Phase
Condition
Skin Wounds
Warts
Scalp Disorders
Treatment
Ustekinumab
ABP 654
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant has stable moderate to severe plaque psoriasis for at least 6 months
- Participant has a score of PASI ≥ 12, involvement of ≥ 10% body surface area andstatic Physician Global Assessment ≥ 3 at screening and at baseline
- Participant is a candidate for phototherapy or systemic therapy
- Participant has previous failure, inadequate response, intolerance, orcontraindication to at least 1 conventional antipsoriatic systemic therapy
- Female participant should have a negative serum pregnancy test during screening and anegative urine pregnancy test at baseline
- Participant or legally acceptable representative is capable of giving signedInstitutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent
- Participant has no known history of latent or active tuberculosis
- Participant with a positive purified protein derivative (PPD) test and a history ofBacillus Calmette-Guérin (BCG) vaccination is allowed with a negativeQuantiferon/T-spot test
- Participant with a positive PPD test or participant with a positive or indeterminateQuantiferon/T-spot test is allowed if he/she has all the following:
- No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc.
- Documented history of adequate prophylaxis initiation prior to receivinginvestigational product in accordance with local recommendations
- No known exposure to a case of active tuberculosis after most recent prophylaxis
- No evidence of active tuberculosis on chest radiograph within 3 months prior tothe first dose of investigational product
Exclusion
Exclusion Criteria:
- Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,medication induced psoriasis, or other skin conditions at the time of screening (eg,eczema) that would interfere with evaluations of the effect of investigational productof psoriasis
- Participant has an active infection or history of infections
- Participant has uncontrolled, clinically significant systemic disease, such asuncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease,or hypertension
- Participant has a mean QT internal or abnormal long QT syndrome corrected usingFridericia's formula (QTcF) of > 450 msec (for male participant) or > 470 msec (forfemale participant) at baseline that, in the opinion of the Investigator, is abnormalor clinically significant
- Participant has moderate to severe heart failure (New York Heart Associate classIII/IV)
- Participant has known hypersensitivity to the investigational product or to any of theexcipients
- Participant has laboratory abnormalities at screening
- Participant has had previous treatment with any agent specifically targetinginterleukin (IL)-12 or IL-23 within 1 year prior to enrollment
- Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
- Participant has received any investigational agents within the previous month or 5half-lives (whichever is longer) prior to enrollment
- Participant has received non-biologic systemic psoriasis therapy within 4 weeks priorto enrollment
- Participant has received ultraviolet A phototherapy (with or without psoralen) orexcimer laser within 4 weeks prior to enrollment, or ultraviolet B phototherapy within 2 weeks prior to enrollment
- Participant has received topical psoriasis treatment within 2 weeks prior toenrollment
- Participant has received other investigational procedures within 4 weeks prior toenrollment and during the course of the study
- Female participant is pregnant or breastfeeding or planning to become pregnant whileparticipating in the study and for at least 5 months after the last dose ofinvestigational product
- Sexually active participants and their partners who are of childbearing potential andnot agreeing to use adequate protocol defined contraception methods whileparticipating in the study and for 5 months after the last dose of investigationalproduct
Study Design
Study Description
Connect with a study center
Dermatology Research Institute
Calgary, Alberta T2J 7E1
CanadaSite Not Available
Enverus Medical Research
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick E3B 1G9
CanadaSite Not Available
CCA Medical Research
Ajax, Ontario L1S 7K8
CanadaSite Not Available
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario L4M 7G1
CanadaSite Not Available
Guelph Dermatology Research
Guelph, Ontario N1L 0B7
CanadaSite Not Available
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario N6H 5L5
CanadaSite Not Available
Lynderm Research Inc
Markham, Ontario L3P 1X3
CanadaSite Not Available
DermEdge Research Inc.
Mississauga, Ontario L4Y 4C5
CanadaSite Not Available
Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office
Newmarket, Ontario L3Y 5G8
CanadaSite Not Available
North York Research Inc. - Dermatology
North York, Ontario M2M 4J5
CanadaSite Not Available
Dermatology Ottawa Research Centre
Ottawa, Ontario K2C 3N2
CanadaSite Not Available
Research Toronto
Toronto, Ontario M4W 2N4
CanadaSite Not Available
K. Papp Clinical Research Inc.
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
Skinsense Medical Research
Saskatoon, Saskatchewan S7K 0H6
CanadaSite Not Available
Confido Private Medical Clinic - General Practice/Medicine
Tallinn, Harjumaa 10138
EstoniaSite Not Available
Clinical Research Center
Tartu, Tartumaa 50106
EstoniaSite Not Available
Tartu University Hospital
Tartu, Tartumaa 50417
EstoniaSite Not Available
Innomedica OÜ
Tallinn, 10117
EstoniaSite Not Available
,,Tbilisi Cancer center"LTD
Tbilisi, T'bilisi 0159
GeorgiaSite Not Available
Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
Tbilisi, T'bilisi 0112
GeorgiaSite Not Available
LTD Aversi Clinic
Tbilisi, T'bilisi 0160
GeorgiaSite Not Available
LTD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, T'bilisi 0112
GeorgiaSite Not Available
,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC
Tbilisi, 0159
GeorgiaSite Not Available
Derma-Study-Center-FN
Friedrichshafen, Baden-Württemberg 88045
GermanySite Not Available
Dermazentrum Augsburg
Augsburg, Bayern 86179
GermanySite Not Available
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow, Brandenburg 15831
GermanySite Not Available
Universitätsklinikum Frankfurt am Main - Klinik für Dermatol
Frankfurt/Main, Hessen 60590
GermanySite Not Available
Fachklinik Bad Bentheim
Bad Bentheim, Niedersachsen 48455
GermanySite Not Available
Praxis Hoffmann
Witten, Nordrhein-Westfalen 58453
GermanySite Not Available
Klinische Forschung Dresden GmbH
Dresden, Sachsen 01069
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen 01307
GermanySite Not Available
UK-SH - Lübeck
Lübeck, Schleswig-Holstein 23538
GermanySite Not Available
Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
Berlin, 10117
GermanySite Not Available
Rothhaar Studien GmbH
Berlin, 10783
GermanySite Not Available
Debreceni Egyetem Klinikai Központ Nagyerdei Campus
Debrecen, Hajdú-Bihar 4032
HungarySite Not Available
Brgyógyászati és Allergológiai Magánrendelés
Szolnok, Jász-Nagykun-Szolnok 5000
HungarySite Not Available
Qualiclinic Kft
Budapest, Pest 1036
HungarySite Not Available
UNOMEDICALTRIALS Kft
Budapest, Pest 1152
HungarySite 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
Smite Aija doctor practice in dermatology, venereology
Talsi, LV3201
LatviaSite Not Available
Centrum Medyczne ALL-MED Badania Kliniczne
Krakow, Maopolskie 30-033
PolandSite Not Available
Centrum Medyczne Plejady
Krakow, Maopolskie 30-363
PolandSite Not Available
MICS Centrum Medyczne Warszawa
Warszawa, Mazowieckie 00-874
PolandSite Not Available
RENEW CLINIC Spolka Jawna
Bialystok, 15-794
PolandSite Not Available
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796
PolandSite Not Available
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
PolandSite Not Available
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
PolandSite Not Available
Barbara Rewerska Diamond Clinic
Krakow, 31-559
PolandSite Not Available
Centrum Medyczne PROMED
Krakow, 31-513
PolandSite Not Available
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501
PolandSite Not Available
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sol, 67-100
PolandSite Not Available
ETG Siedlce
Siedlce, 08-110
PolandSite Not Available
RCMed Oddzial Sochaczew
Sochaczew, 96-500
PolandSite Not Available
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
PolandSite Not Available
Centrum Medyczne Evimed
Warszawa, 02-625
PolandSite Not Available
RCMed Oddzia Warszawa
Warszawa, 00-892
PolandSite Not Available
DermMedica Sp. z o.o.
Wroclaw, 51-318
PolandSite Not Available
Hospital Universitario Reina Sofia
Córdoba, Andalucía 14004
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Burke Pharmaceutical Research
Hot Springs, Arkansas 71913
United StatesSite Not Available
Zenith Research Inc.
Beverly Hills, California 90212
United StatesSite Not Available
Center for Dermatology Clinical Research, Inc.
Fremont, California 94538
United StatesSite Not Available
Quest Dermatology Research
Northridge, California 91324-4669
United StatesSite Not Available
Southern California Dermatology, Inc
Santa Ana, California 92701
United StatesSite Not Available
Clearlyderm Dermatology
Boca Raton, Florida 33428
United StatesSite Not Available
Encore Research Group-Jacksonville Center for Clinical Resea
Jacksonville, Florida 32216
United StatesSite Not Available
Altus Research, Inc.
Lake Worth, Florida 33461
United StatesSite Not Available
International Dermatology Research, Inc.
Miami, Florida 33144
United StatesSite Not Available
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida 32174
United StatesSite Not Available
Research Site
Palm Beach, Florida 33461
United StatesSite Not Available
Altus Research, Inc.
Palm Springs, Florida 33461
United StatesSite Not Available
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida 33028-1013
United StatesSite Not Available
Olympian Clinical Research
Tampa, Florida 33614
United StatesSite Not Available
Hamilton Research, LLC
Alpharetta, Georgia 30022
United StatesSite Not Available
Advanced Medical Research PC
Sandy Springs, Georgia 30328
United StatesSite Not Available
Dundee Dermatology
West Dundee, Illinois 60118
United StatesSite Not Available
DS Research
Clarksville, Indiana 47129
United StatesSite Not Available
DS Research
Corydon, Indiana 47112-2174
United StatesSite Not Available
Integrated Clinical Trial Services Inc.
West Des Moines, Iowa 50265
United StatesSite Not Available
Kansas Medical Clinic, PA
Topeka, Kansas 66614
United StatesSite Not Available
Clinical Pharmacology Study Group
Worcester, Massachusetts 01605
United StatesSite Not Available
Hamzavi Dermatology
Fort Gratiot, Michigan 48059
United StatesSite Not Available
Research Site
Fridley, Minnesota 55432
United StatesSite Not Available
Minnesota Clinical Study Center
New Brighton, Minnesota 55112
United StatesSite Not Available
MediSearch Clinical Trials
Saint Joseph, Missouri 64506
United StatesSite Not Available
Skin Specialists PC
Omaha, Nebraska 68144
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
The Dermatology Group, PC
Verona, New Jersey 07044
United StatesSite Not Available
Buffalo Medical Group, PC
Buffalo, New York 14221
United StatesSite Not Available
OnSite Clinical Solutions, LLC
Charlotte, North Carolina 28209
United StatesSite Not Available
Wilmington Dermatology Center
Wilmington, North Carolina 28405
United StatesSite Not Available
Oregon Medical Research Center
Portland, Oregon 97223
United StatesSite Not Available
Austin Institute for Clinical Research, Inc.
Dripping Springs, Texas 78620
United StatesSite Not Available
Austin Institute for Clinical Research, Inc - Dermatology
Pflugerville, Texas 78660
United StatesSite Not Available
Progressive Clinical Research [Texas]
San Antonio, Texas 78213
United StatesSite Not Available
Center for Clinical Studies, LTD., LLP
Webster, Texas 77598
United StatesSite Not Available
Dermatology of Seattle
Burien, Washington 98168
United StatesSite Not Available
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