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ACTIVE NOT RECRUITING

NCT06624228

PHASE3

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).

Official title: A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

684

Start Date

2024-10-21

Completion Date

2026-05-26

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Psoriatic Arthritis

Interventions

DRUG

Bimekizumab

Study participants will receive bimekizumab at pre-specified time points.

DRUG

Risankizumab

Study participants will receive risankizumab at pre-specified time points.

DRUG

Placebo

Study participants will receive placebo at pre-specified time points.

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. * 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.

Locations (127)

Pa0016 50662

Gilbert, Arizona, United States

Pa0016 50062

Glendale, Arizona, United States

Pa0016 50058

Phoenix, Arizona, United States

Pa0016 50131

Sun City, Arizona, United States

Pa0016 50654

Covina, California, United States

Pa0016 50663

San Diego, California, United States

Pa0016 50672

Santa Monica, California, United States

Pa0016 50630

Clearwater, Florida, United States

Pa0016 50679

Cutler Bay, Florida, United States

Pa0016 50685

Fort Lauderdale, Florida, United States

Pa0016 50059

Ormond Beach, Florida, United States

Pa0016 50324

Plantation, Florida, United States

Pa0016 50678

Zephyrhills, Florida, United States

Pa0016 50651

Skokie, Illinois, United States

Pa0016 50650

Willowbrook, Illinois, United States

Pa0016 50686

Hagerstown, Maryland, United States

Pa0016 50665

Lansing, Michigan, United States

Pa0016 50551

Saint Clair Shores, Michigan, United States

Pa0016 50689

Eagan, Minnesota, United States

Pa0016 50682

Kansas City, Missouri, United States

Pa0016 50016

St Louis, Missouri, United States

Pa0016 50653

Albuquerque, New Mexico, United States

Pa0016 50666

Brooklyn, New York, United States

Pa0016 50664

Middletown, Ohio, United States

Pa0016 50680

Vandalia, Ohio, United States

Pa0016 50652

Duncansville, Pennsylvania, United States

Pa0016 50006

Wyomissing, Pennsylvania, United States

Pa0016 50001

Jackson, Tennessee, United States

Pa0016 50673

Fort Worth, Texas, United States

Pa0016 50048

Katy, Texas, United States

Pa0016 50657

Lubbock, Texas, United States

Pa0016 50655

Tomball, Texas, United States

Pa0016 50061

Spokane Valley, Washington, United States

Pa0016 50674

Glendale, Wisconsin, United States

Pa0016 30002

Clayton, Australia

Pa0016 30034

Footscray, Australia

Pa0016 30033

Heidelberg, Australia

Pa0016 30003

Maroochydore, Australia

Pa0016 30032

Parramatta, Australia

Pa0016 30009

Westmead, Australia

Pa0016 40313

Pleven, Bulgaria

Pa0016 40006

Plovdiv, Bulgaria

Pa0016 40813

Plovdiv, Bulgaria

Pa0016 40818

Plovdiv, Bulgaria

Pa0016 40820

Plovdiv, Bulgaria

Pa0016 40656

Rousse, Bulgaria

Pa0016 40823

Rousse, Bulgaria

Pa0016 40314

Sofia, Bulgaria

Pa0016 40380

Sofia, Bulgaria

Pa0016 40811

Sofia, Bulgaria

Pa0016 40819

Sofia, Bulgaria

Pa0016 50041

Québec, Canada

Pa0016 50044

Trois-Rivières, Canada

Pa0016 40065

Brno, Czechia

Pa0016 40062

Moravska Ostrava A Privoz, Czechia

Pa0016 40802

Ostrava, Czechia

Pa0016 40066

Prague, Czechia

Pa0016 40801

Prague, Czechia

Pa0016 40010

Uherské Hradiště, Czechia

Pa0016 40012

Zlín, Czechia

Pa0016 40073

Bad Nauheim, Germany

Pa0016 40025

Berlin, Germany

Pa0016 40138

Bonn, Germany

Pa0016 40808

Cologne, Germany

Pa0016 40072

Freiburg im Breisgau, Germany

Pa0016 40029

Hamburg, Germany

Pa0016 40810

Herne, Germany

Pa0016 40724

München, Germany

Pa0016 40800

Ratingen, Germany

Pa0016 40081

Budapest, Hungary

Pa0016 40804

Budapest, Hungary

Pa0016 40809

Hódmezővásárhely, Hungary

Pa0016 40031

Szeged, Hungary

Pa0016 20035

Bunkyō City, Japan

Pa0016 20043

Itabashi-ku, Japan

Pa0016 20045

Kita-gun, Japan

Pa0016 20049

Kitakyushu, Japan

Pa0016 20069

Meguro-ku, Japan

Pa0016 20336

Mitaka-shi, Japan

Pa0016 20041

Osaka, Japan

Pa0016 20046

Osaka, Japan

Pa0016 20031

Sapporo, Japan

Pa0016 40789

Bialystok, Poland

Pa0016 40791

Bialystok, Poland

Pa0016 40824

Bialystok, Poland

Pa0016 40119

Bydgoszcz, Poland

Pa0016 40798

Bydgoszcz, Poland

Pa0016 40038

Elblag, Poland

Pa0016 40795

Katowice, Poland

Pa0016 40092

Krakow, Poland

Pa0016 40490

Krakow, Poland

Pa0016 40502

Krakow, Poland

Pa0016 40792

Krakow, Poland

Pa0016 40037

Lublin, Poland

Pa0016 40483

Nadarzyn, Poland

Pa0016 40091

Nowa Sól, Poland

Pa0016 40796

Olsztyn, Poland

Pa0016 40794

Opole, Poland

Pa0016 40044

Poznan, Poland

Pa0016 40090

Poznan, Poland

Pa0016 40807

Poznan, Poland

Pa0016 40790

Sochaczew, Poland

Pa0016 40788

Torun, Poland

Pa0016 40094

Warsaw, Poland

Pa0016 40394

Warsaw, Poland

Pa0016 40539

Warsaw, Poland

Pa0016 40604

Warsaw, Poland

Pa0016 40793

Warsaw, Poland

Pa0016 40797

Warsaw, Poland

Pa0016 40043

Wroclaw, Poland

Pa0016 40095

Wroclaw, Poland

Pa0016 40805

Wroclaw, Poland

Pa0016 40806

A Coruña, Spain

Pa0016 40269

Bilbao, Spain

Pa0016 40231

Madrid, Spain

Pa0016 40102

Málaga, Spain

Pa0016 40803

Sabadell, Spain

Pa0016 40753

Santiago de Compostela, Spain

Pa0016 40049

Seville, Spain

Pa0016 40799

Seville, Spain

Pa0016 40833

Barnet, United Kingdom

Pa0016 40281

Leeds, United Kingdom

Pa0016 40827

Luton, United Kingdom

Pa0016 40237

Manchester, United Kingdom

Pa0016 40306

Newcastle upon Tyne, United Kingdom

Pa0016 40828

Reading, United Kingdom

Pa0016 40108

Salford, United Kingdom

Clinical Research Directory

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (127)