A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Study Purpose
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.
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:
- Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug - A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections - Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug - Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug - Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during studyExclusion Criteria:
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has previously received guselkumab or secukinumab - Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers - Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly - Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veinsTrial Details
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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. |
NCT03090100 |
|
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 Research & Development, LLC |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
| Principal Investigator Affiliation | Janssen Research & Development, LLC |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Australia, Canada, Czechia, France, Germany, Hungary, Poland, Spain, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriasis |
| Study Website: | View Trial Website |
The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.
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.
Status
Active, not recruiting
Address
University of Alabama Birmingham
Birmingham, Alabama, 35233
Site Contact
Status
Active, not recruiting
Address
Southern California Permanente Medical Group
Los Angeles, California, 90027
Site Contact
Status
Withdrawn
Address
Quest Dermatology Research
Northridge, California, 91324
Site Contact
Status
Active, not recruiting
Address
Dermatology Specialists
Oceanside, California, 92056
Site Contact
Status
Active, not recruiting
Address
MedDerm Associates
San Diego, California, 92103
Site Contact
Status
Withdrawn
Address
The Regents of the University of California
San Francisco, California, 94118
Site Contact
Status
Active, not recruiting
Address
San Luis Dermatology & Laser Clinic, Inc
San Luis Obispo, California, 93405
Site Contact
Status
Active, not recruiting
Address
Southern California Dermatology
Santa Ana, California, 92701
Site Contact
Status
Active, not recruiting
Address
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810
Site Contact
Status
Active, not recruiting
Address
Olympian Clinical Research
Clearwater, Florida, 33757
Site Contact
Status
Active, not recruiting
Address
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134
Site Contact
Status
Active, not recruiting
Address
Renstar Medical Research
Ocala, Florida, 34470
Site Contact
Status
Active, not recruiting
Address
Park Avenue Dermatology
Orange Park, Florida, 32073
Site Contact
Status
Active, not recruiting
Address
Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, 30022
Site Contact
Status
Active, not recruiting
Address
Advanced Medical Research
Atlanta, Georgia, 30328
Site Contact
Status
Active, not recruiting
Address
Marietta Dermatology Clinical Research
Marietta, Georgia, 30060
Site Contact
Status
Active, not recruiting
Address
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Site Contact
Status
Active, not recruiting
Address
Northshore Universite Healthsystem
Skokie, Illinois, 60077
Site Contact
Status
Active, not recruiting
Address
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Site Contact
Status
Active, not recruiting
Address
Indiana Clinical Trial Center
Plainfield, Indiana, 46168
Site Contact
Status
Active, not recruiting
Address
Dermatology Specialists
Louisville, Kentucky, 40241
Site Contact
Status
Active, not recruiting
Address
Great Lakes Research Group
Bay City, Michigan, 48706
Site Contact
Status
Active, not recruiting
Address
Henry Ford Medical Center
Detroit, Michigan, 49202
Site Contact
Status
Active, not recruiting
Address
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Site Contact
Status
Active, not recruiting
Address
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Site Contact
Status
Active, not recruiting
Address
Central Dermatology
Saint Louis, Missouri, 63117
Site Contact
Status
Active, not recruiting
Address
Windsor Dermatology
East Windsor, New Jersey, 08520-2505
Site Contact
Status
Active, not recruiting
Address
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Site Contact
Status
Withdrawn
Address
Derm Research Center of New York, Inc.
Stony Brook, New York, 11790
Site Contact
Status
Active, not recruiting
Address
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
Site Contact
Status
Active, not recruiting
Address
Dermatologists of Greater Columbus
Bexley, Ohio, 43209
Site Contact
Status
Active, not recruiting
Address
The Ohio State University
Gahanna, Ohio, 43230
Site Contact
Status
Active, not recruiting
Address
Central Sooner Research
Norman, Oklahoma, 73071
Site Contact
Status
Active, not recruiting
Address
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Site Contact
Status
Active, not recruiting
Address
Oregon Medical Research Center
Portland, Oregon, 97223
Site Contact
Status
Active, not recruiting
Address
University of Pittsburgh Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Site Contact
Status
Active, not recruiting
Address
Clinical Partners
Johnston, Rhode Island, 02919
Site Contact
Status
Active, not recruiting
Address
Austin Dermatology Associates
Austin, Texas, 78705
Site Contact
Status
Active, not recruiting
Address
Modern Research Associates
Dallas, Texas, 75231
Site Contact
Status
Active, not recruiting
Address
Menter Dermatology Research Institute
Dallas, Texas, 75246-1615
Site Contact
Status
Active, not recruiting
Address
Suzanne Bruce and Associates - The Center for Skin Research
Houston, Texas, 77056-4132
Site Contact
Status
Active, not recruiting
Address
Progressive Clinical Research
San Antonio, Texas, 78213
Site Contact
Status
Active, not recruiting
Address
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Site Contact
Status
Completed
Address
Virginia Clinical Research
Norfolk, Virginia, 23322
Site Contact
Status
Active, not recruiting
Address
Dermatology Associates of Seattle
Seattle, Washington, 98101-1498
Site Contact
International Sites
Status
Active, not recruiting
Address
Sinclair Dermatology
East Melbourne, , 3002
Site Contact
Status
Active, not recruiting
Address
Fremantle Dermatology
Fremantle, , 6160
Site Contact
Status
Active, not recruiting
Address
Clinical Trials SA Pty Ltd
Hectorville, , 5073
Site Contact
Status
Active, not recruiting
Address
St George Dermatology & Skin Cancer Centre
Kogarah, , 2217
Site Contact
Status
Active, not recruiting
Address
Skin&Cancer Foundation Inc
Melbourne, , 3053
Site Contact
Status
Active, not recruiting
Address
Veracity Clinical Research
Woolloongabba, , 4102
Site Contact
Status
Active, not recruiting
Address
Dermatrials Research
Hamilton, Ontario, L8N 1Y2
Site Contact
Status
Active, not recruiting
Address
Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Site Contact
Status
Active, not recruiting
Address
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Site Contact
Status
Active, not recruiting
Address
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Site Contact
Status
Active, not recruiting
Address
Toronto Research Centre
Toronto, Ontario, M3H5Y8
Site Contact
Status
Active, not recruiting
Address
CCA Medical Research Corporation
Ajax, , L1S7K8
Site Contact
Status
Active, not recruiting
Address
Stratica Medical
Edmonton, , T5K 1X3
Site Contact
Status
Active, not recruiting
Address
Eastern Canada Research Associates
Halifax, , B3H 1Z2
Site Contact
Status
Active, not recruiting
Address
DermEdge Research
Mississauga, , L5H 1G9
Site Contact
Status
Active, not recruiting
Address
Innovaderm Research
Montreal, , H2K4L5
Site Contact
Status
Active, not recruiting
Address
Centre Dermatologique
Quebec, , G1V 4X7
Site Contact
Status
Active, not recruiting
Address
Dr. Chih-ho Hong Medical
Surrey, , V3R 6A7
Site Contact
Status
Active, not recruiting
Address
K. Papp Clinical Research
Waterloo, , N2J 1C4
Site Contact
Status
Active, not recruiting
Address
XLR8 Medical Research
Windsor, , N8W 1E6
Site Contact
Status
Active, not recruiting
Address
Kozni ambulance Kutna Hora, s.r.o.
Kutna Hora, , 248 01
Site Contact
Status
Active, not recruiting
Address
Nemocnice Novy Jicin a.s.
Novy Jicin, , 741 01
Site Contact
Status
Active, not recruiting
Address
Fakultni nemocnice Ostrava
Ostrava- Poruba, , 708 52
Site Contact
Status
Active, not recruiting
Address
Fakultni nemocnice Kralovske Vinohrady
Praha, , 775 20
Site Contact
Status
Active, not recruiting
Address
Dermatologicka ambulance
Svitavy, , 568 02
Site Contact
Status
Active, not recruiting
Address
Masarykova nemocnice v Usti nad Labem
Usti Nad Labem, ,
Site Contact
Status
Completed
Address
CHU Bordeaux - Hopital St Andre
Bordeaux, , 33000
Site Contact
Status
Active, not recruiting
Address
ICH Hopital A. Morvan
Brest, , 29200
Site Contact
Status
Active, not recruiting
Address
Groupe Hospitalier La Rochelle - Re - Aunis
La Rochelle, , 17019
Site Contact
Status
Withdrawn
Address
CHU Marseille - Hopital La Timone
Marseille, , 13385
Site Contact
Status
Active, not recruiting
Address
CHU de Nice Hopital de l Archet
Nice, , 06200
Site Contact
Status
Active, not recruiting
Address
Hopital Charles Nicolle
Rouen, , 76031
Site Contact
Status
Active, not recruiting
Address
Hopital Larrey CHU de Toulouse
Toulouse, , 31000
Site Contact
Status
Active, not recruiting
Address
Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
Berlin, , 10117
Site Contact
Status
Active, not recruiting
Address
Universitatsklinikum Bonn
Bonn, , 53105
Site Contact
Status
Active, not recruiting
Address
Klinische Forschung Dresden GmbH
Dresden, , 01069
Site Contact
Status
Active, not recruiting
Address
University Hospital Dresden
Dresden, , 01307
Site Contact
Status
Active, not recruiting
Address
Universitatsklinikum Essen
Essen, , 45122
Site Contact
Status
Active, not recruiting
Address
Universitatsklinikum Frankfurt
Frankfurt Am Main, , 60590
Site Contact
Status
Active, not recruiting
Address
Universitaetsklinik Hamburg-Eppendorf
Hamburg, , 20246
Site Contact
Status
Active, not recruiting
Address
MensingDerma research GmbH
Hamburg, , 22391
Site Contact
Status
Active, not recruiting
Address
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, , 24105
Site Contact
Status
Active, not recruiting
Address
Universitaetsklinik Luebeck
Luebeck, , 23538
Site Contact
Status
Active, not recruiting
Address
Technische Universitaet Muenchen
Muenchen, , 80802
Site Contact
Status
Active, not recruiting
Address
Universitaetsklinikum Muenster
Muenster, , 48149
Site Contact
Status
Active, not recruiting
Address
Universitaetsklinik Tuebingen
Tuebingen, , 72076
Site Contact
Status
Active, not recruiting
Address
Debreceni Egyetem Klinikai Kozpont
Debrecen, , 4032
Site Contact
Status
Active, not recruiting
Address
Somogy Megyei Kaposi Mor Oktatokorhaz
Kaposvar, , 7400
Site Contact
Status
Active, not recruiting
Address
Bacs-kiskun Megyei Korhaz
Kecskemet, , 6000
Site Contact
Status
Active, not recruiting
Address
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, , 3529
Site Contact
Status
Active, not recruiting
Address
Szegedi Tudomanyegyetem
Szeged, , 6720
Site Contact
Status
Active, not recruiting
Address
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , 9700
Site Contact
Status
Active, not recruiting
Address
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprem, , 8200
Site Contact
Status
Active, not recruiting
Address
NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik
Bialystok, , 15-351
Site Contact
Status
Active, not recruiting
Address
Specderm Poznańska sp. j.
Bialystok, , 15-375
Site Contact
Status
Active, not recruiting
Address
Szpital Uniwersytecki nr 1 im. Dr A. Jurasza
Bydgoszcz, , 85-094
Site Contact
Status
Active, not recruiting
Address
Centrum Kliniczno Badawcze
Elblag, , 82-300
Site Contact
Status
Active, not recruiting
Address
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk, , 80-298
Site Contact
Status
Active, not recruiting
Address
Malopolskie Centrum Medyczne
Krakow, , 30-510
Site Contact
Status
Active, not recruiting
Address
Centrum Badawcze Wspolczesnej Terapii
Lodz, , 90-242
Site Contact
Status
Active, not recruiting
Address
Dermed Centrum Medyczne Sp. z o.o
Lodz, , 90-265
Site Contact
Status
Active, not recruiting
Address
Lubelskie Centrum Diagnostyczne
Swidnik, , 21-040
Site Contact
Status
Active, not recruiting
Address
NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm
Torun, , 87-100
Site Contact
Status
Active, not recruiting
Address
Przychodnia Specjalistyczna High-Med
Warszawa, , 01-817
Site Contact
Status
Active, not recruiting
Address
Wojskowy Instytut Medyczny
Warszawa, , 04-141
Site Contact
Status
Active, not recruiting
Address
DermMedica Sp. z o.o.
Wroclaw, , 51-318
Site Contact
Status
Active, not recruiting
Address
Centrum Medyczne WroMedica
Wroclaw, , 51-685
Site Contact
Status
Active, not recruiting
Address
Hosp. Univ. Fundacion Alcorcon
Alcorcon, , 28922
Site Contact
Status
Active, not recruiting
Address
Hosp. Gral. Univ. de Alicante
Alicante, , 03010
Site Contact
Status
Active, not recruiting
Address
Hosp. Univ. Germans Trias I Pujol
Badalona, , 08916
Site Contact
Status
Active, not recruiting
Address
Hosp. Univ. de Cruces
Barakaldo, , 48903
Site Contact
Status
Active, not recruiting
Address
Hosp. de La Santa Creu I Sant Pau
Barcelona, , 8041
Site Contact
Status
Active, not recruiting
Address
Hosp. Univ. de Basurto
Bilbao Vizcaya, , 48009
Site Contact
Status
Active, not recruiting
Address
Hosp. Univ. Infanta Leonor
Madrid, , 28031
Site Contact
Status
Active, not recruiting
Address
Hosp. Univ. 12 de Octubre
Madrid, , 28041
Site Contact
Status
Active, not recruiting
Address
Hosp. Provincial de Pontevedra
Pontevedra, , 36003
Site Contact
Status
Active, not recruiting
Address
Hosp. Univ. I Politecni La Fe
Valencia, , 046026
Site Contact
