Clinical trial NCT06624228: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: bimekizumab
risankizumab
arthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: American College of Rheumatology 50 (ACR50) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Minimal Disease Activity (MDA) at Week 16
timeFrame: Week 16
measure: Percentage 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
timeFrame: Week 16
measure: Incidence of Participants With Treatment-emergent adverse events (TEAEs)
timeFrame: From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
measure: Incidence of Participants With Treatment-emergent serious AEs
timeFrame: From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
measure: Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP)
timeFrame: From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Pa0016 50662
state: Arizona
city: Glendale
country: United States
facility: Pa0016 50062
state: Arizona
city: Phoenix
country: United States
facility: Pa0016 50058
state: Arizona
city: Scottsdale
country: United States
facility: Pa0016 50677
state: Arizona
city: Sun City
country: United States
facility: Pa0016 50131
state: Arizona
city: Covina
country: United States
facility: Pa0016 50654
state: California
city: La Jolla
country: United States
facility: Pa0016 50301
state: California
city: San Diego
country: United States
facility: Pa0016 50663
state: California
city: Santa Monica
country: United States
facility: Pa0016 50672
state: California
city: Brandon
country: United States
facility: Pa0016 50239
state: Florida
city: Clearwater
country: United States
facility: Pa0016 50630
state: Florida
city: Cutler Bay
country: United States
facility: Pa0016 50679
state: Florida
city: Fort Lauderdale
country: United States
facility: Pa0016 50685
state: Florida
city: Ormond Beach
country: United States
facility: Pa0016 50059
state: Florida
city: Plantation
country: United States
facility: Pa0016 50324
state: Florida
city: Zephyrhills
country: United States
facility: Pa0016 50678
state: Florida
city: Skokie
country: United States
facility: Pa0016 50651
state: Illinois
city: Willowbrook
country: United States
facility: Pa0016 50650
state: Illinois
city: Hagerstown
country: United States
facility: Pa0016 50686
state: Maryland
city: Lansing
country: United States
facility: Pa0016 50665
state: Michigan
city: Saint Clair Shores
country: United States
facility: Pa0016 50551
state: Michigan
city: Eagan
country: United States
facility: Pa0016 50689
state: Minnesota
city: Kansas City
country: United States
facility: Pa0016 50682
state: Missouri
city: Saint Louis
country: United States
facility: Pa0016 50016
state: Missouri
city: Albuquerque
country: United States
facility: Pa0016 50653
state: New Mexico
city: Brooklyn
country: United States
facility: Pa0016 50666
state: New York
city: New York
country: United States
facility: Pa0016 50521
state: New York
city: Middletown
country: United States
facility: Pa0016 50664
state: Ohio
city: Vandalia
country: United States
facility: Pa0016 50680
state: Ohio
city: Duncansville
country: United States
facility: Pa0016 50652
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pa0016 50006
state: Pennsylvania
city: Jackson
country: United States
facility: Pa0016 50001
state: Tennessee
city: Baytown
country: United States
facility: Pa0016 50048
state: Texas
city: Fort Worth
country: United States
facility: Pa0016 50673
state: Texas
city: Lubbock
country: United States
facility: Pa0016 50657
state: Texas
city: Tomball
country: United States
facility: Pa0016 50655
state: Texas
city: Spokane
country: United States
facility: Pa0016 50061
state: Washington
city: Glendale
country: United States
facility: Pa0016 50674
state: Wisconsin
city: Clayton
country: Australia
facility: Pa0016 30002
city: Footscray
country: Australia
facility: Pa0016 30034
city: Heidelberg
country: Australia
facility: Pa0016 30033
city: Maroochydore
country: Australia
facility: Pa0016 30003
city: Parramatta
country: Australia
facility: Pa0016 30032
city: Westmead
country: Australia
facility: Pa0016 30009
city: Pleven
country: Bulgaria
facility: Pa0016 40313
city: Plovdiv
country: Bulgaria
facility: Pa0016 40813
city: Plovdiv
country: Bulgaria
facility: Pa0016 40820
city: Ruse
country: Bulgaria
facility: Pa0016 40823
city: Russe
country: Bulgaria
facility: Pa0016 40656
city: Sofia
country: Bulgaria
facility: Pa0016 40314
city: Sofia
country: Bulgaria
facility: Pa0016 40811
city: Sofia
country: Bulgaria
facility: Pa0016 40819
city: Quebec
country: Canada
facility: Pa0016 50041
city: St. John's
country: Canada
facility: Pa0016 50658
city: Trois-rivieres
country: Canada
facility: Pa0016 50044
city: Brno
country: Czechia
facility: Pa0016 40065
city: Ostrava
country: Czechia
facility: Pa0016 40062
city: Ostrava
country: Czechia
facility: Pa0016 40802
city: Praha 2
country: Czechia
facility: Pa0016 40066
city: Praha 4
country: Czechia
facility: Pa0016 40801
city: Uherske Hradiste
country: Czechia
facility: Pa0016 40010
city: Zlin
country: Czechia
facility: Pa0016 40012
city: Bad Nauheim
country: Germany
facility: Pa0016 40073
city: Berlin
country: Germany
facility: Pa0016 40025
city: Berlin
country: Germany
facility: Pa0016 40515
city: Bonn
country: Germany
facility: Pa0016 40138
city: Cologne
country: Germany
facility: Pa0016 40808
city: Hamburg
country: Germany
facility: Pa0016 40029
city: Herne
country: Germany
facility: Pa0016 40810
city: München
country: Germany
facility: Pa0016 40724
city: Ratingen
country: Germany
facility: Pa0016 40800
city: Tuebingen
country: Germany
facility: Pa0016 40814
city: Budapest
country: Hungary
facility: Pa0016 40081
city: Budapest
country: Hungary
facility: Pa0016 40804
city: Hodmezovasarhely
country: Hungary
facility: Pa0016 40809
city: Szeged
country: Hungary
facility: Pa0016 40031
city: Bunkyo-ku
country: Japan
facility: Pa0016 20035
city: Itabashi-ku
country: Japan
facility: Pa0016 20043
city: Kita-gun
country: Japan
facility: Pa0016 20045
city: Kitakyushu
country: Japan
facility: Pa0016 20049
city: Meguro-ku
country: Japan
facility: Pa0016 20069
city: Mitaka-shi
country: Japan
facility: Pa0016 20336
city: Nagoya
country: Japan
facility: Pa0016 20033
city: Osaka
country: Japan
facility: Pa0016 20041
city: Osaka
country: Japan
facility: Pa0016 20046
city: Sapporo
country: Japan
facility: Pa0016 20031
city: Yokohama
country: Japan
facility: Pa0016 20335
city: Bialystok
country: Poland
facility: Pa0016 40789
city: Bialystok
country: Poland
facility: Pa0016 40791
city: Bialystok
country: Poland
facility: Pa0016 40824
city: Bydgoszcz
country: Poland
facility: Pa0016 40119
city: Bydgoszcz
country: Poland
facility: Pa0016 40798
city: Elblag
country: Poland
facility: Pa0016 40038
city: Katowice
country: Poland
facility: Pa0016 40795
city: Krakow
country: Poland
facility: Pa0016 40490
city: Krakow
country: Poland
facility: Pa0016 40502
city: Krakow
country: Poland
facility: Pa0016 40792
city: Kraków
country: Poland
facility: Pa0016 40092
city: Lublin
country: Poland
facility: Pa0016 40037
city: Nadarzyn
country: Poland
facility: Pa0016 40483
city: Nowa Sól
country: Poland
facility: Pa0016 40091
city: Olsztyn
country: Poland
facility: Pa0016 40796
city: Opole
country: Poland
facility: Pa0016 40794
city: Poznan
country: Poland
facility: Pa0016 40044
city: Poznan
country: Poland
facility: Pa0016 40090
city: Poznan
country: Poland
facility: Pa0016 40807
city: Sochaczew
country: Poland
facility: Pa0016 40790
city: Torun
country: Poland
facility: Pa0016 40788
city: Warszawa
country: Poland
facility: Pa0016 40094
city: Warszawa
country: Poland
facility: Pa0016 40394
city: Warszawa
country: Poland
facility: Pa0016 40539
city: Warszawa
country: Poland
facility: Pa0016 40604
city: Warszawa
country: Poland
facility: Pa0016 40793
city: Warszawa
country: Poland
facility: Pa0016 40797
city: Wroclaw
country: Poland
facility: Pa0016 40043
city: Wroclaw
country: Poland
facility: Pa0016 40095
city: Wroclaw
country: Poland
facility: Pa0016 40805
city: A Coruna
country: Spain
facility: Pa0016 40806
city: Bilbao
country: Spain
facility: Pa0016 40269
city: Madrid
country: Spain
facility: Pa0016 40231
city: Málaga
country: Spain
facility: Pa0016 40102
city: Sabadell
country: Spain
facility: Pa0016 40803
city: Santiago de Compostela
country: Spain
facility: Pa0016 40753
city: Sevilla
country: Spain
facility: Pa0016 40049
city: Sevilla
country: Spain
facility: Pa0016 40799
city: Barnet
country: United Kingdom
facility: Pa0016 40833
city: Leeds
country: United Kingdom
facility: Pa0016 40281
city: Luton
country: United Kingdom
facility: Pa0016 40827
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pa0016 40306
city: Peterborough
country: United Kingdom
facility: Pa0016 40812
city: Reading
country: United Kingdom
facility: Pa0016 40828
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: