Clinical trial NCT04009499: A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Official title: A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 1131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).


Eligibility criteria: Inclusion Criteria:

* In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
* Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Exclusion Criteria:

* Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
* Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
* Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) during the study
timeFrame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
measure: Incidence of treatment-emergent serious adverse events (SAEs) during the study
timeFrame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
Secondary outcomes:
measure: TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study
timeFrame: From PA0012 Entry Visit until Safety Follow-Up (up to Week 212)
measure: American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
measure: Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 24 in PA0012
measure: Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 52 in PA0012
measure: Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011
timeFrame: Baseline of PA0010 or PA0011, Week 140 in PA0012
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pa0012 50017
state: Arizona
city: San Diego
country: United States
facility: Pa0012 50035
state: California
city: Palm Harbor
country: United States
facility: Pa0012 50033
state: Florida
city: Tampa
country: United States
facility: Pa0012 50037
state: Florida
city: Atlanta
country: United States
facility: Pa0012 50039
state: Georgia
city: Boise
country: United States
facility: Pa0012 50024
state: Idaho
city: Lexington
country: United States
facility: Pa0012 50028
state: Kentucky
city: Baton Rouge
country: United States
facility: Pa0012 50023
state: Louisiana
city: Hagerstown
country: United States
facility: Pa0012 50015
state: Maryland
city: Wheaton
country: United States
facility: Pa0012 50026
state: Maryland
city: Boston
country: United States
facility: Pa0012 50047
state: Massachusetts
city: Lansing
country: United States
facility: Pa0012 50019
state: Michigan
city: Saint Louis
country: United States
facility: Pa0012 50016
state: Missouri
city: Freehold
country: United States
facility: Pa0012 50005
state: New Jersey
city: Albuquerque
country: United States
facility: Pa0012 50029
state: New Mexico
city: Brooklyn
country: United States
facility: Pa0012 50010
state: New York
city: New York
country: United States
facility: Pa0012 50011
state: New York
city: Rochester
country: United States
facility: Pa0012 50034
state: New York
city: Charlotte
country: United States
facility: Pa0012 50125
state: North Carolina
city: Salisbury
country: United States
facility: Pa0012 50031
state: North Carolina
city: Vandalia
country: United States
facility: Pa0012 50040
state: Ohio
city: Duncansville
country: United States
facility: Pa0012 50020
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pa0012 50006
state: Pennsylvania
city: Johnston
country: United States
facility: Pa0012 50008
state: Rhode Island
city: Orangeburg
country: United States
facility: Pa0012 50007
state: South Carolina
city: Jackson
country: United States
facility: Pa0012 50001
state: Tennessee
city: Memphis
country: United States
facility: Pa0012 50012
state: Tennessee
city: Austin
country: United States
facility: Pa0012 50002
state: Texas
city: Corpus Christi
country: United States
facility: Pa0012 50049
state: Texas
city: Mesquite
country: United States
facility: Pa0012 50036
state: Texas
city: Waco
country: United States
facility: Pa0012 50009
state: Texas
city: Beckley
country: United States
facility: Pa0012 50050
state: West Virginia
city: Camberwell
country: Australia
facility: Pa0012 30005
city: Clayton
country: Australia
facility: Pa0012 30002
city: Hobart
country: Australia
facility: Pa0012 30008
city: Maroochydore
country: Australia
facility: Pa0012 30003
city: Victoria Park
country: Australia
facility: Pa0012 30007
city: Woodville South
country: Australia
facility: Pa0012 30006
city: Genk
country: Belgium
facility: Pa0012 40003
city: Leuven
country: Belgium
facility: Pa0012 40002
city: Mons
country: Belgium
facility: Pa0012 40059
city: Quebec
country: Canada
facility: Pa0012 50041
city: Rimouski
country: Canada
facility: Pa0012 50042
city: Sydney
country: Canada
facility: Pa0012 50043
city: Trois-rivieres
country: Canada
facility: Pa0012 50044
city: Brno
country: Czechia
facility: Pa0012 40061
city: Brno
country: Czechia
facility: Pa0012 40065
city: Ostrava
country: Czechia
facility: Pa0012 40062
city: Pardubice
country: Czechia
facility: Pa0012 40009
city: Praha 11
country: Czechia
facility: Pa0012 40013
city: Praha 2
country: Czechia
facility: Pa0012 40066
city: Praha 4
country: Czechia
facility: Pa0012 40014
city: Praha 5
country: Czechia
facility: Pa0012 40063
city: Praha
country: Czechia
facility: Pa0012 40015
city: Uherske Hradiste
country: Czechia
facility: Pa0012 40010
city: Zlin
country: Czechia
facility: Pa0012 40012
city: Chambray Les Tours
country: France
facility: Pa0012 40068
city: Paris
country: France
facility: Pa0012 40019
city: Bad Doberan
country: Germany
facility: Pa0012 40074
city: Berlin
country: Germany
facility: Pa0012 40025
city: Cottbus
country: Germany
facility: Pa0012 40076
city: Erlangen
country: Germany
facility: Pa0012 40023
city: Frankfurt
country: Germany
facility: Pa0012 40117
city: Hamburg
country: Germany
facility: Pa0012 40029
city: Hamburg
country: Germany
facility: Pa0012 40071
city: Herne
country: Germany
facility: Pa0012 40027
city: Leipzig
country: Germany
facility: Pa0012 40078
city: Ratingen
country: Germany
facility: Pa0012 40026
city: Budapest
country: Hungary
facility: Pa0012 40081
city: Budapest
country: Hungary
facility: Pa0012 40083
city: Debrecen
country: Hungary
facility: Pa0012 40032
city: Eger
country: Hungary
facility: Pa0012 40030
city: Kistarcsa
country: Hungary
facility: Pa0012 40082
city: Szentes
country: Hungary
facility: Pa0012 40079
city: Székesfehérvár
country: Hungary
facility: Pa0012 40033
city: Catania
country: Italy
facility: Pa0012 40084
city: Milano
country: Italy
facility: Pa0012 40087
city: Reggio Emilia
country: Italy
facility: Pa0012 40086
city: Bunkyo-ku
country: Japan
facility: Pa0012 20035
city: Chuo-ku
country: Japan
facility: Pa0012 20030
city: Itabashi-ku
country: Japan
facility: Pa0012 20043
city: Kawachinagano
country: Japan
facility: Pa0012 20036
city: Kita-gun
country: Japan
facility: Pa0012 20045
city: Kitakyushu
country: Japan
facility: Pa0012 20049
city: Minato-ku
country: Japan
facility: Pa0012 20044
city: Nagoya
country: Japan
facility: Pa0012 20033
city: Osaka
country: Japan
facility: Pa0012 20041
city: Osaka
country: Japan
facility: Pa0012 20046
city: Saitama
country: Japan
facility: Pa0012 20048
city: Sapporo
country: Japan
facility: Pa0012 20031
city: Sasebo
country: Japan
facility: Pa0012 20042
city: Suita
country: Japan
facility: Pa0012 20032
city: Bialystok
country: Poland
facility: Pa0012 40093
city: Bydgoszcz
country: Poland
facility: Pa0012 40119
city: Elblag
country: Poland
facility: Pa0012 40038
city: Elblag
country: Poland
facility: Pa0012 40088
city: Gdynia
country: Poland
facility: Pa0012 40096
city: Krakow
country: Poland
facility: Pa0012 40042
city: Kraków
country: Poland
facility: Pa0012 40092
city: Lublin
country: Poland
facility: Pa0012 40037
city: Nowa Sól
country: Poland
facility: Pa0012 40091
city: Poznan
country: Poland
facility: Pa0012 40044
city: Poznan
country: Poland
facility: Pa0012 40090
city: Warsaw
country: Poland
facility: Pa0012 40118
city: Warszawa
country: Poland
facility: Pa0012 40041
city: Warszawa
country: Poland
facility: Pa0012 40094
city: Warszawa
country: Poland
facility: Pa0012 40097
city: Warszawa
country: Poland
facility: Pa0012 40098
city: Wroclaw
country: Poland
facility: Pa0012 40039
city: Wroclaw
country: Poland
facility: Pa0012 40043
city: Wroclaw
country: Poland
facility: Pa0012 40095
city: Moscow
country: Russian Federation
facility: Pa0012 20002
city: Moscow
country: Russian Federation
facility: Pa0012 20005
city: Moscow
country: Russian Federation
facility: Pa0012 20010
city: Moscow
country: Russian Federation
facility: Pa0012 20017
city: Petrozavodsk
country: Russian Federation
facility: Pa0012 20013
city: Ryazan
country: Russian Federation
facility: Pa0012 20012
city: Ryazan
country: Russian Federation
facility: Pa0012 20016
city: Saint Petersburg
country: Russian Federation
facility: Pa0012 20004
city: Saint-petersburg
country: Russian Federation
facility: Pa0012 20001
city: Saint-petersburg
country: Russian Federation
facility: Pa0012 20003
city: Saint-petersburg
country: Russian Federation
facility: Pa0012 20009
city: Saint-petersburg
country: Russian Federation
facility: Pa0012 20083
city: Saratov
country: Russian Federation
facility: Pa0012 20007
city: Ulyanovsk
country: Russian Federation
facility: Pa0012 20014
city: Vladimir
country: Russian Federation
facility: Pa0012 20006
city: Yaroslavl
country: Russian Federation
facility: Pa0012 20008
city: Yaroslavl
country: Russian Federation
facility: Pa0012 20015
city: A Coruna
country: Spain
facility: Pa0012 40045
city: Cordoba
country: Spain
facility: Pa0012 40105
city: Málaga
country: Spain
facility: Pa0012 40102
city: Sabadell
country: Spain
facility: Pa0012 40101
city: Santiago de Compostela
country: Spain
facility: Pa0012 40104
city: Sevilla
country: Spain
facility: Pa0012 40049
city: Sevilla
country: Spain
facility: Pa0012 40106
city: Vigo
country: Spain
facility: Pa0012 40099
city: Oxford
country: United Kingdom
facility: Pa0012 40109
city: Peterborough
country: United Kingdom
facility: Pa0012 40116
city: Wolverhampton
country: United Kingdom
facility: Pa0012 40107
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.
citation: Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 Sep 1;63(9):2399-2410. doi: 10.1093/rheumatology/keae277.
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.
citation: Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2025 May 10. doi: 10.1007/s40744-025-00764-8. Online ahead of print.