Phase
Condition
Arthritis And Arthritic Pain
Bone Diseases
Psoriatic Arthritis
Treatment
Risankizumab
Bimekizumab
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participants must have a documented diagnosis of adult-onset PsA classified byand that meets the CASPAR classification criteria for at least 6 months prior toScreening with active PsA (despite previous csDMARD or apremilast therapy) and musthave at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen jointcount (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each).
Study participant must have at least 1 active psoriatic lesion(s) and/or adocumented history of chronic plaque-type psoriasis (PSO).
Study participants may currently be on conventional synthetic disease-modifyingantirheumatic drug (csDMARD) therapy and must have previously been treated with atleast 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Studyparticipants must have had an inadequate response to therapy or discontinued due tointolerance. (Inadequate response is determined by the Investigator and is definedas not achieving the minimal response after 12 weeks of therapy.)
Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previouslymust not have discontinued the TNFα inhibitor due to financial or health insurancereasons and must have either:
experienced an inadequate response to previous treatment given at an approved dosefor at least 3 months, or
been intolerant to administration (eg, had a side-effect/adverse event (AE) that ledto discontinuation).
Exclusion
Exclusion Criteria:
Study participant has any medical or psychiatric condition that, in the opinion ofthe Investigator, could jeopardize or would compromise the study participant'sability to participate in this study.
Female participants who are breastfeeding, pregnant, or plan to become pregnantduring the study.
Participant has an active infection or a history of recent serious infections.
Participant has known tuberculosis (TB) infection, is at high risk of acquiring TBinfection, or has current or history of nontuberculous mycobacterium (NTMB)infection.
Study participant has a diagnosis of inflammatory conditions other than PSO or PsAincluding, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupuserythematosus, reactive arthritis, and axial spondyloarthritis.
Study participants with a history of anterior uveitis are allowed if they have noactive symptoms at Screening or Baseline. Study participants with a diagnosis ofCrohn's disease or ulcerative colitis are allowed if they have no active symptomaticdisease at Screening or Baseline.
Study participants with fibromyalgia or osteoarthritis symptoms that in theInvestigator's opinion would have potential to interfere with efficacy assessments.
Participant has any active malignancy or history of malignancy within 5 years priorto the Screening Visit EXCEPT treated and considered cured cutaneous squamous orbasal cell carcinoma, or in situ cervical cancer.
Participant has a history of chronic alcohol or drug abuse within 6 months prior toScreening.
Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ,apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesicsas outlined in the Inclusion criteria.
Study participant is taking or has taken prohibited PsA or PSO medications withoutmeeting the mandatory wash-out period relative to the Baseline Visit or is taking orhas taken weight management medications without meeting the mandatory dose stabilityperiod/washout period relative to the Baseline Visit.
Study participant is taking or has taken janus kinase (JAK) inhibitor.
Study participant is taking or has taken bDMARDs, including bimekizumab orrisankizumab, with the exception of having received 1 prior TNFα inhibitor.
Study participant previously participated in another study of a medical device underinvestigation within the 4 weeks prior to the Screening Visit or is currentlyparticipating in another study of a medical device under investigation.
Study Design
Connect with a study center
Pa0016 30002
Clayton,
AustraliaSite Not Available
Pa0016 30034
Footscray,
AustraliaSite Not Available
Pa0016 30033
Heidelberg,
AustraliaSite Not Available
Pa0016 30003
Maroochydore,
AustraliaSite Not Available
Pa0016 30032
Parramatta,
AustraliaSite Not Available
Pa0016 30009
Westmead,
AustraliaSite Not Available
Pa0016 40313
Pleven,
BulgariaSite Not Available
Pa0016 40006
Plovdiv,
BulgariaSite Not Available
Pa0016 40813
Plovdiv,
BulgariaSite Not Available
Pa0016 40818
Plovdiv,
BulgariaSite Not Available
Pa0016 40820
Plovdiv,
BulgariaSite Not Available
Pa0016 40006
Plovdiv 728193,
BulgariaSite Not Available
Pa0016 40813
Plovdiv 728193,
BulgariaSite Not Available
Pa0016 40820
Plovdiv 728193,
BulgariaSite Not Available
Pa0016 40656
Rousse,
BulgariaSite Not Available
Pa0016 40823
Rousse,
BulgariaSite Not Available
Pa0016 40656
Rousse 727523,
BulgariaSite Not Available
Pa0016 40314
Sofia,
BulgariaSite Not Available
Pa0016 40380
Sofia,
BulgariaSite Not Available
Pa0016 40811
Sofia,
BulgariaSite Not Available
Pa0016 40819
Sofia,
BulgariaSite Not Available
Pa0016 40314
Sofia 727011,
BulgariaSite Not Available
Pa0016 40380
Sofia 727011,
BulgariaSite Not Available
Pa0016 40819
Sofia 727011,
BulgariaSite Not Available
Pa0016 50041
Québec,
CanadaSite Not Available
Pa0016 50044
Trois-Rivières,
CanadaSite Not Available
Pa0016 40065
Brno,
CzechiaSite Not Available
Pa0016 40062
Moravska Ostrava A Privoz,
CzechiaSite Not Available
Pa0016 40062
Ostrava,
CzechiaActive - Recruiting
Pa0016 40802
Ostrava,
CzechiaSite Not Available
Pa0016 40066
Prague,
CzechiaSite Not Available
Pa0016 40801
Prague,
CzechiaSite Not Available
Pa0016 40801
Prague 3067696,
CzechiaSite Not Available
Pa0016 40010
Uherské Hradiště,
CzechiaSite Not Available
Pa0016 40012
Zlín,
CzechiaSite Not Available
Pa0016 40073
Bad Nauheim,
GermanySite Not Available
Pa0016 40025
Berlin,
GermanySite Not Available
Pa0016 40515
Berlin 2950159,
GermanySite Not Available
Pa0016 40138
Bonn,
GermanySite Not Available
Pa0016 40808
Cologne,
GermanySite Not Available
Pa0016 40072
Freiburg im Breisgau,
GermanySite Not Available
Pa0016 40029
Hamburg,
GermanySite Not Available
Pa0016 40810
Herne,
GermanySite Not Available
Pa0016 40724
München,
GermanySite Not Available
Pa0016 40800
Ratingen,
GermanySite Not Available
Pa0016 40081
Budapest,
HungarySite Not Available
Pa0016 40804
Budapest,
HungarySite Not Available
Pa0016 40081
Budapest 3054643,
HungarySite Not Available
Pa0016 40809
Hódmezővásárhely,
HungarySite Not Available
Pa0016 40031
Szeged,
HungarySite Not Available
Pa0016 20035
Bunkyō City,
JapanSite Not Available
Pa0016 20043
Itabashi-ku,
JapanSite Not Available
Pa0016 20045
Kita-gun,
JapanSite Not Available
Pa0016 20049
Kitakyushu,
JapanSite Not Available
Pa0016 20069
Meguro-ku,
JapanSite Not Available
Pa0016 20336
Mitaka-shi,
JapanSite Not Available
Pa0016 20041
Osaka,
JapanSite Not Available
Pa0016 20046
Osaka,
JapanSite Not Available
Pa0016 20046
Osaka 1853909,
JapanSite Not Available
Pa0016 20031
Sapporo,
JapanSite Not Available
Pa0016 40789
Bialystok,
PolandSite Not Available
Pa0016 40791
Bialystok,
PolandSite Not Available
Pa0016 40824
Bialystok,
PolandSite Not Available
Pa0016 40791
Bialystok 776069,
PolandSite Not Available
Pa0016 40824
Bialystok 776069,
PolandSite Not Available
Pa0016 40119
Bydgoszcz,
PolandSite Not Available
Pa0016 40798
Bydgoszcz,
PolandSite Not Available
Pa0016 40798
Bydgoszcz 3102014,
PolandSite Not Available
Pa0016 40038
Elblag,
PolandSite Not Available
Pa0016 40795
Katowice,
PolandSite Not Available
Pa0016 40092
Krakow,
PolandSite Not Available
Pa0016 40490
Krakow,
PolandSite Not Available
Pa0016 40502
Krakow,
PolandSite Not Available
Pa0016 40792
Krakow,
PolandSite Not Available
Pa0016 40092
Krakow 3094802,
PolandSite Not Available
Pa0016 40490
Krakow 3094802,
PolandSite Not Available
Pa0016 40792
Krakow 3094802,
PolandSite Not Available
Pa0016 40037
Lublin,
PolandSite Not Available
Pa0016 40483
Nadarzyn,
PolandSite Not Available
Pa0016 40091
Nowa Sól,
PolandSite Not Available
Pa0016 40796
Olsztyn,
PolandSite Not Available
Pa0016 40794
Opole,
PolandSite Not Available
Pa0016 40044
Poznan,
PolandSite Not Available
Pa0016 40090
Poznan,
PolandSite Not Available
Pa0016 40807
Poznan,
PolandSite Not Available
Pa0016 40044
Poznan 3088171,
PolandSite Not Available
Pa0016 40090
Poznan 3088171,
PolandSite Not Available
Pa0016 40790
Sochaczew,
PolandSite Not Available
Pa0016 40788
Torun,
PolandSite Not Available
Pa0016 40094
Warsaw,
PolandSite Not Available
Pa0016 40394
Warsaw,
PolandSite Not Available
Pa0016 40539
Warsaw,
PolandSite Not Available
Pa0016 40604
Warsaw,
PolandSite Not Available
Pa0016 40793
Warsaw,
PolandSite Not Available
Pa0016 40797
Warsaw,
PolandSite Not Available
Pa0016 40094
Warsaw 756135,
PolandSite Not Available
Pa0016 40394
Warsaw 756135,
PolandSite Not Available
Pa0016 40604
Warsaw 756135,
PolandSite Not Available
Pa0016 40793
Warsaw 756135,
PolandSite Not Available
Pa0016 40797
Warsaw 756135,
PolandSite Not Available
Pa0016 40094
Warszawa,
PolandActive - Recruiting
Pa0016 40539
Warszawa,
PolandActive - Recruiting
Pa0016 40604
Warszawa,
PolandActive - Recruiting
Pa0016 40793
Warszawa,
PolandActive - Recruiting
Pa0016 40797
Warszawa,
PolandActive - Recruiting
Pa0016 40043
Wroclaw,
PolandSite Not Available
Pa0016 40095
Wroclaw,
PolandSite Not Available
Pa0016 40805
Wroclaw,
PolandSite Not Available
Pa0016 40043
Wroclaw 3081368,
PolandSite Not Available
Pa0016 40095
Wroclaw 3081368,
PolandSite Not Available
Pa0016 40806
A Coruña,
SpainSite Not Available
Pa0016 40269
Bilbao,
SpainSite Not Available
Pa0016 40231
Madrid,
SpainSite Not Available
Pa0016 40102
Málaga,
SpainSite Not Available
Pa0016 40803
Sabadell,
SpainSite Not Available
Pa0016 40753
Santiago de Compostela,
SpainSite Not Available
Pa0016 40799
Sevilla,
SpainActive - Recruiting
Pa0016 40049
Seville,
SpainSite Not Available
Pa0016 40799
Seville,
SpainSite Not Available
Pa0016 40049
Seville 2510911,
SpainSite Not Available
Pa0016 40833
Barnet,
United KingdomSite Not Available
Pa0016 40281
Leeds,
United KingdomSite Not Available
Pa0016 40827
Luton,
United KingdomSite Not Available
Pa0016 40237
Manchester,
United KingdomSite Not Available
Pa0016 40306
Newcastle upon Tyne,
United KingdomSite Not Available
Pa0016 40828
Reading,
United KingdomSite Not Available
Pa0016 40108
Salford,
United KingdomSite Not Available
Pa0016 50662
Gilbert, Arizona 85297
United StatesSite Not Available
Pa0016 50062
Glendale, Arizona 85306
United StatesSite Not Available
Pa0016 50058
Phoenix, Arizona 85032
United StatesSite Not Available
Pa0016 50131
Sun City, Arizona 85351
United StatesSite Not Available
Pa0016 50654
Covina, California 91722
United StatesSite Not Available
Pa0016 50663
San Diego, California 92128
United StatesSite Not Available
Pa0016 50672
Santa Monica, California 90404
United StatesSite Not Available
Pa0016 50630
Clearwater, Florida 33765
United StatesSite Not Available
Pa0016 50679
Cutler Bay, Florida 33189
United StatesSite Not Available
Pa0016 50685
Fort Lauderdale, Florida 33309
United StatesSite Not Available
Pa0016 50059
Ormond Beach, Florida 32174
United StatesSite Not Available
Pa0016 50324
Plantation, Florida 33324
United StatesSite Not Available
Pa0016 50678
Zephyrhills, Florida 33542
United StatesSite Not Available
Pa0016 50651
Skokie, Illinois 60076
United StatesSite Not Available
Pa0016 50650
Willowbrook, Illinois 60527
United StatesSite Not Available
Pa0016 50686
Hagerstown, Maryland 21740
United StatesSite Not Available
Pa0016 50665
Lansing, Michigan 48910
United StatesSite Not Available
Pa0016 50551
Saint Clair Shores, Michigan 48081
United StatesSite Not Available
Pa0016 50689
Eagan, Minnesota 55123
United StatesSite Not Available
Pa0016 50689
Eagan 5024825, Minnesota 5037779 55121
United StatesSite Not Available
Pa0016 50682
Kansas City, Missouri 64111
United StatesSite Not Available
Pa0016 50016
St Louis, Missouri 63141
United StatesSite Not Available
Pa0016 50682
Kansas City 4393217, Missouri 4398678 64151
United StatesSite Not Available
Pa0016 50653
Albuquerque, New Mexico 87102
United StatesSite Not Available
Pa0016 50666
Brooklyn, New York 11201
United StatesSite Not Available
Pa0016 50664
Middletown, Ohio 45044
United StatesSite Not Available
Pa0016 50680
Vandalia, Ohio 45377
United StatesSite Not Available
Pa0016 50652
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Pa0016 50006
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
Pa0016 50001
Jackson, Tennessee 38305
United StatesSite Not Available
Pa0016 50673
Fort Worth, Texas 76109
United StatesSite Not Available
Pa0016 50048
Katy, Texas 77449
United StatesSite Not Available
Pa0016 50657
Lubbock, Texas 79424
United StatesSite Not Available
Pa0016 50655
Tomball, Texas 77375
United StatesSite Not Available
Pa0016 50061
Spokane Valley, Washington 99216
United StatesSite Not Available
Pa0016 50674
Glendale, Wisconsin 53217
United StatesSite Not Available

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