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

Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03355573
Collaborator
(none)
256
Enrollment
50
Locations
1
Arm
58.5
Anticipated Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
256 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Actual Study Start Date :
Nov 28, 2017
Anticipated Primary Completion Date :
Oct 13, 2022
Anticipated Study Completion Date :
Oct 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bimekizumab

Subjects will receive bimekizumab up to 4 years.

Drug: Bimekizumab
Bimekizumab at a prespecified dose.
Other Names:
  • UCB4940

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events (TEAEs) during the study [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.

    2. Incidence of serious adverse event (SAE) during the study [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.

    Secondary Outcome Measures

    1. Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study [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.

    2. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008 [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))

    3. Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008 [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))

    4. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 As0009 30 Sarasota Florida United States 34239
    2 AS0009 1 Duncansville Pennsylvania United States 16635
    3 AS0009 6 Dallas Texas United States 75231
    4 As0009 156 Dobrich Bulgaria
    5 As0009 151 Plovdiv Bulgaria
    6 As0009 155 Plovdiv Bulgaria
    7 As0009 150 Ruse Bulgaria
    8 As0009 101 Quebec City Canada
    9 As0009 205 Brno Czechia
    10 As0009 207 Olomouc Czechia
    11 As0009 208 Pardubice Czechia
    12 As0009 210 Praha 11 Chodov Czechia
    13 As0009 211 Praha 3 Czechia
    14 As0009 201 Praha 4 Czechia
    15 As0009 202 Praha Czechia
    16 As0009 203 Zlin Czechia
    17 As0009 304 Hamburg Germany
    18 As0009 301 Ratingen Germany
    19 As0009 400 Budapest Hungary
    20 As0009 403 Budapest Hungary
    21 As0009 401 Veszprem Hungary
    22 As0009 466 Bydgoszcz Poland
    23 As0009 453 Elblag Poland
    24 As0009 456 Elblag Poland
    25 As0009 455 Krakow Poland
    26 As0009 461 Lublin Poland
    27 As0009 467 Nowa Sol Poland
    28 As0009 451 Poznan Poland
    29 As0009 450 Torun Poland
    30 As0009 454 Warszawa Poland
    31 As0009 459 Warszawa Poland
    32 As0009 457 Wroclaw Poland
    33 As0009 460 Wroclaw Poland
    34 As0009 465 Wroclaw Poland
    35 As0009 601 Moscow Russian Federation
    36 As0009 604 Moscow Russian Federation
    37 As0009 607 Moscow Russian Federation
    38 As0009 600 Saint Petersburg Russian Federation
    39 As0009 606 Saint Petersburg Russian Federation
    40 As0009 608 Saint Petersburg Russian Federation
    41 As0009 610 Saint-petersburg Russian Federation
    42 As0009 801 A Coruna Spain
    43 As0009 800 Cordoba Spain
    44 As0009 803 Santiago de Compostela Spain
    45 As0009 700 Kyiv Ukraine
    46 As0009 707 Kyiv Ukraine
    47 As0009 705 Ternopil Ukraine
    48 As0009 708 Uzhgorod Ukraine
    49 As0009 706 Vinnytsia Ukraine
    50 As0009 704 Zaporizhzhia Ukraine

    Sponsors and Collaborators

    • UCB Biopharma SRL

    Investigators

    • Study Director: UCB Cares, 001 844 599 2273

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UCB Biopharma SRL
    ClinicalTrials.gov Identifier:
    NCT03355573
    Other Study ID Numbers:
    • AS0009
    • 2017-001002-15
    First Posted:
    Nov 28, 2017
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by UCB Biopharma SRL
    Bimekizumab
    Ankylosing Spondylitis
    AS
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis
    Spondylitis, Ankylosing

    Study Results

    No Results Posted as of Aug 24, 2022