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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 percent (%) 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 (e.g.) methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus), 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03818035
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen-Cilag G.m.b.H
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen-Cilag G.m.b.H, Germany Clinical Trial
Principal Investigator Affiliation Janssen-Cilag G.m.b.H
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Part 1: Guselkumab

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

Experimental: 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.

Experimental: 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.

Experimental: 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 116 (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.

Interventions

Drug: - 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, 2c, 2d and 3c), 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.

Drug: - Placebo Injection

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hopital Prive d'Antony, Antony, France

Status

Recruiting

Address

Hopital Prive d'Antony

Antony, , 92160

Centre Hospitalier d'Auxerre, Auxerre, France

Status

Recruiting

Address

Centre Hospitalier d'Auxerre

Auxerre, , 89011

Bezanne, France

Status

Recruiting

Address

Polyclinique Reims Bezanne - De Courlancy

Bezanne, , 51430

Centre Hospitalier Le Mans, Le Mans, France

Status

Recruiting

Address

Centre Hospitalier Le Mans

Le Mans, , 72037

Hôpital Edouard Herriot, Lyon Cedex 03, France

Status

Recruiting

Address

Hôpital Edouard Herriot

Lyon Cedex 03, , 69437

Le Bateau Blanc, Martigues, France

Status

Recruiting

Address

Le Bateau Blanc

Martigues, , 13500

CHU Nantes, Nantes, France

Status

Recruiting

Address

CHU Nantes

Nantes, , 44093

CHU de Nice Hopital de l Archet, Nice, France

Status

Recruiting

Address

CHU de Nice Hopital de l Archet

Nice, , 06202

CHU Rouen, Rouen, France

Status

Recruiting

Address

CHU Rouen

Rouen, , 76000

HIA se Sainte-Anne - Toulon, Toulon, France

Status

Recruiting

Address

HIA se Sainte-Anne - Toulon

Toulon, , 83041

CHU Toulouse, Toulouse, France

Status

Recruiting

Address

CHU Toulouse

Toulouse, , 31059

Universitätsklinikum Aachen, Aachen, Germany

Status

Recruiting

Address

Universitätsklinikum Aachen

Aachen, , 52074

Klinikum Augsburg, Augsburg, Germany

Status

Recruiting

Address

Klinikum Augsburg

Augsburg, , 86179

Licca Klinik fuer Operative Medizin, Augsburg, Germany

Status

Recruiting

Address

Licca Klinik fuer Operative Medizin

Augsburg, , 86179

Fachklinik Bad Bentheim, Bad Bentheim, Germany

Status

Recruiting

Address

Fachklinik Bad Bentheim

Bad Bentheim, , 48455

Hautmedizin Bad Soden, Bad Soden am Taunus, Germany

Status

Recruiting

Address

Hautmedizin Bad Soden

Bad Soden am Taunus, , 65812

Charite CCM, Dermatologie, Berlin, Germany

Status

Recruiting

Address

Charite CCM, Dermatologie

Berlin, , 10117

Klinische Forschung Berlin Mitte GmbH, Berlin, Germany

Status

Withdrawn

Address

Klinische Forschung Berlin Mitte GmbH

Berlin, , 10117

Vivantes Klinikum Im Friedrichshain, Berlin, Germany

Status

Recruiting

Address

Vivantes Klinikum Im Friedrichshain

Berlin, , 10119

Hautzentrum Friedrichshain, Berlin, Germany

Status

Withdrawn

Address

Hautzentrum Friedrichshain

Berlin, , 10247

Rothhaar Studien GmbH, Berlin, Germany

Status

Recruiting

Address

Rothhaar Studien GmbH

Berlin, , 10783

Berlin, Germany

Status

Recruiting

Address

ISA - Interdisciplinary Study Association GmbH

Berlin, , 10789

Hautarztpraxis, Berlin, Germany

Status

Recruiting

Address

Hautarztpraxis

Berlin, , 12459

Hautarztpraxis Dr.Wildfeuer, Berlin, Germany

Status

Recruiting

Address

Hautarztpraxis Dr.Wildfeuer

Berlin, , 13055

Hautarztpraxis, Berlin, Germany

Status

Completed

Address

Hautarztpraxis

Berlin, , 13597

Praxis 'Haut Pur', Berlin, Germany

Status

Recruiting

Address

Praxis 'Haut Pur'

Berlin, , 13597

Klinikum Bielefeld Rosenhoehe, Bielefeld, Germany

Status

Recruiting

Address

Klinikum Bielefeld Rosenhoehe

Bielefeld, , 33647

Katholisches Klinikum Bochum gGmbH, Bochum, Germany

Status

Recruiting

Address

Katholisches Klinikum Bochum gGmbH

Bochum, , 44791

Niesmann & Othlinghaus GbR, Bochum, Germany

Status

Recruiting

Address

Niesmann & Othlinghaus GbR

Bochum, , 44793

MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany

Status

Recruiting

Address

MVZ Dermatologisches Zentrum Bonn GmbH

Bonn, , 53111

Universitatsklinikum Bonn, Bonn, Germany

Status

Recruiting

Address

Universitatsklinikum Bonn

Bonn, , 53127

Hautarztpraxis, Borna, Germany

Status

Recruiting

Address

Hautarztpraxis

Borna, , 04552

Hautarztpraxis, Bramsche, Germany

Status

Recruiting

Address

Hautarztpraxis

Bramsche, , 49565

Derma Nord, Bremen, Germany

Status

Recruiting

Address

Derma Nord

Bremen, , 28779

Rosenpark Research GmbH, Darmstadt, Germany

Status

Recruiting

Address

Rosenpark Research GmbH

Darmstadt, , 64283

Klinikum Darmstadt GmbH - Hautklinik, Darmstadt, Germany

Status

Recruiting

Address

Klinikum Darmstadt GmbH - Hautklinik

Darmstadt, , 64297

Klinische Forschung Dresden GmbH, Dresden, Germany

Status

Recruiting

Address

Klinische Forschung Dresden GmbH

Dresden, , 01069

Praxis für Dermatologie und Venerologie, Dresden, Germany

Status

Recruiting

Address

Praxis für Dermatologie und Venerologie

Dresden, , 01097

University Hospital Dresden, Dresden, Germany

Status

Recruiting

Address

University Hospital Dresden

Dresden, , 01307

Pro Derma, Duelmen, Germany

Status

Recruiting

Address

Pro Derma

Duelmen, , 48249

Privatpraxis Dr. Hilton & Partner, Düsseldorf, Germany

Status

Recruiting

Address

Privatpraxis Dr. Hilton & Partner

Düsseldorf, , 40212

Universitätsklinikum Düsseldorf, Düsseldorf, Germany

Status

Recruiting

Address

Universitätsklinikum Düsseldorf

Düsseldorf, , 40225

Universitaetsklinik Erlangen, Erlangen, Germany

Status

Recruiting

Address

Universitaetsklinik Erlangen

Erlangen, , 91054

Universitaetsklinikum Essen, Essen, Germany

Status

Recruiting

Address

Universitaetsklinikum Essen

Essen, , 45122

Universitatsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt am Main, , 60590

Universitatsklinikum Freiburg, Freiburg, Germany

Status

Recruiting

Address

Universitatsklinikum Freiburg

Freiburg, , 79104

Derma-Study-Center Friedrichshafen GmbH, Friedrichshafen, Germany

Status

Recruiting

Address

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, , 88045

SRH Waldklinikum Gera GmbH, Gera, Germany

Status

Recruiting

Address

SRH Waldklinikum Gera GmbH

Gera, , 07548

Hautarztpraxis Brau/Groß, Giessen, Germany

Status

Recruiting

Address

Hautarztpraxis Brau/Groß

Giessen, , 35390

Universitätsmedizin Göttingen, Göttingen, Germany

Status

Recruiting

Address

Universitätsmedizin Göttingen

Göttingen, , 37075

Universitaetsklinikum Halle (Saale), Halle (Saale), Germany

Status

Withdrawn

Address

Universitaetsklinikum Halle (Saale)

Halle (Saale), , 06097

Universitaetsklinik Hamburg-Eppendorf, Hamburg, Germany

Status

Recruiting

Address

Universitaetsklinik Hamburg-Eppendorf

Hamburg, , 20246

Klinische Forschung Hamburg, Hamburg, Germany

Status

Recruiting

Address

Klinische Forschung Hamburg

Hamburg, , 20253

Dermatologikum Hamburg Gmbh, Hamburg, Germany

Status

Recruiting

Address

Dermatologikum Hamburg Gmbh

Hamburg, , 20354

SCIderm GmbH, Hamburg, Germany

Status

Recruiting

Address

SCIderm GmbH

Hamburg, , 20354

MensingDerma research GmbH, Hamburg, Germany

Status

Recruiting

Address

MensingDerma research GmbH

Hamburg, , 22391

Die Hautklinik Hanau, Hanau, Germany

Status

Recruiting

Address

Die Hautklinik Hanau

Hanau, , 63450

Medizinische Hochschule Hannover, Hannover, Germany

Status

Withdrawn

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Haut- und Laserzentrum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Haut- und Laserzentrum Heidelberg

Heidelberg, , 69115

Universitätsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitätsklinikum Heidelberg

Heidelberg, , 69120

Hautarztpraxis Offers/Adamini, Ibbenbüren, Germany

Status

Recruiting

Address

Hautarztpraxis Offers/Adamini

Ibbenbüren, , 49477

Universitätsklinikum Jena, Jena, Germany

Status

Completed

Address

Universitätsklinikum Jena

Jena, , 07745

Kiel, Germany

Status

Recruiting

Address

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , 24105

MVZ DermaKiel GmbH, Kiel, Germany

Status

Recruiting

Address

MVZ DermaKiel GmbH

Kiel, , 24148

Universitaetsklinikum Koeln, Koeln, Germany

Status

Recruiting

Address

Universitaetsklinikum Koeln

Koeln, , 50937

Praxis Dr. med. Beate Schwarz - Germany, Langenau, Germany

Status

Recruiting

Address

Praxis Dr. med. Beate Schwarz - Germany

Langenau, , 89129

Universitätsklinikum Leipzig AÖR, Leipzig, Germany

Status

Recruiting

Address

Universitätsklinikum Leipzig AÖR

Leipzig, , 04103

Hautarztpraxis, Lingen, Germany

Status

Recruiting

Address

Hautarztpraxis

Lingen, , 49809

Universitaetsklinik Luebeck, Luebeck, Germany

Status

Withdrawn

Address

Universitaetsklinik Luebeck

Luebeck, , 23538

Hautarztpraxis Hagemeier, Löhne, Germany

Status

Withdrawn

Address

Hautarztpraxis Hagemeier

Löhne, , 32584

Hautarztpraxis, Magdeburg, Germany

Status

Withdrawn

Address

Hautarztpraxis

Magdeburg, , 39104

Otto Von Guericke Universität Magdeburg, Magdeburg, Germany

Status

Recruiting

Address

Otto Von Guericke Universität Magdeburg

Magdeburg, , 39120

Mahlow, Germany

Status

Recruiting

Address

Gemeinschaftspraxis Scholz/Sebastian/Schilling

Mahlow, , 15831

Hautarztzentrum am MDZ, Mainz, Germany

Status

Recruiting

Address

Hautarztzentrum am MDZ

Mainz, , 55128

Universitaetsmedizin Mainz, Mainz, Germany

Status

Recruiting

Address

Universitaetsmedizin Mainz

Mainz, , 55131

Universitatsklinikum Mannheim, Mannheim, Germany

Status

Recruiting

Address

Universitatsklinikum Mannheim

Mannheim, , 68167

UKGM, Marburg, Germany

Status

Not yet recruiting

Address

UKGM

Marburg, , 35043

Hautarztpraxis, Memmingen, Germany

Status

Recruiting

Address

Hautarztpraxis

Memmingen, , 87700

Technische Universitaet Muenchen, Muenchen, Germany

Status

Recruiting

Address

Technische Universitaet Muenchen

Muenchen, , 80802

Universitaetsklinikum Muenster, Muenster, Germany

Status

Recruiting

Address

Universitaetsklinikum Muenster

Muenster, , 48149

ZENTderma - Germany, Mönchengladbach, Germany

Status

Recruiting

Address

ZENTderma - Germany

Mönchengladbach, , 41061

HELIOS St. Elisabeth Klinik Oberhausen, Oberhausen, Germany

Status

Withdrawn

Address

HELIOS St. Elisabeth Klinik Oberhausen

Oberhausen, , 46045

Hautarztpraxis Greiner, Oberursel, Germany

Status

Withdrawn

Address

Hautarztpraxis Greiner

Oberursel, , 61440

Klinikum Oldenburg, Oldenburg, Germany

Status

Recruiting

Address

Klinikum Oldenburg

Oldenburg, , 26133

Hautarztpraxis, Osnabrueck, Germany

Status

Withdrawn

Address

Hautarztpraxis

Osnabrueck, , 49078

Klinische Forschung Osnabrück, Osnabrück, Germany

Status

Recruiting

Address

Klinische Forschung Osnabrück

Osnabrück, , 49074

Hautarztpraxis, Potsdam, Germany

Status

Recruiting

Address

Hautarztpraxis

Potsdam, , 14467

Quedlinburg, Germany

Status

Completed

Address

Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay

Quedlinburg, , 06484

Universitaetsklinikum Regensburg, Regensburg, Germany

Status

Completed

Address

Universitaetsklinikum Regensburg

Regensburg, , 93053

Hautarztpraxis Mortazawi, Remscheid, Germany

Status

Recruiting

Address

Hautarztpraxis Mortazawi

Remscheid, , 42897

Klinische Forschung Schwerin GmbH, Schwerin, Germany

Status

Recruiting

Address

Klinische Forschung Schwerin GmbH

Schwerin, , 19055

Selters, Germany

Status

Recruiting

Address

Company for Medical Study & Service Selters

Selters, , 56242

Hautarztpraxis Dr. Leitz & Kollegen, Stuttgart, Germany

Status

Recruiting

Address

Hautarztpraxis Dr. Leitz & Kollegen

Stuttgart, , 70178

Hautarztpraxis am Loewenmarkt, Stuttgart, Germany

Status

Recruiting

Address

Hautarztpraxis am Loewenmarkt

Stuttgart, , 70499

Universitätsklinikum Tübingen, Tübingen, Germany

Status

Recruiting

Address

Universitätsklinikum Tübingen

Tübingen, , 72076

Universitätsklinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Universitätsklinikum Ulm

Ulm, , 89081

Hautarztpraxis Kock, Vechta, Germany

Status

Recruiting

Address

Hautarztpraxis Kock

Vechta, , 49377

Centrovital, Witten, Germany

Status

Recruiting

Address

Centrovital

Witten, , 58453

HELIOS Klinikum Wuppertal GmbH, Wuppertal, Germany

Status

Recruiting

Address

HELIOS Klinikum Wuppertal GmbH

Wuppertal, , 42283

CentroDerm GmbH, Wuppertal, Germany

Status

Recruiting

Address

CentroDerm GmbH

Wuppertal, , 42287

Universitätsklinikum Würzburg, Würzburg, Germany

Status

Recruiting

Address

Universitätsklinikum Würzburg

Würzburg, , 97080

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