Phase
Condition
Rosacea
Warts
Rash
Treatment
Ustekinumab
ABP 654
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Stable moderate to severe plaque psoriasis for at least 6 months
Baseline score of PASI >= 12, involvement of >= 10% BSA, and sPGA >= 3 at screeningand at baseline
Candidate for phototherapy or systemic therapy
Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Female participants should have negative serum pregnancy test during screening and anegative urine pregnancy test at baseline
No known history of latent or active tuberculosis (TB), and has a negative test forTB during screening (with negative purified protein derivative (PPD), and NegativeQuantiferon®/T-spot test)
Participants with a positive purified protein derivative and a history of BacillusCalmette-Guérin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®
Participants with a positive PPD test (without history of BCG vaccination) orparticipants with a positive or indeterminate Quantiferon®/T-spot test are allowedif they have all of the following:
No symptoms per TB worksheet provided by the sponsor
Documented history of adequate prophylaxis initiation prior to receivinginvestigational product (IP) in accordance with local recommendations
No known exposure to a case of active TB after most recent prophylaxis
No evidence of active TB on chest radiograph within 3 months prior to the firstdose of IP
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Skin disease related conditions such as, Erythrodermic psoriasis (PsO), pustularPsO, guttate PsO, medication induced PsO, or other skin conditions at the time ofthe screening visit (eg, eczema) that would interfere with evaluations of the effectof IP on PsO
Participant has an active infection, recurrent or chronic infections, seriousinfection or history of infections
Known history of human immunodeficiency virus
Hepatitis B surface antigen or hepatitis C virus antibody positivity at screening
Uncontrolled, clinically significant systemic disease such as uncontrolled diabetesmellitus, cardiovascular disease, renal disease, liver disease, or hypertension
Moderate to severe heart failure (New York Heart Associate class III/IV)
Known hypersensitivity to the IP or to any of the excipients
Any abnormal laboratory parameters at screening, as defined in protocol
Previous treatment with any agent specifically targeting interleukin (IL)-12 orIL-23
Received biologic treatment for psoriasis within the previous month or 5 drughalf-lives prior to randomization
Received non-biologic systemic psoriasis therapy within 4 weeks prior torandomization
Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimerlaser within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapywithin 2 weeks prior to randomization
Received topical psoriasis treatment within 2 weeks prior to randomization (exception: upper mid-strength to least potent [class III to VII] topical steroidspermitted on the palms, soles, face, and intertriginous areas; bland emollients)
Received live viral or live bacterial vaccination within 2 weeks prior torandomization
Received BCG vaccination within 1 year prior to randomization
Other investigational procedures within 4 weeks prior to randomization and duringthe study
Participants not agreeing to follow protocol defined contraceptives procedures
Participants likely not to be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures
Study Design
Study Description
Connect with a study center
Beacon Dermatology
Calgary, Alberta T3E 0B2
CanadaSite Not Available
Research Site
Edmonton, Alberta T5K 1X3
CanadaSite Not Available
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
CCA Medical Research
Ajax, Ontario L1S 7K8
CanadaSite Not Available
Kingsway Clinical Research
Etobicoke, Ontario M8X 1Y9
CanadaSite Not Available
Dermatrials Research Inc
Hamilton, Ontario L8N1Y2
CanadaSite Not Available
Lynderm Research Inc
Markham, Ontario L3P 1X3
CanadaSite Not Available
DermEdge Research Inc.
Mississauga, Ontario L4Y 4C5
CanadaSite Not Available
North Bay Dermatology Centre Inc.
North Bay, Ontario P1B 3Z7
CanadaSite Not Available
JRB Research Inc.
Ottawa, Ontario K1H 7X3
CanadaSite Not Available
Skin Centre for Dermatology
Peterborough, Ontario K9J 5K2
CanadaSite Not Available
The Centre for Dermatology
Richmond Hill, Ontario L4B 1A5
CanadaSite Not Available
Toronto Research Centre - Dermatology
Toronto, Ontario M3H 5Y8
CanadaSite Not Available
K. Papp Clinical Research Inc.
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
XLR8 Medical Research Inc.
Windsor, Ontario N8W 1E6
CanadaSite Not Available
Centre de Recherche dermatolog
Quebec city, Quebec G1V 4X7
CanadaSite Not Available
Confido Private Medical Clinic - General Practice/Medicine
Tallinn, Harjumaa 10138
EstoniaSite Not Available
Vahlberg & Pild OÜ
Tallinn, Harjumaa 10134
EstoniaSite Not Available
Clinical Research Center
Tartu, Tartumaa 50106
EstoniaSite Not Available
Tartu University Hospital
Tartu, Tartumaa 50417
EstoniaSite Not Available
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow, Brandenburg 15831
GermanySite Not Available
Derma Zentrum Osnabrueck Nord
Bramsche, Niedersachsen 49565
GermanySite Not Available
Hautzentrum im Jahrhunderthaus
Bochum, Nordrhein-Westfalen 44793
GermanySite Not Available
CentroDerm GmbH
Wuppertal, Nordrhein-Westfalen 42287
GermanySite Not Available
Brgyógyászati és Allergológiai Magánrendelés
Szolnok, Jász-Nagykun-Szolnok 5000
HungarySite Not Available
UNOMEDICALTRIALS Kft
Budapest, Pest 1152
HungarySite Not Available
Health Centre 4 Ltd., Diagnostics Centre
Riga, Rga LV-1003
LatviaSite Not Available
J.Kisis LtD
Riga, Rga LV1003
LatviaSite Not Available
Riga 1st hospital, Clinic of Dermatology and STD
Riga, Rga LV1001
LatviaSite Not Available
Health and Aesthetics Ltd
Riga, LV-1009
LatviaSite Not Available
Smite Aija doctor practice in dermatology, venereology
Talsi, LV3201
LatviaSite Not Available
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
Kaunas, Kauno Apskritis LT-50161
LithuaniaSite Not Available
Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras
Vilnius, Vilniaus Apskritis LT-08411
LithuaniaSite Not Available
Centrum Medyczne Pratia Katowice
Tychy, Lskie 43-100
PolandSite Not Available
Centrum Medyczne ALL-MED
Krakow, Maopolskie 30-033
PolandSite Not Available
ETG Warszawa
Warszawa, Mazowieckie 02-793
PolandSite Not Available
Medycyna Kliniczna
Warszawa, Mazowieckie 00-874
PolandSite Not Available
Royalderm Agnieszka Nawrocka
Warszawa, Mazowieckie 02-962
PolandSite Not Available
Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.
Iwonicz Zdroj, Podkarpackie 38-440
PolandSite Not Available
ClinicMed Daniluk, Nowak Sp. J.
Bialystok, Podlaskie 15-879
PolandSite Not Available
Specderm Poznanska Sp. j.
Bialystok, Podlaskie 15-017
PolandSite Not Available
ETG Skierniewice
Skierniewice, Ódzkie 96-100
PolandSite Not Available
Centrum Medyczne Angelius Provita
Katowice, 40-611
PolandSite Not Available
Centrum Medyczne Pratia Katowice
Katowice, 40-081
PolandSite Not Available
Barbara Rewerska Diamond Clinic
Krakow, 31-559
PolandSite Not Available
Centrum Zdrowia i Urody Maxxmed
Lublin, 20-080
PolandSite Not Available
ETG Lublin
Lublin, 20-412
PolandSite Not Available
Solumed
Poznan, 60-529
PolandSite Not Available
Nasz Lekarz Osrodek Badan Klinicznych
Torun, 87-100
PolandSite Not Available
Klinika Ambroziak Dermatologia
Warszawa, 02-953
PolandSite Not Available
DermMedica Sp. z o.o.
Wroclaw, 51-318
PolandSite Not Available
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, 51-685
PolandSite Not Available
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama 35205
United StatesSite Not Available
Alliance Dermatology and Mohs Center
Phoenix, Arizona 85032
United StatesSite Not Available
First OC Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
University Clinical Trials, Inc.
San Diego, California 92123
United StatesSite Not Available
San Luis Dermatology and Laser Clinic - Dermatology
San Luis Obispo, California 93405
United StatesSite Not Available
Clinical Science Institute
Santa Monica, California 90404
United StatesSite Not Available
Unison Clinical Trials
Sherman Oaks, California 91403
United StatesSite Not Available
Revival Research
Doral, Florida 33122
United StatesSite Not Available
International Dermatology Research, Inc
Miami, Florida 33144
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34470
United StatesSite Not Available
Moore Clinical Research Inc.
Tampa, Florida 33609-2230
United StatesSite Not Available
NorthShore University HealthSystem
Skokie, Illinois 60077
United StatesSite Not Available
Springfield Clinic
Springfield, Illinois 62703-2403
United StatesSite Not Available
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250-2041
United StatesSite Not Available
Research Site
West Des Moines, Iowa 50265
United StatesSite Not Available
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas 66210
United StatesSite Not Available
DelRicht Research
Baton Rouge, Louisiana 70809
United StatesSite Not Available
ALLCUTIS Research, LLC.
Beverly, Massachusetts 01915
United StatesSite Not Available
Metro Boston Clinical Partners
Brighton, Massachusetts 02135
United StatesSite Not Available
Research Site
Warren, Michigan 48088
United StatesSite Not Available
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey 08520
United StatesSite Not Available
Dermatology Consulting Services, PLLC
High Point, North Carolina 27262
United StatesSite Not Available
Wilmington Dermatology Center
Wilmington, North Carolina 28405
United StatesSite Not Available
Bexley Dermatology Research
Bexley, Ohio 43209-2421
United StatesSite Not Available
Dermatologists of Southwest Ohio
Mason, Ohio 45040
United StatesSite Not Available
Oregon Dermatology and Research Center
Portland, Oregon 97210
United StatesSite Not Available
Oregon Medical Research Center
Portland, Oregon 97223
United StatesSite Not Available
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania 19341
United StatesSite Not Available
Clinical Partners, LLC
Johnston, Rhode Island 02919
United StatesSite Not Available
The Skin Wellness Center PC
Knoxville, Tennessee 37922
United StatesSite Not Available
Center for Clinical Studies
Cypress, Texas 77433
United StatesSite Not Available
Modern Research Associates
Dallas, Texas 75231
United StatesSite Not Available
Austin Institute for Clinical Research - Dermatology
Houston, Texas 77056
United StatesSite Not Available
Progressive Clinical Research [Texas]
San Antonio, Texas 78213
United StatesSite Not Available
Acclaim Dermatology
Sugar Land, Texas 77479-2645
United StatesSite Not Available
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