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

NCT03818035 | Completed Phase 3 Results FDA Drug

• 4 other identifiers: CR1085142018-001238-16CNTO1959PSO30122023-508424-34-00
• Study Type: interventional
• Target: 880
• Locations: 2 countries
• Sites: 90

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

Outcome Measures

Primary Outcomes (1)

• Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68

  Percentage of participants who achieved an absolute PASI \<3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent \[%\]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.

  Week 68

Secondary Outcomes (16)

• Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score

  Group 1: Week 0 up to Week 28; Group 2c: Week 28 up to Week 68

• Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220

  Group 1: Weeks 20 and 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Weeks 116, 164 and 220

• Group 3a and Group 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Retain Disease Control (Absolute PASI Score < 3)

  From Week 68 up to Week 220

• Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220

  Group 1: Weeks 20, 28; Groups 2a, 2b, 2c: Week 68; Groups 3a, 3b: Weeks 116, 164 and 220

• Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal

  From Week 68 up to Week 220

Study Arms (4)

Part 1: Guselkumab

EXPERIMENTAL

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

Drug: Guselkumab

Part 2: Guselkumab q8w and Guselkumab q16w

EXPERIMENTAL

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.

Drug: Guselkumab

Part 2: Guselkumab q8w

EXPERIMENTAL

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.

Drug: Guselkumab; Drug: Placebo Injection

Part 3: Guselkumab Withdrawal

EXPERIMENTAL

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.

Drug: Guselkumab

Interventions

Guselkumab 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.

Also known as: TREMFYA

Part 1: Guselkumab; Part 2: Guselkumab q8w; Part 2: Guselkumab q8w and Guselkumab q16w; Part 3: Guselkumab Withdrawal

Placebo Injection DRUG

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

Part 2: Guselkumab q8w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (90)

Hopital Prive d'Antony

Antony, 92160, France

Location

Centre Hospitalier d'Auxerre

Auxerre, 89011, France

Location

Polyclinique Reims Bezanne - De Courlancy

Bezanne, 51430, France

Location

Centre Hospitalier Le Mans

Le Mans, 72037, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Le Bateau Blanc

Martigues, 13500, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU de Nice Hopital de l Archet

Nice, 06202, France

Location

CHU Rouen

Rouen, 76000, France

Location

HIA se Sainte-Anne - Toulon

Toulon, 83041, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

DermaManagement Augsburg GmbH

Augsburg, 86179, Germany

Location

Klinikum Augsburg

Augsburg, 86179, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Hautmedizin Bad Soden

Bad Soden am Taunus, 65812, Germany

Location

Charite CCM, Dermatologie

Berlin, 10117, Germany

Location

Vivantes Klinikum Im Friedrichshain

Berlin, 10119, Germany

Location

Rothhaar Studien GmbH

Berlin, 10783, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Hautarztpraxis

Berlin, 12459, Germany

Location

Hautarztpraxis Dr.Wildfeuer

Berlin, 13055, Germany

Location

Hautarztpraxis

Berlin, 13597, Germany

Location

Praxis 'Haut Pur'

Berlin, 13597, Germany

Location

Klinikum Bielefeld Rosenhoehe

Bielefeld, 33647, Germany

Location

Katholisches Klinikum Bochum gGmbH

Bochum, 44791, Germany

Location

Niesmann & Othlinghaus GbR

Bochum, 44793, Germany

Location

MVZ Dermatologisches Zentrum Bonn GmbH

Bonn, 53111, Germany

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Hautarztpraxis

Borna, 04552, Germany

Location

Hautarztpraxis

Bramsche, 49565, Germany

Location

Derma Nord

Bremen, 28779, Germany

Location

Universitaetsklinikum Koeln

Cologne, 50937, Germany

Location

Klinikum Darmstadt GmbH - Hautklinik

Darmstadt, 64283, Germany

Location

Rosenpark Research GmbH

Darmstadt, 64283, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Praxis für Dermatologie und Venerologie

Dresden, 01097, Germany

Location

University Hospital Dresden

Dresden, 01307, Germany

Location

Pro Derma

Dülmen, 48249, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212, Germany

Location

Universitatsklinikum Dusseldorf

Düsseldorf, 40225, Germany

Location

Universitaetsklinik Erlangen

Erlangen, 91054, Germany

Location

Universitaetsklinikum Essen

Essen, 45122, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, 88045, Germany

Location

SRH Waldklinikum Gera GmbH

Gera, 07548, Germany

Location

Hautarztpraxis Brau/Groß

Giessen, 35390, Germany

Location

Universitatsmedizin Gottingen

Göttingen, 37075, Germany

Location

Universitaetsklinik Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Klinische Forschung Hamburg

Hamburg, 20253, Germany

Location

Dermatologikum Hamburg Gmbh

Hamburg, 20354, Germany

Location

SCIderm GmbH

Hamburg, 20537, Germany

Location

MensingDerma research GmbH

Hamburg, 22391, Germany

Location

Die Hautklinik Hanau

Hanau, 63450, Germany

Location

Haut- und Laserzentrum Heidelberg

Heidelberg, 69115, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Hautarztpraxis Offers/Adamini

Ibbenbueren, 49477, Germany

Location

Universitatsklinikum Jena

Jena, 07745, Germany

Location

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105, Germany

Location

MVZ DermaKiel GmbH

Kiel, 24148, Germany

Location

Praxis Dr. med. Beate Schwarz - Germany

Langenau, 89129, Germany

Location

Universitatsklinikum Leipzig AOR

Leipzig, 04103, Germany

Location

Hautarztpraxis

Lingen, 49809, Germany

Location

Otto Von Guericke Universität Magdeburg

Magdeburg, 39120, Germany

Location

Gemeinschaftspraxis Scholz/Sebastian/Schilling

Mahlow, 15831, Germany

Location

Hautarztzentrum am MDZ

Mainz, 55128, Germany

Location

Universitaetsmedizin Mainz

Mainz, 55131, Germany

Location

Universitaetsklinikum Mannheim

Mannheim, 68167, Germany

Location

Hautarztpraxis

Memmingen, 87700, Germany

Location

Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR

Mönchengladbach, 41061, Germany

Location

Technische Universitaet Muenchen

München, 80802, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Klinische Forschung Osnabrück

Osnabrück, 49074, Germany

Location

Hautarztpraxis

Potsdam, 14467, Germany

Location

Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay

Quedlinburg, 06484, Germany

Location

Universitaetsklinikum Regensburg

Regensburg, 93053, Germany

Location

Hautarztpraxis Mortazawi

Remscheid, 42897, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Company for Medical Study & Service Selters

Selters, 56242, Germany

Location

Hautarztpraxis Dr. Leitz & Kollegen

Stuttgart, 70178, Germany

Location

Hautarztpraxis am Loewenmarkt

Stuttgart, 70499, Germany

Location

Universitatsklinikum Tubingen

Tübingen, 72076, Germany

Location

Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Hautarztpraxis Kock

Vechta, 49377, Germany

Location

Centrovital

Witten, 58453, Germany

Location

HELIOS Klinikum Wuppertal GmbH

Wuppertal, 42283, Germany

Location

CentroDerm GmbH

Wuppertal, 42287, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Related Publications (2)

• 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.

  PMID: 39083288 DERIVED

• 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.

  PMID: 34518264 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

There was an interruption of enrollment due to Corona Pandemic.

Results Point of Contact

• Title: GUIDE-Study Responsible Physician
• Organization: Janssen Research & Development LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 28, 2019
• Study Start: February 8, 2019
• Primary Completion: March 7, 2022
• Study Completion: January 7, 2025
• Last Updated: January 23, 2026
• Results First Posted: May 10, 2023

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (79); FR (11)