlin, 12459, Germany

  • Hautarztpraxis

    Berlin, 13597, Germany

  • Hautarztpraxis

    Borna, 04552, Germany

  • Hautarztpraxis

    Bramsche, 49565, Germany

  • Hautarztpraxis

    Lingen, 49809, Germany

  • Hautarztpraxis

    Memmingen, 87700, Germany

  • Hautarztpraxis

    Potsdam, 14467, Germany

  • Hautarztpraxis Brau/Groß

    Giessen, 35390, Germany

  • Hautarztpraxis Dr. Leitz & Kollegen

    Stuttgart, 70178, Germany

  • Hautarztpraxis Dr.Wildfeuer

    Berlin, 13055, Germany

  • Hautarztpraxis Kock

    Vechta, 49377, Germany

  • Hautarztpraxis Mortazawi

    Remscheid, 42897, Germany

  • Hautarztpraxis Offers/Adamini

    Ibbenbueren, 49477, Germany

  • Hautarztpraxis am Loewenmarkt

    Stuttgart, 70499, Germany

  • Hautarztzentrum am MDZ

    Mainz, 55128, Germany

  • Hautmedizin Bad Soden

    Bad Soden am Taunus, 65812, Germany

  • Hopital Prive d'Antony

    Antony, 92160, France

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789, Germany

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791, Germany

  • Klinikum Augsburg

    Augsburg, 86179, Germany

  • Klinikum Bielefeld Rosenhoehe

    Bielefeld, 33647, Germany

  • Klinikum Darmstadt GmbH - Hautklinik

    Darmstadt, 64283, Germany

  • Klinikum Oldenburg

    Oldenburg, 26133, Germany

  • Klinische Forschung Dresden GmbH

    Dresden, 01069, Germany

  • Klinische Forschung Hamburg

    Hamburg, 20253, Germany

  • Klinische Forschung Osnabrück

    Osnabrück, 49074, Germany

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055, Germany

  • Le Bateau Blanc

    Martigues, 13500, France

  • MVZ DermaKiel GmbH

    Kiel, 24148, Germany

  • MVZ Dermatologisches Zentrum Bonn GmbH

    Bonn, 53111, Germany

  • MensingDerma research GmbH

    Hamburg, 22391, Germany

  • Niesmann & Othlinghaus GbR

    Bochum, 44793, Germany

  • Otto Von Guericke Universität Magdeburg

    Magdeburg, 39120, Germany

  • Polyclinique Reims Bezanne - De Courlancy

    Bezanne, 51430, France

  • Praxis 'Haut Pur'

    Berlin, 13597, Germany

  • Praxis Dr. med. Beate Schwarz - Germany

    Langenau, 89129, Germany

  • Praxis für Dermatologie und Venerologie

    Dresden, 01097, Germany

  • Privatpraxis Dr. Hilton & Partner

    Düsseldorf, 40212, Germany

  • Pro Derma

    Dülmen, 48249, Germany

  • Rosenpark Research GmbH

    Darmstadt, 64283, Germany

  • Rothhaar Studien GmbH

    Berlin, 10783, Germany

  • SCIderm GmbH

    Hamburg, 20537, Germany

  • SRH Waldklinikum Gera GmbH

    Gera, 07548, Germany

  • Technische Universitaet Muenchen

    München, 80802, Germany

  • Universitaetsklinik Erlangen

    Erlangen, 91054, Germany

  • Universitaetsklinik Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Essen

    Essen, 45122, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Mannheim

    Mannheim, 68167, Germany

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitaetsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitaetsmedizin Mainz

    Mainz, 55131, Germany

  • Universitatsklinikum Bonn

    Bonn, 53127, Germany

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225, Germany

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60590, Germany

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79104, Germany

  • Universitatsklinikum Jena

    Jena, 07745, Germany

  • Universitatsklinikum Leipzig AOR

    Leipzig, 04103, Germany

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105, Germany

  • Universitatsklinikum Tubingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Ulm

    Ulm, 89081, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • Universitatsmedizin Gottingen

    Göttingen, 37075, Germany

  • University Hospital Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Aachen

    Aachen, 52074, Germany

  • Vivantes Klinikum Im Friedrichshain

    Berlin, 10119, Germany

  • Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR

    Mönchengladbach, 41061, Germany

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