Head-to-Head: which drug works better for psoriatic arthritis?
NCT ID NCT06624228
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This study tests whether bimekizumab works better than risankizumab for adults with active psoriatic arthritis (PsA), a condition causing joint pain and skin lesions. About 684 participants will receive one of the two drugs for 16 weeks. The main goal is to see who gets at least 50% improvement in joint symptoms. Both drugs are already used for other conditions, and this trial aims to find the best option for PsA.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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553 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (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 a documented history of chronic plaque-type psoriasis (PSO). * Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as 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 previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either: * experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or * been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation). Exclusion Criteria: * Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. * Female participants who are breastfeeding, pregnant, or plan to become pregnant during 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 TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection. * Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis. * Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline. * Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator's opinion would have potential to interfere with efficacy assessments. * Participant has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer. * Participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening. * 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 analgesics as outlined in the Inclusion criteria. * Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit or is taking or has taken weight management medications without meeting the mandatory dose stability period/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 or risankizumab, with the exception of having received 1 prior TNFα inhibitor. * Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pa0016 20031
Sapporo, Japan
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Pa0016 20035
Bunkyō City, Japan
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Pa0016 20041
Osaka, Japan
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Pa0016 20043
Itabashi-ku, Japan
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Pa0016 20045
Kita-gun, Japan
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Pa0016 20046
Osaka, Japan
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Pa0016 20049
Kitakyushu, Japan
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Pa0016 20069
Meguro-ku, Japan
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Pa0016 20336
Mitaka-shi, Japan
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Pa0016 30002
Clayton, Australia
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Pa0016 30003
Maroochydore, Australia
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Pa0016 30009
Westmead, Australia
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Pa0016 30032
Parramatta, Australia
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Pa0016 30033
Heidelberg, Australia
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Pa0016 30034
Footscray, Australia
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Pa0016 40006
Plovdiv, Bulgaria
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Pa0016 40010
Uherské Hradiště, Czechia
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Pa0016 40012
Zlín, Czechia
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Pa0016 40025
Berlin, Germany
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Pa0016 40029
Hamburg, Germany
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Pa0016 40031
Szeged, Hungary
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Pa0016 40037
Lublin, Poland
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Pa0016 40038
Elblag, Poland
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Pa0016 40043
Wroclaw, Poland
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Pa0016 40044
Poznan, Poland
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Pa0016 40049
Seville, Spain
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Pa0016 40062
Moravska Ostrava A Privoz, Czechia
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Pa0016 40065
Brno, Czechia
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Pa0016 40066
Prague, Czechia
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Pa0016 40072
Freiburg im Breisgau, Germany
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Pa0016 40073
Bad Nauheim, Germany
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Pa0016 40081
Budapest, Hungary
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Pa0016 40090
Poznan, Poland
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Pa0016 40091
Nowa Sól, Poland
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Pa0016 40092
Krakow, Poland
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Pa0016 40094
Warsaw, Poland
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Pa0016 40095
Wroclaw, Poland
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Pa0016 40102
Málaga, Spain
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Pa0016 40108
Salford, United Kingdom
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Pa0016 40119
Bydgoszcz, Poland
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Pa0016 40138
Bonn, Germany
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Pa0016 40231
Madrid, Spain
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Pa0016 40237
Manchester, United Kingdom
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Pa0016 40269
Bilbao, Spain
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Pa0016 40281
Leeds, United Kingdom
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Pa0016 40306
Newcastle upon Tyne, United Kingdom
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Pa0016 40313
Pleven, Bulgaria
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Pa0016 40314
Sofia, Bulgaria
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Pa0016 40380
Sofia, Bulgaria
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Pa0016 40394
Warsaw, Poland
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Pa0016 40483
Nadarzyn, Poland
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Pa0016 40490
Krakow, Poland
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Pa0016 40502
Krakow, Poland
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Pa0016 40539
Warsaw, Poland
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Pa0016 40604
Warsaw, Poland
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Pa0016 40656
Rousse, Bulgaria
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Pa0016 40724
München, Germany
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Pa0016 40753
Santiago de Compostela, Spain
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Pa0016 40788
Torun, Poland
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Pa0016 40789
Bialystok, Poland
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Pa0016 40790
Sochaczew, Poland
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Pa0016 40791
Bialystok, Poland
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Pa0016 40792
Krakow, Poland
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Pa0016 40793
Warsaw, Poland
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Pa0016 40794
Opole, Poland
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Pa0016 40795
Katowice, Poland
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Pa0016 40796
Olsztyn, Poland
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Pa0016 40797
Warsaw, Poland
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Pa0016 40798
Bydgoszcz, Poland
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Pa0016 40799
Seville, Spain
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Pa0016 40800
Ratingen, Germany
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Pa0016 40801
Prague, Czechia
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Pa0016 40802
Ostrava, Czechia
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Pa0016 40803
Sabadell, Spain
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Pa0016 40804
Budapest, Hungary
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Pa0016 40805
Wroclaw, Poland
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Pa0016 40806
A Coruña, Spain
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Pa0016 40807
Poznan, Poland
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Pa0016 40808
Cologne, Germany
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Pa0016 40809
Hódmezővásárhely, Hungary
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Pa0016 40810
Herne, Germany
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Pa0016 40811
Sofia, Bulgaria
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Pa0016 40813
Plovdiv, Bulgaria
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Pa0016 40818
Plovdiv, Bulgaria
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Pa0016 40819
Sofia, Bulgaria
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Pa0016 40820
Plovdiv, Bulgaria
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Pa0016 40823
Rousse, Bulgaria
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Pa0016 40824
Bialystok, Poland
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Pa0016 40827
Luton, United Kingdom
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Pa0016 40828
Reading, United Kingdom
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Pa0016 40833
Barnet, United Kingdom
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Pa0016 50001
Jackson, Tennessee, 38305, United States
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Pa0016 50006
Wyomissing, Pennsylvania, 19610, United States
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Pa0016 50016
St Louis, Missouri, 63141, United States
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Pa0016 50041
Québec, Canada
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Pa0016 50044
Trois-Rivières, Canada
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Pa0016 50048
Katy, Texas, 77449, United States
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Pa0016 50058
Phoenix, Arizona, 85032, United States
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Pa0016 50059
Ormond Beach, Florida, 32174, United States
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Pa0016 50061
Spokane Valley, Washington, 99216, United States
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Pa0016 50062
Glendale, Arizona, 85306, United States
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Pa0016 50131
Sun City, Arizona, 85351, United States
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Pa0016 50324
Plantation, Florida, 33324, United States
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Pa0016 50551
Saint Clair Shores, Michigan, 48081, United States
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Pa0016 50630
Clearwater, Florida, 33765, United States
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Pa0016 50650
Willowbrook, Illinois, 60527, United States
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Pa0016 50651
Skokie, Illinois, 60076, United States
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Pa0016 50652
Duncansville, Pennsylvania, 16635, United States
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Pa0016 50653
Albuquerque, New Mexico, 87102, United States
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Pa0016 50654
Covina, California, 91722, United States
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Pa0016 50655
Tomball, Texas, 77375, United States
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Pa0016 50657
Lubbock, Texas, 79424, United States
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Pa0016 50662
Gilbert, Arizona, 85297, United States
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Pa0016 50663
San Diego, California, 92128, United States
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Pa0016 50664
Middletown, Ohio, 45044, United States
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Pa0016 50665
Lansing, Michigan, 48910, United States
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Pa0016 50666
Brooklyn, New York, 11201, United States
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Pa0016 50672
Santa Monica, California, 90404, United States
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Pa0016 50673
Fort Worth, Texas, 76109, United States
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Pa0016 50674
Glendale, Wisconsin, 53217, United States
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Pa0016 50678
Zephyrhills, Florida, 33542, United States
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Pa0016 50679
Cutler Bay, Florida, 33189, United States
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Pa0016 50680
Vandalia, Ohio, 45377, United States
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Pa0016 50682
Kansas City, Missouri, 64111, United States
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Pa0016 50685
Fort Lauderdale, Florida, 33309, United States
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Pa0016 50686
Hagerstown, Maryland, 21740, United States
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Pa0016 50689
Eagan, Minnesota, 55123, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an oral drug calm psoriatic arthritis? phase 3 trial puts deucravacitinib to the test
- Do rheumatic diseases quietly damage the Eye's oil glands?
- Can a questionnaire capture the real burden of psoriatic arthritis?
- Can a new pill calm psoriatic arthritis joint pain?
- A personal nurse and a plan: could this ease the daily burden of arthritis?