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 |
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.
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
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
Status
Active, not recruiting
Address
Hopital Prive d'Antony
Antony, , 92160
Status
Active, not recruiting
Address
Centre Hospitalier d'Auxerre
Auxerre, , 89011
Status
Active, not recruiting
Address
Polyclinique Reims Bezanne - De Courlancy
Bezanne, , 51430
Status
Active, not recruiting
Address
Centre Hospitalier Le Mans
Le Mans, , 72037
Status
Active, not recruiting
Address
Hôpital Edouard Herriot
Lyon Cedex 03, , 69437
Status
Active, not recruiting
Address
Le Bateau Blanc
Martigues, , 13500
Status
Active, not recruiting
Address
CHU Nantes
Nantes, , 44093
Status
Active, not recruiting
Address
CHU de Nice Hopital de l Archet
Nice, , 06202
Status
Active, not recruiting
Address
CHU Rouen
Rouen, , 76000
Status
Active, not recruiting
Address
HIA se Sainte-Anne - Toulon
Toulon, , 83041
Status
Active, not recruiting
Address
CHU Toulouse
Toulouse, , 31059
Status
Recruiting
Address
Universitätsklinikum Aachen
Aachen, , 52074
Status
Recruiting
Address
Klinikum Augsburg
Augsburg, , 86179
Status
Recruiting
Address
Licca Klinik fuer Operative Medizin
Augsburg, , 86179
Status
Recruiting
Address
Fachklinik Bad Bentheim
Bad Bentheim, , 48455
Status
Recruiting
Address
Hautmedizin Bad Soden
Bad Soden am Taunus, , 65812
Status
Recruiting
Address
Charite CCM, Dermatologie
Berlin, , 10117
Status
Withdrawn
Address
Klinische Forschung Berlin Mitte GmbH
Berlin, , 10117
Status
Recruiting
Address
Vivantes Klinikum Im Friedrichshain
Berlin, , 10119
Status
Withdrawn
Address
Hautzentrum Friedrichshain
Berlin, , 10247
Status
Recruiting
Address
Rothhaar Studien GmbH
Berlin, , 10783
Status
Recruiting
Address
ISA - Interdisciplinary Study Association GmbH
Berlin, , 10789
Status
Recruiting
Address
Hautarztpraxis
Berlin, , 12459
Status
Recruiting
Address
Hautarztpraxis Dr.Wildfeuer
Berlin, , 13055
Status
Completed
Address
Hautarztpraxis
Berlin, , 13597
Status
Recruiting
Address
Praxis 'Haut Pur'
Berlin, , 13597
Status
Recruiting
Address
Klinikum Bielefeld Rosenhoehe
Bielefeld, , 33647
Status
Recruiting
Address
Katholisches Klinikum Bochum gGmbH
Bochum, , 44791
Status
Recruiting
Address
Niesmann & Othlinghaus GbR
Bochum, , 44793
Status
Recruiting
Address
MVZ Dermatologisches Zentrum Bonn GmbH
Bonn, , 53111
Status
Recruiting
Address
Universitatsklinikum Bonn
Bonn, , 53127
Status
Completed
Address
Hautarztpraxis
Borna, , 04552
Status
Recruiting
Address
Hautarztpraxis
Bramsche, , 49565
Status
Recruiting
Address
Klinikum Darmstadt GmbH - Hautklinik
Darmstadt, , 64283
Status
Recruiting
Address
Rosenpark Research GmbH
Darmstadt, , 64283
Status
Completed
Address
Klinische Forschung Dresden GmbH
Dresden, , 01069
Status
Recruiting
Address
Praxis für Dermatologie und Venerologie
Dresden, , 01097
Status
Recruiting
Address
University Hospital Dresden
Dresden, , 01307
Status
Recruiting
Address
Privatpraxis Dr. Hilton & Partner
Düsseldorf, , 40212
Status
Recruiting
Address
Universitätsklinikum Düsseldorf
Düsseldorf, , 40225
Status
Recruiting
Address
Universitaetsklinik Erlangen
Erlangen, , 91054
Status
Recruiting
Address
Universitaetsklinikum Essen
Essen, , 45122
Status
Recruiting
Address
Universitatsklinikum Frankfurt
Frankfurt am Main, , 60590
Status
Recruiting
Address
Universitatsklinikum Freiburg
Freiburg, , 79104
Status
Recruiting
Address
Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen, , 88045
Status
Recruiting
Address
SRH Waldklinikum Gera GmbH
Gera, , 07548
Status
Recruiting
Address
Hautarztpraxis Brau/Groß
Giessen, , 35390
Status
Recruiting
Address
Universitätsmedizin Göttingen
Göttingen, , 37075
Status
Withdrawn
Address
Universitaetsklinikum Halle (Saale)
Halle (Saale), , 06097
Status
Recruiting
Address
Universitaetsklinik Hamburg-Eppendorf
Hamburg, , 20246
Status
Recruiting
Address
Klinische Forschung Hamburg
Hamburg, , 20253
Status
Recruiting
Address
Dermatologikum Hamburg Gmbh
Hamburg, , 20354
Status
Recruiting
Address
SCIderm GmbH
Hamburg, , 20354
Status
Recruiting
Address
MensingDerma research GmbH
Hamburg, , 22391
Status
Recruiting
Address
Die Hautklinik Hanau
Hanau, , 63450
Status
Withdrawn
Address
Medizinische Hochschule Hannover
Hannover, , 30625
Status
Recruiting
Address
Haut- und Laserzentrum Heidelberg
Heidelberg, , 69115
Status
Recruiting
Address
Universitätsklinikum Heidelberg
Heidelberg, , 69120
Status
Recruiting
Address
Hautarztpraxis Offers/Adamini
Ibbenbüren, , 49477
Status
Completed
Address
Universitätsklinikum Jena
Jena, , 07745
Status
Recruiting
Address
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, , 24105
Status
Recruiting
Address
MVZ DermaKiel GmbH
Kiel, , 24148
Status
Recruiting
Address
Universitaetsklinikum Koeln
Koeln, , 50937
Status
Recruiting
Address
Praxis Dr. med. Beate Schwarz - Germany
Langenau, , 89129
Status
Recruiting
Address
Universitätsklinikum Leipzig AÖR
Leipzig, , 04103
Status
Recruiting
Address
Hautarztpraxis
Lingen, , 49809
Status
Withdrawn
Address
Universitaetsklinik Luebeck
Luebeck, , 23538
Status
Withdrawn
Address
Hautarztpraxis Hagemeier
Löhne, , 32584
Status
Withdrawn
Address
Hautarztpraxis
Magdeburg, , 39104
Status
Recruiting
Address
Otto Von Guericke Universität Magdeburg
Magdeburg, , 39120
Status
Recruiting
Address
Gemeinschaftspraxis Scholz/Sebastian/Schilling
Mahlow, , 15831
Status
Recruiting
Address
Hautarztzentrum am MDZ
Mainz, , 55128
Status
Recruiting
Address
Universitaetsmedizin Mainz
Mainz, , 55131
Status
Recruiting
Address
Universitatsklinikum Mannheim
Mannheim, , 68167
Status
Not yet recruiting
Address
UKGM
Marburg, , 35043
Status
Recruiting
Address
Hautarztpraxis
Memmingen, , 87700
Status
Recruiting
Address
Technische Universitaet Muenchen
Muenchen, , 80802
Status
Recruiting
Address
Universitaetsklinikum Muenster
Muenster, , 48149
Status
Recruiting
Address
ZENTderma - Germany
Mönchengladbach, , 41061
Status
Withdrawn
Address
HELIOS St. Elisabeth Klinik Oberhausen
Oberhausen, , 46045
Status
Withdrawn
Address
Hautarztpraxis Greiner
Oberursel, , 61440
Status
Recruiting
Address
Klinikum Oldenburg
Oldenburg, , 26133
Status
Withdrawn
Address
Hautarztpraxis
Osnabrueck, , 49078
Status
Recruiting
Address
Klinische Forschung Osnabrück
Osnabrück, , 49074
Status
Recruiting
Address
Hautarztpraxis
Potsdam, , 14467
Status
Completed
Address
Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay
Quedlinburg, , 06484
Status
Completed
Address
Universitaetsklinikum Regensburg
Regensburg, , 93053
Status
Recruiting
Address
Hautarztpraxis Mortazawi
Remscheid, , 42897
Status
Recruiting
Address
Klinische Forschung Schwerin GmbH
Schwerin, , 19055
Status
Recruiting
Address
Company for Medical Study & Service Selters
Selters, , 56242
Status
Recruiting
Address
Hautarztpraxis Dr. Leitz & Kollegen
Stuttgart, , 70178
Status
Recruiting
Address
Hautarztpraxis am Loewenmarkt
Stuttgart, , 70499
Status
Recruiting
Address
Universitätsklinikum Tübingen
Tübingen, , 72076
Status
Recruiting
Address
Universitätsklinikum Ulm
Ulm, , 89081
Status
Recruiting
Address
Hautarztpraxis Kock
Vechta, , 49377
Status
Recruiting
Address
HELIOS Klinikum Wuppertal GmbH
Wuppertal, , 42283
Status
Recruiting
Address
CentroDerm GmbH
Wuppertal, , 42287
Status
Recruiting
Address
Universitätsklinikum Würzburg
Würzburg, , 97080