Phase
Condition
Joint Injuries
Psoriatic Arthritis
Psoriasis And Psoriatic Disorders
Treatment
Adalimumab
Bimekizumab
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approvedwritten Informed Consent form is signed and dated by the subject
Subject is male or female at least 18 years of age
Female subject must be postmenopausal, permanently sterilized or willing to use ahighly effective method of contraception
Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting theClassification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months priorto Screening with active PsA and must have at Baseline tender joint count (TJC) >=3out of 68 and swollen joint count (SJC) >=3 out of 66
Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
Subject must have at least 1 active psoriatic lesion(s) and/or a documented historyof psoriasis (PSO)
Subject must be a suitable candidate for treatment with adalimumab and has nocontraindications to receive adalimumab as per the local label as assessed by theInvestigator
Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF),sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed ifthey fulfill specific requirements prior to study entry
Exclusion
Exclusion Criteria:
Female subjects who are breastfeeding, pregnant, or plan to become pregnant duringthe study
Subjects with current or prior exposure to any biologics for the treatment ofPsoriatic Arthritis (PsA) or Psoriasis (PSO)
Subject has an active infection or a history of recent serious infections
Subject has known tuberculosis (TB) infection, is at high risk of acquiring TBinfection, or has current or history of nontuberculous mycobacterium (NTMB)infection
Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjectswith a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory boweldisease (IBD) are allowed as long as they have no active symptomatic disease atScreening or Baseline
Subject had acute anterior uveitis within 6 weeks of Baseline
Subject has any active malignancy or history of malignancy within 5 years prior tothe Screening Visit EXCEPT treated and considered cured cutaneous squamous or basalcell carcinoma, or in situ cervical cancer
Subject has a form of PSO other than chronic plaque-type (eg, pustular,erythrodermic and guttate PSO, or drug-induced PSO)
Presence of active suicidal ideation, or moderately severe major depression orsevere major depression
Subject has a history of chronic alcohol or drug abuse within 6 months prior toScreening
Study Design
Connect with a study center
Pa0010 30005
Camberwell,
AustraliaSite Not Available
Pa0010 30002
Clayton,
AustraliaSite Not Available
Pa0010 30001
Footscray,
AustraliaSite Not Available
Pa0010 30008
Hobart,
AustraliaSite Not Available
Pa0010 30004
Liverpool,
AustraliaSite Not Available
Pa0010 30003
Maroochydore,
AustraliaSite Not Available
Pa0010 30007
Victoria Park,
AustraliaSite Not Available
Pa0010 30006
Woodville,
AustraliaSite Not Available
Pa0010 40058
Brussels,
BelgiumSite Not Available
Pa0010 40003
Genk,
BelgiumSite Not Available
Pa0010 40002
Leuven,
BelgiumSite Not Available
Pa0010 40060
Liège,
BelgiumSite Not Available
Pa0010 40059
Mons,
BelgiumSite Not Available
Pa0010 50041
Québec City,
CanadaSite Not Available
Pa0010 50042
Rimouski,
CanadaSite Not Available
Pa0010 50043
Sidney,
CanadaSite Not Available
Pa0010 50045
Toronto,
CanadaSite Not Available
Pa0010 50044
Trois-Rivières,
CanadaSite Not Available
Pa0010 40061
Brno,
CzechiaSite Not Available
Pa0010 40065
Brno,
CzechiaSite Not Available
Pa0010 40064
Olomouc,
CzechiaSite Not Available
Pa0010 40062
Ostrava,
CzechiaSite Not Available
Pa0010 40009
Pardubice,
CzechiaSite Not Available
Pa0010 40015
Praha,
CzechiaSite Not Available
Pa0010 40013
Praha 11,
CzechiaSite Not Available
Pa0010 40066
Praha 2,
CzechiaSite Not Available
Pa0010 40014
Praha 4,
CzechiaSite Not Available
Pa0010 40063
Praha 5,
CzechiaSite Not Available
Pa0010 40010
Uherské Hradiště,
CzechiaSite Not Available
Pa0010 40012
Ziln,
CzechiaSite Not Available
Pa0010 40012
Zlín,
CzechiaSite Not Available
Pa0010 40070
Clermont-Ferrand,
FranceSite Not Available
Pa0010 40067
Lyon,
FranceSite Not Available
Pa0010 40019
Paris,
FranceSite Not Available
Pa0010 40068
Tours,
FranceSite Not Available
Pa0010 40074
Bad Doberan,
GermanySite Not Available
Pa0010 40025
Berlin,
GermanySite Not Available
Pa0010 40028
Berlin,
GermanySite Not Available
Pa0010 40076
Cottbus,
GermanySite Not Available
Pa0010 40023
Erlangen,
GermanySite Not Available
Pa0010 40117
Frankfurt,
GermanySite Not Available
Pa0010 40029
Hamburg,
GermanySite Not Available
Pa0010 40071
Hamburg,
GermanySite Not Available
Pa0010 40027
Herne,
GermanySite Not Available
Pa0010 40077
Hildesheim,
GermanySite Not Available
Pa0010 40078
Leipzig,
GermanySite Not Available
Pa0010 40348
Magdeburg,
GermanySite Not Available
Pa0010 40026
Ratingen,
GermanySite Not Available
Pa0010 40081
Budapest,
HungarySite Not Available
Pa0010 40083
Budapest,
HungarySite Not Available
Pa0010 40032
Debrecen,
HungarySite Not Available
Pa0010 40030
Eger,
HungarySite Not Available
Pa0010 40082
Kistarcsa,
HungarySite Not Available
Pa0010 40079
Szentes,
HungarySite Not Available
Pa0010 40080
Szombathely,
HungarySite Not Available
Pa0010 40033
Székesfehérvár,
HungarySite Not Available
Pa0010 40084
Catania,
ItalySite Not Available
Pa0010 40087
Milano,
ItalySite Not Available
Pa0010 40085
Pisa,
ItalySite Not Available
Pa0010 40086
Reggio Emilia,
ItalySite Not Available
Pa0010 20035
Bunkyō-Ku,
JapanSite Not Available
Pa0010 20043
Itabashi,
JapanSite Not Available
Pa0010 20036
Kawachi-Nagano-shi,
JapanSite Not Available
Pa0010 20045
Kita,
JapanSite Not Available
Pa0010 20049
Kitakyushu,
JapanSite Not Available
Pa0010 20044
Minato-Ku,
JapanSite Not Available
Pa0010 20033
Nagoya,
JapanSite Not Available
Pa0010 20038
Nankoku,
JapanSite Not Available
Pa0010 20041
Osaka,
JapanSite Not Available
Pa0010 20046
Osaka,
JapanSite Not Available
Pa0010 20048
Saitama,
JapanSite Not Available
Pa0010 20031
Sapporo-City,
JapanSite Not Available
Pa0010 20042
Sasebo,
JapanSite Not Available
Pa0010 20032
Suita,
JapanSite Not Available
Pa0010 20030
Tokyo,
JapanSite Not Available
Pa0010 40093
Białystok,
PolandSite Not Available
Pa0010 40119
Bydgoszcz,
PolandSite Not Available
Pa0010 40038
Elbląg,
PolandSite Not Available
Pa0010 40088
Elbląg,
PolandSite Not Available
Pa0010 40096
Gdynia,
PolandSite Not Available
Pa0010 40042
Kraków,
PolandSite Not Available
Pa0010 40092
Kraków,
PolandSite Not Available
Pa0010 40037
Lublin,
PolandSite Not Available
Pa0010 40091
Nowa Sól,
PolandSite Not Available
Pa0010 40044
Poznań,
PolandSite Not Available
Pa0010 40090
Poznań,
PolandSite Not Available
Pa0010 40118
Toruń,
PolandSite Not Available
Pa0010 40041
Warszawa,
PolandSite Not Available
Pa0010 40094
Warszawa,
PolandSite Not Available
Pa0010 40097
Warszawa,
PolandSite Not Available
Pa0010 40098
Warszawa,
PolandSite Not Available
Pa0010 40039
Wrocław,
PolandSite Not Available
Pa0010 40043
Wrocław,
PolandSite Not Available
Pa0010 40095
Wrocław,
PolandSite Not Available
Pa0010 20002
Moscow,
Russian FederationSite Not Available
Pa0010 20005
Moscow,
Russian FederationSite Not Available
Pa0010 20010
Moscow,
Russian FederationSite Not Available
Pa0010 20017
Moscow,
Russian FederationSite Not Available
Pa0010 20013
Petrozavodsk,
Russian FederationSite Not Available
Pa0010 20012
Ryazan',
Russian FederationSite Not Available
Pa0010 20016
Ryazan',
Russian FederationSite Not Available
Pa0010 20001
Saint Petersburg,
Russian FederationSite Not Available
Pa0010 20003
Saint Petersburg,
Russian FederationSite Not Available
Pa0010 20004
Saint Petersburg,
Russian FederationSite Not Available
Pa0010 20009
Saint Petersburg,
Russian FederationSite Not Available
Pa0010 20083
Saint Petersburg,
Russian FederationSite Not Available
Pa0010 20007
Saratov,
Russian FederationSite Not Available
Pa0010 20014
Ulyanovsk,
Russian FederationSite Not Available
Pa0010 20006
Vladimir,
Russian FederationSite Not Available
Pa0010 20008
Yaroslavl,
Russian FederationSite Not Available
Pa0010 20015
Yaroslavl,
Russian FederationSite Not Available
Pa0010 40045
Coruña,
SpainSite Not Available
Pa0010 40105
Córdoba,
SpainSite Not Available
Pa0010 40100
Madrid,
SpainSite Not Available
Pa0010 40102
Málaga,
SpainSite Not Available
Pa0010 40101
Sabadell,
SpainSite Not Available
Pa0010 40104
Santiago De Compostela,
SpainSite Not Available
Pa0010 40049
Sevilla,
SpainSite Not Available
Pa0010 40103
Sevilla,
SpainSite Not Available
Pa0010 40106
Sevilla,
SpainSite Not Available
Pa0010 40099
Vigo,
SpainSite Not Available
Pa0010 40115
Barnsley,
United KingdomSite Not Available
Pa0010 40112
Cornwell,
United KingdomSite Not Available
Pa0010 40111
Leeds,
United KingdomSite Not Available
Pa0010 40109
Oxford,
United KingdomSite Not Available
Pa0010 40110
Wirral,
United KingdomSite Not Available
Pa0010 40107
Wolverhampton,
United KingdomSite Not Available
Pa0010 50017
Phoenix, Arizona 85037
United StatesSite Not Available
Pa0010 50035
San Diego, California 92025
United StatesSite Not Available
Pa0010 50004
Tustin, California 92780
United StatesSite Not Available
Pa0010 50025
Ocoee, Florida 34761
United StatesSite Not Available
Pa0010 50025
Orlando, Florida 34761
United StatesSite Not Available
Pa0010 50033
Palm Harbor, Florida 34684
United StatesSite Not Available
Pa0010 50037
Tampa, Florida 33613
United StatesSite Not Available
Pa0010 50039
Atlanta, Georgia 30342
United StatesSite Not Available
Pa0010 50028
Lexington, Kentucky 40504
United StatesSite Not Available
Pa0010 50023
Baton Rouge, Louisiana 70836
United StatesSite Not Available
Pa0010 50015
Hagerstown, Maryland 21742
United StatesSite Not Available
Pa0010 50016
Saint Louis, Missouri 63141
United StatesSite Not Available
Pa0010 50029
Albuquerque, New Mexico 87102
United StatesSite Not Available
Pa0010 50010
Brooklyn, New York 11201
United StatesSite Not Available
Pa0010 50125
Charlotte, North Carolina 28210
United StatesSite Not Available
Pa0010 50013
Wilmington, North Carolina 28401
United StatesSite Not Available
Pa0010 50040
Dayton, Ohio 45417
United StatesSite Not Available
Pa0010 50020
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Pa0010 50006
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
Pa0010 50008
Johnston, Rhode Island 02919
United StatesSite Not Available
Pa0010 50007
Orangeburg, South Carolina 29118
United StatesSite Not Available
Pa0010 50021
Summerville, South Carolina 29486
United StatesSite Not Available
Pa0010 50001
Jackson, Tennessee 38305
United StatesSite Not Available
Pa0010 50012
Memphis, Tennessee 38119
United StatesSite Not Available
Pa0010 50002
Austin, Texas 78731
United StatesSite Not Available
Pa0010 50046
Baytown, Texas 77521
United StatesSite Not Available
Pa0010 50049
Corpus Christi, Texas 78404
United StatesSite Not Available
Pa0010 50051
Houston, Texas 77034
United StatesSite Not Available
Pa0010 50036
Mesquite, Texas 75150
United StatesSite Not Available
Pa0010 50009
Waco, Texas 76710
United StatesSite Not Available
Pa0010 50022
Chesapeake, Virginia 23320
United StatesSite Not Available
Pa0010 50027
Seattle, Washington 98122
United StatesSite Not Available
Pa0010 50050
Beckley, West Virginia 25801
United StatesSite Not Available

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