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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Bimekizumab, Ankylosing Spondylitis, AS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • As0009 30
  • AS0009 1
  • AS0009 6
  • As0009 156
  • As0009 151
  • As0009 155
  • As0009 150
  • As0009 101
  • As0009 205
  • As0009 207
  • As0009 208
  • As0009 210
  • As0009 211
  • As0009 201
  • As0009 202
  • As0009 203
  • As0009 304
  • As0009 301
  • As0009 400
  • As0009 403
  • As0009 401
  • As0009 466
  • As0009 453
  • As0009 456
  • As0009 455
  • As0009 461
  • As0009 467
  • As0009 451
  • As0009 450
  • As0009 454
  • As0009 459
  • As0009 457
  • As0009 460
  • As0009 465
  • As0009 601
  • As0009 604
  • As0009 607
  • As0009 600
  • As0009 606
  • As0009 608
  • As0009 610
  • As0009 801
  • As0009 800
  • As0009 803
  • As0009 700
  • As0009 707
  • As0009 705
  • As0009 708
  • As0009 706
  • As0009 704

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bimekizumab

Arm Description

Subjects will receive bimekizumab up to 4 years.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs) during the study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Incidence of serious adverse event (SAE) during the study
Once it is determined that a subject experienced an Adverse Event (AE), the seriousness of the AE must be determined. An SAE must meet 1 or more of the following criteria: death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.

Secondary Outcome Measures

Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008
ASAS40 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are 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) in at least 3 of the 4 domains and no worsening at all in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity (PGADA) Pain assessment (the total spinal pain, NRS score) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008
ASAS20 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain. The domains are: Patient's Global Assessment of Disease Activity (PGADA) Pain assessment (the total spinal pain, NRS score) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
The Bath ankylosing spondylitis disease activity index (BASDAI) is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

Full Information

First Posted
November 22, 2017
Last Updated
October 18, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03355573
Brief Title
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Acronym
BE AGILE 2
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Bimekizumab, Ankylosing Spondylitis, AS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimekizumab
Arm Type
Experimental
Arm Description
Subjects will receive bimekizumab up to 4 years.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Bimekizumab at a prespecified dose.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) during the study
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Time Frame
From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Title
Incidence of serious adverse event (SAE) during the study
Description
Once it is determined that a subject experienced an Adverse Event (AE), the seriousness of the AE must be determined. An SAE must meet 1 or more of the following criteria: death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.
Time Frame
From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Secondary Outcome Measure Information:
Title
Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Time Frame
From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Title
Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008
Description
ASAS40 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are 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) in at least 3 of the 4 domains and no worsening at all in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity (PGADA) Pain assessment (the total spinal pain, NRS score) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Time Frame
Baseline of AS0008, Week 48
Title
Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008
Description
ASAS20 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain. The domains are: Patient's Global Assessment of Disease Activity (PGADA) Pain assessment (the total spinal pain, NRS score) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Time Frame
Baseline of AS0008, Week 48
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
Description
The Bath ankylosing spondylitis disease activity index (BASDAI) is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
Time Frame
Baseline of AS0008, Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
As0009 30
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
AS0009 1
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
AS0009 6
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
As0009 156
City
Dobrich
Country
Bulgaria
Facility Name
As0009 151
City
Plovdiv
Country
Bulgaria
Facility Name
As0009 155
City
Plovdiv
Country
Bulgaria
Facility Name
As0009 150
City
Ruse
Country
Bulgaria
Facility Name
As0009 101
City
Quebec City
Country
Canada
Facility Name
As0009 205
City
Brno
Country
Czechia
Facility Name
As0009 207
City
Olomouc
Country
Czechia
Facility Name
As0009 208
City
Pardubice
Country
Czechia
Facility Name
As0009 210
City
Praha 11 Chodov
Country
Czechia
Facility Name
As0009 211
City
Praha 3
Country
Czechia
Facility Name
As0009 201
City
Praha 4
Country
Czechia
Facility Name
As0009 202
City
Praha
Country
Czechia
Facility Name
As0009 203
City
Zlin
Country
Czechia
Facility Name
As0009 304
City
Hamburg
Country
Germany
Facility Name
As0009 301
City
Ratingen
Country
Germany
Facility Name
As0009 400
City
Budapest
Country
Hungary
Facility Name
As0009 403
City
Budapest
Country
Hungary
Facility Name
As0009 401
City
Veszprem
Country
Hungary
Facility Name
As0009 466
City
Bydgoszcz
Country
Poland
Facility Name
As0009 453
City
Elblag
Country
Poland
Facility Name
As0009 456
City
Elblag
Country
Poland
Facility Name
As0009 455
City
Krakow
Country
Poland
Facility Name
As0009 461
City
Lublin
Country
Poland
Facility Name
As0009 467
City
Nowa Sol
Country
Poland
Facility Name
As0009 451
City
Poznan
Country
Poland
Facility Name
As0009 450
City
Torun
Country
Poland
Facility Name
As0009 454
City
Warszawa
Country
Poland
Facility Name
As0009 459
City
Warszawa
Country
Poland
Facility Name
As0009 457
City
Wroclaw
Country
Poland
Facility Name
As0009 460
City
Wroclaw
Country
Poland
Facility Name
As0009 465
City
Wroclaw
Country
Poland
Facility Name
As0009 601
City
Moscow
Country
Russian Federation
Facility Name
As0009 604
City
Moscow
Country
Russian Federation
Facility Name
As0009 607
City
Moscow
Country
Russian Federation
Facility Name
As0009 600
City
Saint Petersburg
Country
Russian Federation
Facility Name
As0009 606
City
Saint Petersburg
Country
Russian Federation
Facility Name
As0009 608
City
Saint Petersburg
Country
Russian Federation
Facility Name
As0009 610
City
Saint-petersburg
Country
Russian Federation
Facility Name
As0009 801
City
A Coruna
Country
Spain
Facility Name
As0009 800
City
Cordoba
Country
Spain
Facility Name
As0009 803
City
Santiago de Compostela
Country
Spain
Facility Name
As0009 700
City
Kyiv
Country
Ukraine
Facility Name
As0009 707
City
Kyiv
Country
Ukraine
Facility Name
As0009 705
City
Ternopil
Country
Ukraine
Facility Name
As0009 708
City
Uzhgorod
Country
Ukraine
Facility Name
As0009 706
City
Vinnytsia
Country
Ukraine
Facility Name
As0009 704
City
Zaporizhzhia
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35829672
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.
Results Reference
result
PubMed Identifier
35833532
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.
Results Reference
result

Learn more about this trial

A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

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