Clinical trial NCT03895203: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 852
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: This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).


Eligibility criteria: Inclusion Criteria:

* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
* Subject is male or female at least 18 years of age
* Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
* Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) \>=3 out of 68 and swollen joint count (SJC) \>=3 out of 66
* Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
* Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
* Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
* Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

Exclusion Criteria:

* Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
* Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
* Subject has an active infection or a history of recent serious infections
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
* Subject had acute anterior uveitis within 6 weeks of Baseline
* Subject 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
* Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
* Presence of active suicidal ideation, or moderately severe major depression or severe major depression
* Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ
timeFrame: Baseline, Week 16
measure: Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline
timeFrame: Baseline, Week 4
measure: Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ
timeFrame: Baseline, Week 16
measure: Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ
timeFrame: Baseline, Week 16
measure: Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011
timeFrame: Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
measure: Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011
timeFrame: Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in the Overall Population at Week 16 for Placebo and BKZ
timeFrame: Baseline, Week 16
measure: Percentage of Participants With an American College of Rheumatology (ACR) 70 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) AND at Least a 2-grade Reduction From Baseline at Week 4 in the Subset of Participants With Psoriatic Skin Lesions at Baseline
timeFrame: Baseline, Week 4
measure: Percentage of Participants With an IGA Response Defined as Score of 0 (Clear) or 1 (Almost Clear) AND at Least a 2-grade Reduction From Baseline at Week 16 in the Subset of Participants With Psoriatic Skin Lesions at Baseline
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With an Enthesitis-free State Based on the Spondyloarthritis Research Consortium of Canada (SPARCC) Index at Week 16 in the Subgroup of Participants With Enthesitis at Baseline
timeFrame: Baseline, Week 16
measure: Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Baseline until Safety Follow-Up (up to Week 72)
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
timeFrame: From Baseline until Safety Follow-Up (up to Week 72)
measure: Percentage of Participants With TEAEs Leading to Withdrawal From IMP During the Study
timeFrame: From Baseline until Safety Follow-Up (up to Week 72)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pa0010 50017
state: Arizona
city: San Diego
country: United States
facility: Pa0010 50035
state: California
city: Tustin
country: United States
facility: Pa0010 50004
state: California
city: Palm Harbor
country: United States
facility: Pa0010 50033
state: Florida
city: Tampa
country: United States
facility: Pa0010 50037
state: Florida
city: Atlanta
country: United States
facility: Pa0010 50039
state: Georgia
city: Lexington
country: United States
facility: Pa0010 50028
state: Kentucky
city: Hagerstown
country: United States
facility: Pa0010 50015
state: Maryland
city: Saint Louis
country: United States
facility: Pa0010 50016
state: Missouri
city: Albuquerque
country: United States
facility: Pa0010 50029
state: New Mexico
city: Brooklyn
country: United States
facility: Pa0010 50010
state: New York
city: Charlotte
country: United States
facility: Pa0010 50125
state: North Carolina
city: Dayton
country: United States
facility: Pa0010 50040
state: Ohio
city: Duncansville
country: United States
facility: Pa0010 50020
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pa0010 50006
state: Pennsylvania
city: Johnston
country: United States
facility: Pa0010 50008
state: Rhode Island
city: Orangeburg
country: United States
facility: Pa0010 50007
state: South Carolina
city: Jackson
country: United States
facility: Pa0010 50001
state: Tennessee
city: Memphis
country: United States
facility: Pa0010 50012
state: Tennessee
city: Austin
country: United States
facility: Pa0010 50002
state: Texas
city: Corpus Christi
country: United States
facility: Pa0010 50049
state: Texas
city: Houston
country: United States
facility: Pa0010 50051
state: Texas
city: Mesquite
country: United States
facility: Pa0010 50036
state: Texas
city: Waco
country: United States
facility: Pa0010 50009
state: Texas
city: Beckley
country: United States
facility: Pa0010 50050
state: West Virginia
city: Camberwell
country: Australia
facility: Pa0010 30005
city: Clayton
country: Australia
facility: Pa0010 30002
city: Hobart
country: Australia
facility: Pa0010 30008
city: Maroochydore
country: Australia
facility: Pa0010 30003
city: Victoria Park
country: Australia
facility: Pa0010 30007
city: Woodville
country: Australia
facility: Pa0010 30006
city: Genk
country: Belgium
facility: Pa0010 40003
city: Leuven
country: Belgium
facility: Pa0010 40002
city: Mons
country: Belgium
facility: Pa0010 40059
city: Québec City
country: Canada
facility: Pa0010 50041
city: Rimouski
country: Canada
facility: Pa0010 50042
city: Sidney
country: Canada
facility: Pa0010 50043
city: Trois-Rivières
country: Canada
facility: Pa0010 50044
city: Brno
country: Czechia
facility: Pa0010 40061
city: Brno
country: Czechia
facility: Pa0010 40065
city: Ostrava
country: Czechia
facility: Pa0010 40062
city: Pardubice
country: Czechia
facility: Pa0010 40009
city: Praha 11
country: Czechia
facility: Pa0010 40013
city: Praha 2
country: Czechia
facility: Pa0010 40066
city: Praha 4
country: Czechia
facility: Pa0010 40014
city: Praha 5
country: Czechia
facility: Pa0010 40063
city: Praha
country: Czechia
facility: Pa0010 40015
city: Uherské Hradiště
country: Czechia
facility: Pa0010 40010
city: Zlín
country: Czechia
facility: Pa0010 40012
city: Paris
country: France
facility: Pa0010 40019
city: Tours
country: France
facility: Pa0010 40068
city: Bad Doberan
country: Germany
facility: Pa0010 40074
city: Berlin
country: Germany
facility: Pa0010 40025
city: Berlin
country: Germany
facility: Pa0010 40028
city: Cottbus
country: Germany
facility: Pa0010 40076
city: Erlangen
country: Germany
facility: Pa0010 40023
city: Frankfurt
country: Germany
facility: Pa0010 40117
city: Hamburg
country: Germany
facility: Pa0010 40029
city: Hamburg
country: Germany
facility: Pa0010 40071
city: Herne
country: Germany
facility: Pa0010 40027
city: Leipzig
country: Germany
facility: Pa0010 40078
city: Magdeburg
country: Germany
facility: Pa0010 40348
city: Ratingen
country: Germany
facility: Pa0010 40026
city: Budapest
country: Hungary
facility: Pa0010 40081
city: Budapest
country: Hungary
facility: Pa0010 40083
city: Debrecen
country: Hungary
facility: Pa0010 40032
city: Eger
country: Hungary
facility: Pa0010 40030
city: Kistarcsa
country: Hungary
facility: Pa0010 40082
city: Szentes
country: Hungary
facility: Pa0010 40079
city: Szombathely
country: Hungary
facility: Pa0010 40080
city: Székesfehérvár
country: Hungary
facility: Pa0010 40033
city: Catania
country: Italy
facility: Pa0010 40084
city: Milano
country: Italy
facility: Pa0010 40087
city: Pisa
country: Italy
facility: Pa0010 40085
city: Reggio Emilia
country: Italy
facility: Pa0010 40086
city: Bunkyō-Ku
country: Japan
facility: Pa0010 20035
city: Itabashi
country: Japan
facility: Pa0010 20043
city: Kawachi-Nagano-shi
country: Japan
facility: Pa0010 20036
city: Kitakyushu
country: Japan
facility: Pa0010 20049
city: Kita
country: Japan
facility: Pa0010 20045
city: Minato-Ku
country: Japan
facility: Pa0010 20044
city: Nagoya
country: Japan
facility: Pa0010 20033
city: Osaka
country: Japan
facility: Pa0010 20041
city: Osaka
country: Japan
facility: Pa0010 20046
city: Saitama
country: Japan
facility: Pa0010 20048
city: Sapporo-City
country: Japan
facility: Pa0010 20031
city: Sasebo
country: Japan
facility: Pa0010 20042
city: Suita
country: Japan
facility: Pa0010 20032
city: Tokyo
country: Japan
facility: Pa0010 20030
city: Białystok
country: Poland
facility: Pa0010 40093
city: Bydgoszcz
country: Poland
facility: Pa0010 40119
city: Elbląg
country: Poland
facility: Pa0010 40038
city: Elbląg
country: Poland
facility: Pa0010 40088
city: Gdynia
country: Poland
facility: Pa0010 40096
city: Kraków
country: Poland
facility: Pa0010 40042
city: Kraków
country: Poland
facility: Pa0010 40092
city: Lublin
country: Poland
facility: Pa0010 40037
city: Nowa Sól
country: Poland
facility: Pa0010 40091
city: Poznań
country: Poland
facility: Pa0010 40044
city: Poznań
country: Poland
facility: Pa0010 40090
city: Toruń
country: Poland
facility: Pa0010 40118
city: Warszawa
country: Poland
facility: Pa0010 40041
city: Warszawa
country: Poland
facility: Pa0010 40094
city: Warszawa
country: Poland
facility: Pa0010 40097
city: Warszawa
country: Poland
facility: Pa0010 40098
city: Wrocław
country: Poland
facility: Pa0010 40039
city: Wrocław
country: Poland
facility: Pa0010 40043
city: Wrocław
country: Poland
facility: Pa0010 40095
city: Moscow
country: Russian Federation
facility: Pa0010 20002
city: Moscow
country: Russian Federation
facility: Pa0010 20005
city: Moscow
country: Russian Federation
facility: Pa0010 20010
city: Moscow
country: Russian Federation
facility: Pa0010 20017
city: Petrozavodsk
country: Russian Federation
facility: Pa0010 20013
city: Ryazan'
country: Russian Federation
facility: Pa0010 20012
city: Ryazan'
country: Russian Federation
facility: Pa0010 20016
city: Saint Petersburg
country: Russian Federation
facility: Pa0010 20001
city: Saint Petersburg
country: Russian Federation
facility: Pa0010 20003
city: Saint Petersburg
country: Russian Federation
facility: Pa0010 20004
city: Saint Petersburg
country: Russian Federation
facility: Pa0010 20009
city: Saint Petersburg
country: Russian Federation
facility: Pa0010 20083
city: Saratov
country: Russian Federation
facility: Pa0010 20007
city: Ulyanovsk
country: Russian Federation
facility: Pa0010 20014
city: Vladimir
country: Russian Federation
facility: Pa0010 20006
city: Yaroslavl
country: Russian Federation
facility: Pa0010 20008
city: Yaroslavl
country: Russian Federation
facility: Pa0010 20015
city: Coruña
country: Spain
facility: Pa0010 40045
city: Córdoba
country: Spain
facility: Pa0010 40105
city: Málaga
country: Spain
facility: Pa0010 40102
city: Sabadell
country: Spain
facility: Pa0010 40101
city: Santiago De Compostela
country: Spain
facility: Pa0010 40104
city: Sevilla
country: Spain
facility: Pa0010 40049
city: Sevilla
country: Spain
facility: Pa0010 40103
city: Sevilla
country: Spain
facility: Pa0010 40106
city: Vigo
country: Spain
facility: Pa0010 40099
city: Leeds
country: United Kingdom
facility: Pa0010 40111
city: Wolverhampton
country: United Kingdom
facility: Pa0010 40107
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Ritchlin CT, Coates LC, McInnes IB, Mease PJ, Merola JF, Tanaka Y, Asahina A, Gossec L, Gottlieb AB, Warren RB, Ink B, Bajracharya R, Shende V, Coarse J, Landewe RB. Bimekizumab treatment in biologic DMARD-naive patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023 Nov;82(11):1404-1414. doi: 10.1136/ard-2023-224431. Epub 2023 Sep 11.
citation: Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
citation: Kristensen LE, Tillett W, Nash P, Coates LC, Mease PJ, Ogdie A, Gisondi P, Ink B, Prickett AR, Bajracharya R, Taieb V, Lyris N, Lambert J, Walsh JA. Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies. Ther Adv Musculoskelet Dis. 2024 Nov 11;16:1759720X241288071. doi: 10.1177/1759720X241288071. eCollection 2024.