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Head-to-Head: which drug works better for psoriatic arthritis?

NCT ID NCT06624228

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

553 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Pa0016 20031

    Sapporo, Japan

  • Pa0016 20035

    Bunkyō City, Japan

  • Pa0016 20041

    Osaka, Japan

  • Pa0016 20043

    Itabashi-ku, Japan

  • Pa0016 20045

    Kita-gun, Japan

  • Pa0016 20046

    Osaka, Japan

  • Pa0016 20049

    Kitakyushu, Japan

  • Pa0016 20069

    Meguro-ku, Japan

  • Pa0016 20336

    Mitaka-shi, Japan

  • Pa0016 30002

    Clayton, Australia

  • Pa0016 30003

    Maroochydore, Australia

  • Pa0016 30009

    Westmead, Australia

  • Pa0016 30032

    Parramatta, Australia

  • Pa0016 30033

    Heidelberg, Australia

  • Pa0016 30034

    Footscray, Australia

  • Pa0016 40006

    Plovdiv, Bulgaria

  • Pa0016 40010

    Uherské Hradiště, Czechia

  • Pa0016 40012

    Zlín, Czechia

  • Pa0016 40025

    Berlin, Germany

  • Pa0016 40029

    Hamburg, Germany

  • Pa0016 40031

    Szeged, Hungary

  • Pa0016 40037

    Lublin, Poland

  • Pa0016 40038

    Elblag, Poland

  • Pa0016 40043

    Wroclaw, Poland

  • Pa0016 40044

    Poznan, Poland

  • Pa0016 40049

    Seville, Spain

  • Pa0016 40062

    Moravska Ostrava A Privoz, Czechia

  • Pa0016 40065

    Brno, Czechia

  • Pa0016 40066

    Prague, Czechia

  • Pa0016 40072

    Freiburg im Breisgau, Germany

  • Pa0016 40073

    Bad Nauheim, Germany

  • Pa0016 40081

    Budapest, Hungary

  • Pa0016 40090

    Poznan, Poland

  • Pa0016 40091

    Nowa Sól, Poland

  • Pa0016 40092

    Krakow, Poland

  • Pa0016 40094

    Warsaw, Poland

  • Pa0016 40095

    Wroclaw, Poland

  • Pa0016 40102

    Málaga, Spain

  • Pa0016 40108

    Salford, United Kingdom

  • Pa0016 40119

    Bydgoszcz, Poland

  • Pa0016 40138

    Bonn, Germany

  • Pa0016 40231

    Madrid, Spain

  • Pa0016 40237

    Manchester, United Kingdom

  • Pa0016 40269

    Bilbao, Spain

  • Pa0016 40281

    Leeds, United Kingdom

  • Pa0016 40306

    Newcastle upon Tyne, United Kingdom

  • Pa0016 40313

    Pleven, Bulgaria

  • Pa0016 40314

    Sofia, Bulgaria

  • Pa0016 40380

    Sofia, Bulgaria

  • Pa0016 40394

    Warsaw, Poland

  • Pa0016 40483

    Nadarzyn, Poland

  • Pa0016 40490

    Krakow, Poland

  • Pa0016 40502

    Krakow, Poland

  • Pa0016 40539

    Warsaw, Poland

  • Pa0016 40604

    Warsaw, Poland

  • Pa0016 40656

    Rousse, Bulgaria

  • Pa0016 40724

    München, Germany

  • Pa0016 40753

    Santiago de Compostela, Spain

  • Pa0016 40788

    Torun, Poland

  • Pa0016 40789

    Bialystok, Poland

  • Pa0016 40790

    Sochaczew, Poland

  • Pa0016 40791

    Bialystok, Poland

  • Pa0016 40792

    Krakow, Poland

  • Pa0016 40793

    Warsaw, Poland

  • Pa0016 40794

    Opole, Poland

  • Pa0016 40795

    Katowice, Poland

  • Pa0016 40796

    Olsztyn, Poland

  • Pa0016 40797

    Warsaw, Poland

  • Pa0016 40798

    Bydgoszcz, Poland

  • Pa0016 40799

    Seville, Spain

  • Pa0016 40800

    Ratingen, Germany

  • Pa0016 40801

    Prague, Czechia

  • Pa0016 40802

    Ostrava, Czechia

  • Pa0016 40803

    Sabadell, Spain

  • Pa0016 40804

    Budapest, Hungary

  • Pa0016 40805

    Wroclaw, Poland

  • Pa0016 40806

    A Coruña, Spain

  • Pa0016 40807

    Poznan, Poland

  • Pa0016 40808

    Cologne, Germany

  • Pa0016 40809

    Hódmezővásárhely, Hungary

  • Pa0016 40810

    Herne, Germany

  • Pa0016 40811

    Sofia, Bulgaria

  • Pa0016 40813

    Plovdiv, Bulgaria

  • Pa0016 40818

    Plovdiv, Bulgaria

  • Pa0016 40819

    Sofia, Bulgaria

  • Pa0016 40820

    Plovdiv, Bulgaria

  • Pa0016 40823

    Rousse, Bulgaria

  • Pa0016 40824

    Bialystok, Poland

  • Pa0016 40827

    Luton, United Kingdom

  • Pa0016 40828

    Reading, United Kingdom

  • Pa0016 40833

    Barnet, United Kingdom

  • Pa0016 50001

    Jackson, Tennessee, 38305, United States

  • Pa0016 50006

    Wyomissing, Pennsylvania, 19610, United States

  • Pa0016 50016

    St Louis, Missouri, 63141, United States

  • Pa0016 50041

    Québec, Canada

  • Pa0016 50044

    Trois-Rivières, Canada

  • Pa0016 50048

    Katy, Texas, 77449, United States

  • Pa0016 50058

    Phoenix, Arizona, 85032, United States

  • Pa0016 50059

    Ormond Beach, Florida, 32174, United States

  • Pa0016 50061

    Spokane Valley, Washington, 99216, United States

  • Pa0016 50062

    Glendale, Arizona, 85306, United States

  • Pa0016 50131

    Sun City, Arizona, 85351, United States

  • Pa0016 50324

    Plantation, Florida, 33324, United States

  • Pa0016 50551

    Saint Clair Shores, Michigan, 48081, United States

  • Pa0016 50630

    Clearwater, Florida, 33765, United States

  • Pa0016 50650

    Willowbrook, Illinois, 60527, United States

  • Pa0016 50651

    Skokie, Illinois, 60076, United States

  • Pa0016 50652

    Duncansville, Pennsylvania, 16635, United States

  • Pa0016 50653

    Albuquerque, New Mexico, 87102, United States

  • Pa0016 50654

    Covina, California, 91722, United States

  • Pa0016 50655

    Tomball, Texas, 77375, United States

  • Pa0016 50657

    Lubbock, Texas, 79424, United States

  • Pa0016 50662

    Gilbert, Arizona, 85297, United States

  • Pa0016 50663

    San Diego, California, 92128, United States

  • Pa0016 50664

    Middletown, Ohio, 45044, United States

  • Pa0016 50665

    Lansing, Michigan, 48910, United States

  • Pa0016 50666

    Brooklyn, New York, 11201, United States

  • Pa0016 50672

    Santa Monica, California, 90404, United States

  • Pa0016 50673

    Fort Worth, Texas, 76109, United States

  • Pa0016 50674

    Glendale, Wisconsin, 53217, United States

  • Pa0016 50678

    Zephyrhills, Florida, 33542, United States

  • Pa0016 50679

    Cutler Bay, Florida, 33189, United States

  • Pa0016 50680

    Vandalia, Ohio, 45377, United States

  • Pa0016 50682

    Kansas City, Missouri, 64111, United States

  • Pa0016 50685

    Fort Lauderdale, Florida, 33309, United States

  • Pa0016 50686

    Hagerstown, Maryland, 21740, United States

  • Pa0016 50689

    Eagan, Minnesota, 55123, United States

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