ACTIVE_NOT_RECRUITING

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

Conditions

Psoriatic Arthritis bimekizumab risankizumab arthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-10-21

Study Completion:2026-07-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06624228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Principal Investigator

UCB Cares

STUDY_DIRECTOR

001 844 599 2273

Study Locations (Sites)

Pa0016 50662

Gilbert, Arizona, 85297

United States

Pa0016 50062

Glendale, Arizona, 85306

United States

Pa0016 50058

Phoenix, Arizona, 85032

United States

Pa0016 50131

Sun City, Arizona, 85351

United States

Pa0016 50654

Covina, California, 91722

United States

Pa0016 50301

La Jolla, California, 92037

United States

Pa0016 50663

San Diego, California, 92128

United States

Pa0016 50672

Santa Monica, California, 90404

United States

Pa0016 50239

Brandon, Florida, 33511

United States

Pa0016 50630

Clearwater, Florida, 33765

United States

Pa0016 50679

Cutler Bay, Florida, 33189

United States

Pa0016 50685

Fort Lauderdale, Florida, 33309

United States

Pa0016 50059

Ormond Beach, Florida, 32174

United States

Pa0016 50324

Plantation, Florida, 33324

United States

Pa0016 50678

Zephyrhills, Florida, 33542

United States

Pa0016 50651

Skokie, Illinois, 60076

United States

Pa0016 50650

Willowbrook, Illinois, 60527

United States

Pa0016 50686

Hagerstown, Maryland, 21740

United States

Pa0016 50665

Lansing, Michigan, 48910

United States

Pa0016 50551

Saint Clair Shores, Michigan, 48081

United States

Pa0016 50689

Eagan, Minnesota, 55121

United States

Pa0016 50682

Kansas City, Missouri, 64151

United States

Pa0016 50016

St Louis, Missouri, 63141

United States

Pa0016 50653

Albuquerque, New Mexico, 87102

United States

Pa0016 50666

Brooklyn, New York, 11201

United States

Pa0016 50664

Middletown, Ohio, 45044

United States

Pa0016 50680

Vandalia, Ohio, 45377

United States

Pa0016 50652

Duncansville, Pennsylvania, 16635

United States

Pa0016 50006

Wyomissing, Pennsylvania, 19610

United States

Pa0016 50001

Jackson, Tennessee, 38305

United States

Pa0016 50048

Baytown, Texas, 77521

United States

Pa0016 50687

Dallas, Texas, 75390

United States

Pa0016 50673

Fort Worth, Texas, 76109

United States

Pa0016 50657

Lubbock, Texas, 79424

United States

Pa0016 50655

Tomball, Texas, 77375

United States

Pa0016 50027

Seattle, Washington, 98104

United States

Pa0016 50061

Spokane, Washington, 99204

United States

Pa0016 50674

Glendale, Wisconsin, 53217

United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21

Study Completion Date2026-07-08

Study Record Updates

Study Start Date2024-10-21

Study Completion Date2026-07-08

Terms related to this study

Keywords Provided by Researchers

bimekizumab
risankizumab
arthritis

Additional Relevant MeSH Terms

Psoriatic Arthritis