A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis (BE AGILE 2)

A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Bimekizumab

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Dobrich, Bulgaria
    • As0009 156
  • Plovdiv, Bulgaria
    • As0009 151
  • Plovdiv, Bulgaria
    • As0009 155
  • Ruse, Bulgaria
    • As0009 150
• Canada
  • Quebec City, Canada
    • As0009 101
• Czechia
  • Brno, Czechia
    • As0009 205
  • Olomouc, Czechia
    • As0009 207
  • Pardubice, Czechia
    • As0009 208
  • Praha, Czechia
    • As0009 202
  • Praha 11 Chodov, Czechia
    • As0009 210
  • Praha 3, Czechia
    • As0009 211
  • Praha 4, Czechia
    • As0009 201
  • Zlin, Czechia
    • As0009 203
• Germany
  • Hamburg, Germany
    • As0009 304
  • Ratingen, Germany
    • As0009 301
• Hungary
  • Budapest, Hungary
    • As0009 400
  • Budapest, Hungary
    • As0009 403
  • Veszprem, Hungary
    • As0009 401
• Poland
  • Bydgoszcz, Poland
    • As0009 466
  • Elblag, Poland
    • As0009 453
  • Elblag, Poland
    • As0009 456
  • Krakow, Poland
    • As0009 455
  • Lublin, Poland
    • As0009 461
  • Nowa Sol, Poland
    • As0009 467
  • Poznan, Poland
    • As0009 451
  • Torun, Poland
    • As0009 450
  • Warszawa, Poland
    • As0009 454
  • Warszawa, Poland
    • As0009 459
  • Wroclaw, Poland
    • As0009 457
  • Wroclaw, Poland
    • As0009 460
  • Wroclaw, Poland
    • As0009 465
• Russian Federation
  • Moscow, Russian Federation
    • As0009 601
  • Moscow, Russian Federation
    • As0009 604
  • Moscow, Russian Federation
    • As0009 607
  • Saint Petersburg, Russian Federation
    • As0009 600
  • Saint Petersburg, Russian Federation
    • As0009 606
  • Saint Petersburg, Russian Federation
    • As0009 608
  • Saint-petersburg, Russian Federation
    • As0009 610
• Spain
  • A Coruna, Spain
    • As0009 801
  • Cordoba, Spain
    • As0009 800
  • Santiago de Compostela, Spain
    • As0009 803
• Ukraine
  • Kyiv, Ukraine
    • As0009 700
  • Kyiv, Ukraine
    • As0009 707
  • Ternopil, Ukraine
    • As0009 705
  • Uzhgorod, Ukraine
    • As0009 708
  • Vinnytsia, Ukraine
    • As0009 706
  • Zaporizhzhia, Ukraine
    • As0009 704
• United States
  • Florida
    • Sarasota, Florida, United States, 34239
      • As0009 30
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • AS0009 1
  • Texas
    • Dallas, Texas, United States, 75231
      • AS0009 6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimekizumab; Subjects will receive bimekizumab up to 4 years.	Drug: Bimekizumab; Bimekizumab at a prespecified dose.; Other Names: UCB4940

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.	From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
Percentage of Participants With Serious Adverse Event (SAE) During the Study	A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Is a congenital anomaly or birth defect 5) Is an infection that requires treatment with parenteral antibiotics 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.	From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study	An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.	From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008	The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA) (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.	Baseline of AS0008, Week 48 (AS0009)
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008	The ASAS20 response was defined as relative improvements of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (BASFI) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.	Baseline of AS0008, Week 48 (AS0009)
Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48	BASDAI is a validated self-reported instrument, which consisted of 6 questions to measure the disease activity of ankylosing spondylitis (AS) from the participant's perspective. It measured the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration). Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0=none to 10= very severe, where higher score indicated high disease activity. A negative value indicated improvement and a positive value indicated worsening.	Baseline of AS0008, Week 48 (AS0009)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Publications and helpful links

General Publications

• 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.
• 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.
• 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 Aug 23:ard-2024-225933. doi: 10.1136/ard-2024-225933. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Ankylosing Spondylitis; AS; Bimekizumab
• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: AS0009; 2017-001002-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes