Clinical trial NCT03355573: A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: Bimekizumab
Ankylosing Spondylitis
AS
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 255
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 and tolerability of bimekizumab in subjects with ankylosing spondylitis


Eligibility criteria: Inclusion Criteria:

* In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
* Subject completed AS0008 without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active

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). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
* Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
* Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
timeFrame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
measure: Percentage of Participants With Serious Adverse Event (SAE) During the Study
timeFrame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
Secondary outcomes:
measure: Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study
timeFrame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
measure: Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008
timeFrame: Baseline of AS0008, Week 48 (AS0009)
measure: Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008
timeFrame: Baseline of AS0008, Week 48 (AS0009)
measure: Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48
timeFrame: Baseline of AS0008, Week 48 (AS0009)
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: As0009 30
state: Florida
city: Duncansville
country: United States
facility: AS0009 1
state: Pennsylvania
city: Dallas
country: United States
facility: AS0009 6
state: Texas
city: Dobrich
country: Bulgaria
facility: As0009 156
city: Plovdiv
country: Bulgaria
facility: As0009 151
city: Plovdiv
country: Bulgaria
facility: As0009 155
city: Ruse
country: Bulgaria
facility: As0009 150
city: Quebec City
country: Canada
facility: As0009 101
city: Brno
country: Czechia
facility: As0009 205
city: Olomouc
country: Czechia
facility: As0009 207
city: Pardubice
country: Czechia
facility: As0009 208
city: Praha 11 Chodov
country: Czechia
facility: As0009 210
city: Praha 3
country: Czechia
facility: As0009 211
city: Praha 4
country: Czechia
facility: As0009 201
city: Praha
country: Czechia
facility: As0009 202
city: Zlin
country: Czechia
facility: As0009 203
city: Hamburg
country: Germany
facility: As0009 304
city: Ratingen
country: Germany
facility: As0009 301
city: Budapest
country: Hungary
facility: As0009 400
city: Budapest
country: Hungary
facility: As0009 403
city: Veszprem
country: Hungary
facility: As0009 401
city: Bydgoszcz
country: Poland
facility: As0009 466
city: Elblag
country: Poland
facility: As0009 453
city: Elblag
country: Poland
facility: As0009 456
city: Krakow
country: Poland
facility: As0009 455
city: Lublin
country: Poland
facility: As0009 461
city: Nowa Sol
country: Poland
facility: As0009 467
city: Poznan
country: Poland
facility: As0009 451
city: Torun
country: Poland
facility: As0009 450
city: Warszawa
country: Poland
facility: As0009 454
city: Warszawa
country: Poland
facility: As0009 459
city: Wroclaw
country: Poland
facility: As0009 457
city: Wroclaw
country: Poland
facility: As0009 460
city: Wroclaw
country: Poland
facility: As0009 465
city: Moscow
country: Russian Federation
facility: As0009 601
city: Moscow
country: Russian Federation
facility: As0009 604
city: Moscow
country: Russian Federation
facility: As0009 607
city: Saint Petersburg
country: Russian Federation
facility: As0009 600
city: Saint Petersburg
country: Russian Federation
facility: As0009 606
city: Saint Petersburg
country: Russian Federation
facility: As0009 608
city: Saint-petersburg
country: Russian Federation
facility: As0009 610
city: A Coruna
country: Spain
facility: As0009 801
city: Cordoba
country: Spain
facility: As0009 800
city: Santiago de Compostela
country: Spain
facility: As0009 803
city: Kyiv
country: Ukraine
facility: As0009 700
city: Kyiv
country: Ukraine
facility: As0009 707
city: Ternopil
country: Ukraine
facility: As0009 705
city: Uzhgorod
country: Ukraine
facility: As0009 708
city: Vinnytsia
country: Ukraine
facility: As0009 706
city: Zaporizhzhia
country: Ukraine
facility: As0009 704
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Baraliakos X, Deodhar A, Dougados M, Gensler LS, Molto A, Ramiro S, Kivitz AJ, Poddubnyy D, Oortgiesen M, Vaux T, Fleurinck C, Shepherd-Smith J, de la Loge C, de Peyrecave N, van der Heijde D. Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. Arthritis Rheumatol. 2022 Dec;74(12):1943-1958. doi: 10.1002/art.42282. Epub 2022 Nov 7.
citation: Robinson PC, Machado PM, Haroon N, Gensler LS, Reveille JD, Taieb V, Vaux T, Fleurinck C, Oortgiesen M, de Peyrecave N, Deodhar A. Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study. ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14.
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.