A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
- Conditions
- Psoriatic Arthritis
- Interventions
- Registration Number
- NCT06624228
- Lead Sponsor
- UCB Biopharma SRL
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimekizumab Bimekizumab Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period. Bimekizumab Placebo Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period. Risankizumab Placebo Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period. Risankizumab Risankizumab Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.
- Primary Outcome Measures
Name Time Method American College of Rheumatology 50 (ACR50) at Week 16 Week 16 The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
* TJC and SJC: 2-point scale (0=absent;1=present) • Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms;100=very poor, severe symptoms)
* Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • Patient's Assessment of Arthritis Pain (PtAAP): 100 VAS (0=no pain;100=most severe pain).
* Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability.
* High sensitivity C-reactive protein (hs-CRP) in mg/L
- Secondary Outcome Measures
Name Time Method Minimal Disease Activity (MDA) at Week 16 Week 16 A study participant is considered as having MDA if 5 or more of the following 7 criteria are fulfilled:
* Tender joint count ≤1
* Swollen joint count ≤1
* PASI ≤1 or BSA ≤3
* PtAAP VAS ≤15
* PGA-PsA VAS ≤20
* HAQ-DI ≤0.5
* Tender enthesial points ≤1Percentage of participants reaching the composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline Week 16 The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
The PASI100 response is based on at least 100% improvement in the PASI score. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.Incidence of Participants With Treatment-emergent adverse events (TEAEs) From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks) An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Incidence of Participants With Treatment-emergent serious AEs From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks) A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
* Results in death
* Is life-threatening
* Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect
* Results in permanent or significant disability/incapacity
* Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the aboveIncidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP) From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks) An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
Trial Locations
- Locations (118)
Pa0016 40073
🇩🇪Bad Nauheim, Germany
Pa0016 40269
🇪🇸Bilbao, Spain
Pa0016 40138
🇩🇪Bonn, Germany
Pa0016 40808
🇩🇪Cologne, 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
🇭🇺Hodmezovasarhely, Hungary
Pa0016 40031
🇭🇺Szeged, Hungary
Pa0016 20035
🇯🇵Bunkyo-ku, Japan
Pa0016 20043
🇯🇵Itabashi-ku, Japan
Pa0016 20045
🇯🇵Kita-gun, Japan
Pa0016 20049
🇯🇵Kitakyushu, Japan
Pa0016 20069
🇯🇵Meguro-ku, Japan
Pa0016 20033
🇯🇵Nagoya, Japan
Pa0016 20041
🇯🇵Osaka, Japan
Pa0016 20046
🇯🇵Osaka, Japan
Pa0016 20031
🇯🇵Sapporo, Japan
Pa0016 20335
🇯🇵Yokohama, 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 40490
🇵🇱Krakow, Poland
Pa0016 40502
🇵🇱Krakow, Poland
Pa0016 40792
🇵🇱Krakow, Poland
Pa0016 40092
🇵🇱Kraków, 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 50655
🇺🇸Tomball, Texas, United States
Pa0016 40797
🇵🇱Warszawa, Poland
Pa0016 40807
🇵🇱Poznan, Poland
Pa0016 40043
🇵🇱Wroclaw, Poland
Pa0016 40095
🇵🇱Wroclaw, Poland
Pa0016 40805
🇵🇱Wroclaw, Poland
Pa0016 40806
🇪🇸A Coruna, Spain
Pa0016 40231
🇪🇸Madrid, Spain
Pa0016 40102
🇪🇸Málaga, Spain
Pa0016 50662
🇺🇸Gilbert, Arizona, United States
Pa0016 50062
🇺🇸Glendale, Arizona, United States
Pa0016 50058
🇺🇸Phoenix, Arizona, United States
Pa0016 50677
🇺🇸Scottsdale, 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 50239
🇺🇸Brandon, Florida, 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 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
🇺🇸Saint Louis, Missouri, United States
Pa0016 50653
🇺🇸Albuquerque, New Mexico, United States
Pa0016 50666
🇺🇸Brooklyn, New York, United States
Pa0016 50521
🇺🇸New York, 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 50048
🇺🇸Baytown, Texas, United States
Pa0016 50673
🇺🇸Fort Worth, Texas, United States
Pa0016 50657
🇺🇸Lubbock, Texas, United States
Pa0016 50061
🇺🇸Spokane, Washington, United States
Pa0016 50674
🇺🇸Glendale, Wisconsin, United States
Pa0016 30002
🇦🇺Clayton, Australia
Pa0016 30033
🇦🇺Heidelberg, Australia
Pa0016 30003
🇦🇺Maroochydore, Australia
Pa0016 30032
🇦🇺Parramatta, Australia
Pa0016 40313
🇧🇬Pleven, Bulgaria
Pa0016 40813
🇧🇬Plovdiv, Bulgaria
Pa0016 40820
🇧🇬Plovdiv, Bulgaria
Pa0016 40823
🇧🇬Ruse, Bulgaria
Pa0016 40656
🇧🇬Russe, Bulgaria
Pa0016 40314
🇧🇬Sofia, Bulgaria
Pa0016 40811
🇧🇬Sofia, Bulgaria
Pa0016 40819
🇧🇬Sofia, Bulgaria
Pa0016 50041
🇨🇦Quebec, Canada
Pa0016 50044
🇨🇦Trois-rivieres, Canada
Pa0016 40065
🇨🇿Brno, Czechia
Pa0016 40062
🇨🇿Ostrava, Czechia
Pa0016 40802
🇨🇿Ostrava, Czechia
Pa0016 40801
🇨🇿Praha 4, Czechia
Pa0016 40010
🇨🇿Uherske Hradiste, Czechia
Pa0016 40012
🇨🇿Zlin, Czechia
Pa0016 40025
🇩🇪Berlin, Germany
Pa0016 40515
🇩🇪Berlin, Germany
Pa0016 40790
🇵🇱Sochaczew, Poland
Pa0016 40788
🇵🇱Torun, Poland
Pa0016 40094
🇵🇱Warszawa, Poland
Pa0016 40394
🇵🇱Warszawa, Poland
Pa0016 40539
🇵🇱Warszawa, Poland
Pa0016 40604
🇵🇱Warszawa, Poland
Pa0016 40793
🇵🇱Warszawa, Poland
Pa0016 40753
🇪🇸Santiago de Compostela, Spain
Pa0016 40049
🇪🇸Sevilla, Spain
Pa0016 40799
🇪🇸Sevilla, Spain
Pa0016 40281
🇬🇧Leeds, United Kingdom
Pa0016 40828
🇬🇧Reading, United Kingdom