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

October 18, 2023 updated by: UCB Biopharma SRL

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Incidence of treatment-emergent adverse events (TEAEs) during the study
Time Frame: From Entry Visit (Visit 1) until Last Visit (up to Week 208)
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.
From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Incidence of serious adverse event (SAE) during the study
Time Frame: From Entry Visit (Visit 1) until Last Visit (up to Week 208)
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.
From Entry Visit (Visit 1) until Last Visit (up to Week 208)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study
Time Frame: From Entry Visit (Visit 1) until Last Visit (up to Week 208)
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.
From Entry Visit (Visit 1) until Last Visit (up to Week 208)
Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008
Time Frame: Baseline of AS0008, Week 48

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))
Baseline of AS0008, Week 48
Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008
Time Frame: Baseline of AS0008, Week 48

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))
Baseline of AS0008, Week 48
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
Time Frame: Baseline of AS0008, 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.
Baseline of AS0008, Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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