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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bimekizumab 		Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.
  • Drug: Bimekizumab
    Study participants will receive bimekizumab at pre-specified time points.
  • Drug: Placebo
    Study participants will receive placebo at pre-specified time points.
Active Comparator
Risankizumab 		Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.
  • Drug: Risankizumab
    Study participants will receive risankizumab at pre-specified time points.
  • Drug: Placebo
    Study participants will receive placebo at pre-specified time points.

Recruiting Locations

Pa0016 50662
Gilbert, Arizona 85297

Pa0016 50062
Glendale, Arizona 85306

Pa0016 50058
Phoenix, Arizona 85032

Pa0016 50131
Sun City, Arizona 85351

Pa0016 50654
Covina, California 91722

Pa0016 50301
La Jolla, California 92037

Pa0016 50663
San Diego, California 92128

Pa0016 50672
Santa Monica, California 90404

Pa0016 50239
Brandon, Florida 33511

Pa0016 50630
Clearwater, Florida 33765

Pa0016 50679
Cutler Bay, Florida 33189

Pa0016 50685
Fort Lauderdale, Florida 33309

Pa0016 50059
Ormond Beach, Florida 32174

Pa0016 50324
Plantation, Florida 33324

Pa0016 50678
Zephyrhills, Florida 33542

Pa0016 50651
Skokie, Illinois 60076

Pa0016 50650
Willowbrook, Illinois 60527

Pa0016 50686
Hagerstown, Maryland 21740

Pa0016 50665
Lansing, Michigan 48910

Pa0016 50551
Saint Clair Shores, Michigan 48081

Pa0016 50689
Eagan, Minnesota 55121

Pa0016 50682
Kansas City, Missouri 64151

Pa0016 50016
Saint Louis, Missouri 63141

Pa0016 50653
Albuquerque, New Mexico 87102

Pa0016 50666
Brooklyn, New York 11201

Pa0016 50521
New York, New York 10003

Pa0016 50664
Middletown, Ohio 45044

Pa0016 50680
Vandalia, Ohio 45377

Pa0016 50652
Duncansville, Pennsylvania 16635

Pa0016 50006
Wyomissing, Pennsylvania 19610

Pa0016 50001
Jackson, Tennessee 38305

Pa0016 50048
Baytown, Texas 77521

Pa0016 50673
Fort Worth, Texas 76109

Pa0016 50657
Lubbock, Texas 79424

Pa0016 50655
Tomball, Texas 77375

Pa0016 50061
Spokane, Washington 99204

Pa0016 50674
Glendale, Wisconsin 53217

More Details

NCT ID
NCT06624228
Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
+18445992273
ucbcares@ucb.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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