A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

NCT ID: NCT03818035

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2025-01-07

Brief Summary

The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part 2: Guselkumab q8w and Guselkumab q16w

Eligible participants from Part 1 will continue to participate in Part 2. Participants (super responder \[SRe\]) with a Psoriasis Area and Severity Index (PASI) score = 0 at weeks 20 and 28 will be randomized to guselkumab 100 mg every 8 weeks (q8w) (group 2a) or guselkumab 100 mg q16w (group 2b), at weeks 28 to 60. Group 2b will receive placebo injection at weeks 28, 44 and 60 to keep the comparison double blind. Participants losing control of disease (PASI score \>5) during study Part 2 (until week 60), will enter the re-treatment arm (group 2d) and receive guselkumab 100mg q8w (at re-treatment week 0), followed by administration at re-treatment-weeks 8 and 16.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.

Part 2: Guselkumab q8w

Participants (Non SRe) in group 2c with a PASI score greater than (\>) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.

Placebo Injection

Intervention Type: DRUG

Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.

Part 3: Guselkumab Withdrawal

Participants from groups 2a and 2b with a PASI score \<3 at week 68 will be included in Part 3 (group 3a and 3b) and be withdrawn from guselkumab. Study visits will be conducted every 12 weeks until week 220 (follow-up). Participants with fluctuating disease (PASI score greater than or equal to \[\>=\] 3) at week 68 or PASI \>5 (participants losing control of disease) at any visit during part 3 after week 68 will get an opportunity to enter the re-treatment-arm (group 3c) in which participants will receive three guselkumab injections of 100 mg q8w.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.

Part 1: Guselkumab

Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.

Interventions

Guselkumab

Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.

Intervention Type: DRUG

Placebo Injection

Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.

Intervention Type: DRUG

Other Intervention Names

TREMFYA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Haut- und Laserzentrum Heidelberg

Heidelberg, , Germany

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Hautarztpraxis Offers/Adamini

Ibbenbueren, , Germany

Universitatsklinikum Jena

Jena, , Germany

MensingDerma research GmbH

Hamburg, , Germany

Die Hautklinik Hanau

Hanau, , Germany

Hopital Prive d'Antony

Antony, , France

Centre Hospitalier d'Auxerre

Auxerre, , France

Polyclinique Reims Bezanne - De Courlancy

Bezanne, , France

Centre Hospitalier Le Mans

Le Mans, , France

Hôpital Edouard Herriot

Lyon, , France

Le Bateau Blanc

Martigues, , France

CHU Nantes

Nantes, , France

CHU de Nice Hopital de l Archet

Nice, , France

CHU Rouen

Rouen, , France

HIA se Sainte-Anne - Toulon

Toulon, , France

CHU Toulouse

Toulouse, , France

Universitätsklinikum Aachen

Aachen, , Germany

DermaManagement Augsburg GmbH

Augsburg, , Germany

Klinikum Augsburg

Augsburg, , Germany

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Hautmedizin Bad Soden

Bad Soden am Taunus, , Germany

Charite CCM, Dermatologie

Berlin, , Germany

Vivantes Klinikum Im Friedrichshain

Berlin, , Germany

Rothhaar Studien GmbH

Berlin, , Germany

ISA - Interdisciplinary Study Association GmbH

Berlin, , Germany

Hautarztpraxis

Berlin, , Germany

Hautarztpraxis Dr.Wildfeuer

Berlin, , Germany

Hautarztpraxis

Berlin, , Germany

Praxis 'Haut Pur'

Berlin, , Germany

Klinikum Bielefeld Rosenhoehe

Bielefeld, , Germany

Katholisches Klinikum Bochum gGmbH

Bochum, , Germany

Niesmann & Othlinghaus GbR

Bochum, , Germany

MVZ Dermatologisches Zentrum Bonn GmbH

Bonn, , Germany

Universitatsklinikum Bonn

Bonn, , Germany

Hautarztpraxis

Borna, , Germany

Hautarztpraxis

Bramsche, , Germany

Derma Nord

Bremen, , Germany

Universitaetsklinikum Koeln

Cologne, , Germany

Klinikum Darmstadt GmbH - Hautklinik

Darmstadt, , Germany

Rosenpark Research GmbH

Darmstadt, , Germany

Klinische Forschung Dresden GmbH

Dresden, , Germany

Praxis für Dermatologie und Venerologie

Dresden, , Germany

University Hospital Dresden

Dresden, , Germany

Pro Derma

Dülmen, , Germany

Privatpraxis Dr. Hilton & Partner

Düsseldorf, , Germany

Universitatsklinikum Dusseldorf

Düsseldorf, , Germany

Universitaetsklinik Erlangen

Erlangen, , Germany

Universitaetsklinikum Essen

Essen, , Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, , Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, , Germany

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, , Germany

SRH Waldklinikum Gera GmbH

Gera, , Germany

Hautarztpraxis Brau/Groß

Giessen, , Germany

Universitatsmedizin Gottingen

Göttingen, , Germany

Universitaetsklinik Hamburg-Eppendorf

Hamburg, , Germany

Klinische Forschung Hamburg

Hamburg, , Germany

Dermatologikum Hamburg Gmbh

Hamburg, , Germany

SCIderm GmbH

Hamburg, , Germany

Universitatsklinikum Schleswig Holstein Kiel

Kiel, , Germany

MVZ DermaKiel GmbH

Kiel, , Germany

Praxis Dr. med. Beate Schwarz - Germany

Langenau, , Germany

Universitatsklinikum Leipzig AOR

Leipzig, , Germany

Hautarztpraxis

Lingen, , Germany

Otto Von Guericke Universität Magdeburg

Magdeburg, , Germany

Gemeinschaftspraxis Scholz/Sebastian/Schilling

Mahlow, , Germany

Hautarztzentrum am MDZ

Mainz, , Germany

Universitaetsmedizin Mainz

Mainz, , Germany

Universitaetsklinikum Mannheim

Mannheim, , Germany

Hautarztpraxis

Memmingen, , Germany

Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR

Mönchengladbach, , Germany

Technische Universitaet Muenchen

München, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Klinikum Oldenburg

Oldenburg, , Germany

Klinische Forschung Osnabrück

Osnabrück, , Germany

Hautarztpraxis

Potsdam, , Germany

Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay

Quedlinburg, , Germany

Universitaetsklinikum Regensburg

Regensburg, , Germany

Hautarztpraxis Mortazawi

Remscheid, , Germany

Klinische Forschung Schwerin GmbH

Schwerin, , Germany

Company for Medical Study & Service Selters

Selters, , Germany

Hautarztpraxis Dr. Leitz & Kollegen

Stuttgart, , Germany

Hautarztpraxis am Loewenmarkt

Stuttgart, , Germany

Universitatsklinikum Tubingen

Tübingen, , Germany

Universitatsklinikum Ulm

Ulm, , Germany

Hautarztpraxis Kock

Vechta, , Germany

Centrovital

Witten, , Germany

HELIOS Klinikum Wuppertal GmbH

Wuppertal, , Germany

CentroDerm GmbH

Wuppertal, , Germany

Universitatsklinikum Wurzburg

Würzburg, , Germany

Countries

France; Germany

References

Eyerich K, Asadullah K, Pinter A, Weisenseel P, Reich K, Paul C, Sabat R, Wolk K, Eyerich S, Lauffer F, Angsana J, Taut FJH, Kohler K, Chen Y, Sendecki J, Leung MWL, Wegner S, Personke Y, Gomez M, Kruger N, Tabori S, Schakel K. Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis: The GUIDE Randomized Clinical Trial. JAMA Dermatol. 2024 Sep 1;160(9):953-963. doi: 10.1001/jamadermatol.2024.2463.

Reference Type: DERIVED

PMID: 39083288 (View on PubMed)

Eyerich K, Weisenseel P, Pinter A, Schakel K, Asadullah K, Wegner S, Munoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.

Reference Type: DERIVED

PMID: 34518264 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-001238-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO1959PSO3012

Identifier Type: OTHER

Identifier Source: secondary_id

2023-508424-34-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108514

Identifier Type: -

Identifier Source: org_study_id