Phase
Condition
Joint Injuries
Psoriatic Arthritis
Bone Diseases
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.
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,
AustraliaActive - Recruiting
Pa0016 30033
Heidelberg,
AustraliaActive - Recruiting
Pa0016 30003
Maroochydore,
AustraliaActive - Recruiting
Pa0016 30032
Parramatta,
AustraliaActive - Recruiting
Pa0016 40313
Pleven,
BulgariaActive - Recruiting
Pa0016 40813
Plovdiv,
BulgariaActive - Recruiting
Pa0016 40820
Plovdiv,
BulgariaActive - Recruiting
Pa0016 40823
Ruse,
BulgariaActive - Recruiting
Pa0016 40656
Russe,
BulgariaActive - Recruiting
Pa0016 40314
Sofia,
BulgariaActive - Recruiting
Pa0016 40811
Sofia,
BulgariaActive - Recruiting
Pa0016 40819
Sofia,
BulgariaActive - Recruiting
Pa0016 50041
Quebec,
CanadaActive - Recruiting
Pa0016 50044
Trois-rivieres,
CanadaActive - Recruiting
Pa0016 40065
Brno,
CzechiaActive - Recruiting
Pa0016 40062
Ostrava,
CzechiaActive - Recruiting
Pa0016 40802
Ostrava,
CzechiaActive - Recruiting
Pa0016 40801
Praha 4,
CzechiaActive - Recruiting
Pa0016 40010
Uherske Hradiste,
CzechiaActive - Recruiting
Pa0016 40012
Zlin,
CzechiaActive - Recruiting
Pa0016 40025
Berlin,
GermanyActive - Recruiting
Pa0016 40515
Berlin,
GermanyActive - Recruiting
Pa0016 40138
Bonn,
GermanyActive - Recruiting
Pa0016 40808
Cologne,
GermanyActive - Recruiting
Pa0016 40029
Hamburg,
GermanyActive - Recruiting
Pa0016 40810
Herne,
GermanyActive - Recruiting
Pa0016 40724
München,
GermanyActive - Recruiting
Pa0016 40800
Ratingen,
GermanyActive - Recruiting
Pa0016 40081
Budapest,
HungaryActive - Recruiting
Pa0016 40804
Budapest,
HungaryActive - Recruiting
Pa0016 40809
Hodmezovasarhely,
HungaryActive - Recruiting
Pa0016 40031
Szeged,
HungaryActive - Recruiting
Pa0016 20035
Bunkyo-ku,
JapanActive - Recruiting
Pa0016 20043
Itabashi-ku,
JapanActive - Recruiting
Pa0016 20049
Kitakyushu,
JapanActive - Recruiting
Pa0016 20033
Nagoya,
JapanActive - Recruiting
Pa0016 20041
Osaka,
JapanActive - Recruiting
Pa0016 20046
Osaka,
JapanActive - Recruiting
Pa0016 20031
Sapporo,
JapanActive - Recruiting
Pa0016 20335
Yokohama,
JapanActive - Recruiting
Pa0016 40789
Bialystok,
PolandActive - Recruiting
Pa0016 40791
Bialystok,
PolandActive - Recruiting
Pa0016 40824
Bialystok,
PolandActive - Recruiting
Pa0016 40119
Bydgoszcz,
PolandActive - Recruiting
Pa0016 40798
Bydgoszcz,
PolandActive - Recruiting
Pa0016 40038
Elblag,
PolandActive - Recruiting
Pa0016 40795
Katowice,
PolandActive - Recruiting
Pa0016 40092
Krakow,
PolandActive - Recruiting
Pa0016 40490
Krakow,
PolandSite Not Available
Pa0016 40502
Krakow,
PolandActive - Recruiting
Pa0016 40792
Krakow,
PolandActive - Recruiting
Pa0016 40037
Lublin,
PolandActive - Recruiting
Pa0016 40483
Nadarzyn,
PolandActive - Recruiting
Pa0016 40091
Nowa Sol,
PolandActive - Recruiting
Pa0016 40796
Olsztyn,
PolandActive - Recruiting
Pa0016 40794
Opole,
PolandActive - Recruiting
Pa0016 40044
Poznan,
PolandActive - Recruiting
Pa0016 40090
Poznan,
PolandActive - Recruiting
Pa0016 40807
Poznan,
PolandActive - Recruiting
Pa0016 40790
Sochaczew,
PolandSite Not Available
Pa0016 40788
Torun,
PolandActive - Recruiting
Pa0016 40094
Warszawa,
PolandActive - Recruiting
Pa0016 40394
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,
PolandActive - Recruiting
Pa0016 40095
Wroclaw,
PolandActive - Recruiting
Pa0016 40805
Wroclaw,
PolandActive - Recruiting
Pa0016 40806
A Coruna,
SpainActive - Recruiting
Pa0016 40231
Madrid,
SpainActive - Recruiting
Pa0016 40102
Málaga,
SpainActive - Recruiting
Pa0016 40753
Santiago de Compostela,
SpainActive - Recruiting
Pa0016 40049
Sevilla,
SpainActive - Recruiting
Pa0016 40799
Sevilla,
SpainActive - Recruiting
Pa0016 40828
Reading,
United KingdomActive - Recruiting
Pa0016 50662
Gilbert, Arizona 85297
United StatesActive - Recruiting
Pa0016 50062
Glendale, Arizona 85306
United StatesActive - Recruiting
Pa0016 50058
Phoenix, Arizona 85032
United StatesActive - Recruiting
Pa0016 50677
Scottsdale, Arizona 85258
United StatesActive - Recruiting
Pa0016 50131
Sun City, Arizona 85351
United StatesActive - Recruiting
Pa0016 50654
Covina, California 91722
United StatesActive - Recruiting
Pa0016 50663
San Diego, California 92128
United StatesActive - Recruiting
Pa0016 50672
Santa Monica, California 90404
United StatesActive - Recruiting
Pa0016 50239
Brandon, Florida 33511
United StatesActive - Recruiting
Pa0016 50630
Clearwater, Florida 33765
United StatesActive - Recruiting
Pa0016 50679
Cutler Bay, Florida 33189
United StatesActive - Recruiting
Pa0016 50685
Fort Lauderdale, Florida 33309
United StatesActive - Recruiting
Pa0016 50059
Ormond Beach, Florida 32174
United StatesActive - Recruiting
Pa0016 50678
Zephyrhills, Florida 33542
United StatesActive - Recruiting
Pa0016 50650
Hinsdale, Illinois 60521-3186
United StatesSite Not Available
Pa0016 50651
Skokie, Illinois 60076
United StatesActive - Recruiting
Pa0016 50650
Willowbrook, Illinois 60527
United StatesActive - Recruiting
Pa0016 50686
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Pa0016 50665
Okemos, Michigan 48864
United StatesActive - Recruiting
Pa0016 50551
Saint Clair Shores, Michigan 48081
United StatesActive - Recruiting
Pa0016 50689
Eagan, Minnesota 55121
United StatesActive - Recruiting
Pa0016 50682
Kansas City, Missouri 64151
United StatesActive - Recruiting
Pa0016 50016
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Pa0016 50653
Albuquerque, New Mexico 87102
United StatesActive - Recruiting
Pa0016 50666
Brooklyn, New York 11201
United StatesActive - Recruiting
Pa0016 50521
New York, New York 10003
United StatesActive - Recruiting
Pa0016 50664
Middletown, Ohio 45044
United StatesActive - Recruiting
Pa0016 50680
Vandalia, Ohio 45377
United StatesActive - Recruiting
Pa0016 50652
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Pa0016 50006
Wyomissing, Pennsylvania 19610
United StatesActive - Recruiting
Pa0016 50001
Jackson, Tennessee 38305
United StatesActive - Recruiting
Pa0016 50048
Baytown, Texas 77521
United StatesActive - Recruiting
Pa0016 50673
Fort Worth, Texas 76109
United StatesActive - Recruiting
Pa0016 50657
Lubbock, Texas 79424
United StatesActive - Recruiting
Pa0016 50655
Tomball, Texas 77375
United StatesActive - Recruiting
Pa0016 50061
Spokane, Washington 99204
United StatesActive - Recruiting
Pa0016 50674
Glendale, Wisconsin 53217
United StatesActive - Recruiting
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