Clinical trial NCT04436640: A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis
Official title: A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Axial Spondyloarthritis
Ankylosing Spondylitis
r-axSpa
Nr-axSpa
Keywords: AxSpa
Radiographic
Non-radiographic
AS
Bimekizumab
Axial spondyloarthritis
Ankylosing spondylitis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 508
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: The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).


Eligibility criteria: Inclusion Criteria:

* Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
* In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study
* Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)

Exclusion Criteria:

* Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP). Male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose
* Study participants who meet any withdrawal criteria in AS0010 or AS0011. For any study participant with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder study, the Medical Monitor must be consulted prior to the study participant's entry into AS0014
* Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated

Primary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
measure: Percentage of participants with serious adverse events (SAEs) during the study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
measure: Percentage of participants with with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study
timeFrame: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Secondary outcomes:
measure: Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
timeFrame: Week 28
measure: Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
timeFrame: Week 52
measure: Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
timeFrame: Week 112
measure: Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
timeFrame: Week 28
measure: Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
timeFrame: Week 52
measure: Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112
timeFrame: Week 112
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
measure: Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28
timeFrame: Week 28
measure: Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52
timeFrame: Week 52
measure: Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112
timeFrame: Week 112
measure: Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28
timeFrame: Week 28
measure: Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52
timeFrame: Week 52
measure: Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112
timeFrame: Week 112
measure: Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28
timeFrame: Week 28
measure: Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52
timeFrame: Week 52
measure: Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112
timeFrame: Week 112
measure: Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
measure: Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
measure: Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
measure: Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
measure: Change from Baseline in nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
measure: Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
measure: Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
measure: Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
measure: Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
measure: Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
measure: Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
measure: Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
measure: Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
measure: Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
measure: Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
timeFrame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Other outcomes:
Locations:
city: Glendale
country: United States
facility: As0014 50062
state: Arizona
city: Phoenix
country: United States
facility: As0014 50052
state: Arizona
city: Upland
country: United States
facility: As0014 50060
state: California
city: Ormond Beach
country: United States
facility: As0014 50059
state: Florida
city: Sarasota
country: United States
facility: As0014 50056
state: Florida
city: Hagerstown
country: United States
facility: As0014 50015
state: Maryland
city: Saint Louis
country: United States
facility: As0014 50016
state: Missouri
city: Portland
country: United States
facility: As0014 50055
state: Oregon
city: Duncansville
country: United States
facility: As0014 50020
state: Pennsylvania
city: Dallas
country: United States
facility: As0014 50057
state: Texas
city: Bruxelles
country: Belgium
facility: As0014 40004
city: Genk
country: Belgium
facility: As0014 40003
city: Gent
country: Belgium
facility: As0014 40001
city: Plovdiv
country: Bulgaria
facility: As0014 40006
city: Plovdiv
country: Bulgaria
facility: As0014 40007
city: Sofia
country: Bulgaria
facility: As0014 40005
city: Sofia
country: Bulgaria
facility: As0014 40008
city: Beijing
country: China
facility: As0014 20040
city: Chengdu
country: China
facility: As0014 20021
city: Guangzhou
country: China
facility: As0014 20019
city: Hefei
country: China
facility: As0014 20034
city: Nanjing
country: China
facility: As0014 20024
city: Shanghai
country: China
facility: As0014 20018
city: Shanghai
country: China
facility: As0014 20020
city: Shanghai
country: China
facility: As0014 20026
city: Wenzhou
country: China
facility: As0014 20025
city: Brno
country: Czechia
facility: As0014 40011
city: Pardubice
country: Czechia
facility: As0014 40009
city: Praha 11
country: Czechia
facility: As0014 40013
city: Praha 2
country: Czechia
facility: As0014 40016
city: Praha 4
country: Czechia
facility: As0014 40014
city: Praha
country: Czechia
facility: As0014 40015
city: Uherske Hradiste
country: Czechia
facility: As0014 40010
city: Zlin
country: Czechia
facility: As0014 40012
city: Boulogne Billancourt
country: France
facility: As0014 40018
city: Limoges
country: France
facility: As0014 40022
city: Berlin
country: Germany
facility: As0014 40025
city: Hamburg
country: Germany
facility: As0014 40029
city: Hanover
country: Germany
facility: As0014 40024
city: Herne
country: Germany
facility: As0014 40027
city: Leipzig
country: Germany
facility: As0014 40078
city: Ratingen
country: Germany
facility: As0014 40026
city: Debrecen
country: Hungary
facility: As0014 40032
city: Szeged
country: Hungary
facility: As0014 40031
city: Székesfehérvár
country: Hungary
facility: As0014 40033
city: Bunkyo-ku
country: Japan
facility: As0014 20035
city: Chuo-ku
country: Japan
facility: As0014 20030
city: Iruma-gun
country: Japan
facility: As0014 20039
city: Kawachinagano
country: Japan
facility: As0014 20036
city: Kita-gun
country: Japan
facility: As0014 20045
city: Kitakyushu
country: Japan
facility: As0014 20065
city: Osaka
country: Japan
facility: As0014 20037
city: Saga
country: Japan
facility: As0014 20084
city: Saitama
country: Japan
facility: As0014 20048
city: Sapporo
country: Japan
facility: As0014 20031
city: Suita
country: Japan
facility: As0014 20032
city: Amsterdam
country: Netherlands
facility: As0014 40034
city: Elblag
country: Poland
facility: As0014 40038
city: Krakow
country: Poland
facility: As0014 40042
city: Lublin
country: Poland
facility: As0014 40037
city: Poznan
country: Poland
facility: As0014 40044
city: Torun
country: Poland
facility: As0014 40040
city: Warszawa
country: Poland
facility: As0014 40041
city: Wroclaw
country: Poland
facility: As0014 40039
city: Wroclaw
country: Poland
facility: As0014 40043
city: A Coruna
country: Spain
facility: As0014 40045
city: Cordoba
country: Spain
facility: As0014 40046
city: Santiago de Compostela
country: Spain
facility: As0014 40048
city: Sevilla
country: Spain
facility: As0014 40049
city: Ankara
country: Turkey
facility: As0014 40052
city: Ankara
country: Turkey
facility: As0014 40053
city: Istanbul
country: Turkey
facility: As0014 40050
city: Edinburgh
country: United Kingdom
facility: As0014 40057
city: Leeds
country: United Kingdom
facility: As0014 40056
city: Norwich
country: United Kingdom
facility: As0014 40055
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.