A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis (BE AGILE)

May 9, 2023 updated by: UCB Biopharma S.P.R.L.

A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

303

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
        • As0008 156
      • Plovdiv, Bulgaria
        • As0008 151
      • Plovdiv, Bulgaria
        • As0008 154
      • Plovdiv, Bulgaria
        • As0008 155
      • Ruse, Bulgaria
        • As0008 150
  • Canada
      • Quebec, Canada
        • As0008 101
      • Victoria, Canada
        • As0008 100
      • Winnipeg, Canada
        • As0008 103
  • Czechia
      • Brno, Czechia
        • As0008 205
      • Hustopece, Czechia
        • As0008 206
      • Olomouc, Czechia
        • As0008 207
      • Pardubice, Czechia
        • As0008 208
      • Praha, Czechia
        • As0008 211
      • Praha 11, Czechia
        • As0008 210
      • Praha 2, Czechia
        • As0008 202
      • Praha 4, Czechia
        • As0008 201
      • Praha 4, Czechia
        • As0008 209
      • Zlín, Czechia
        • As0008 203
  • Germany
      • Cologne, Germany
        • As0008 302
      • Hamburg, Germany
        • As0008 304
      • Hannover, Germany
        • As0008 308
      • Herne, Germany
        • As0008 303
      • Ratingen, Germany
        • As0008 301
  • Hungary
      • Budapest, Hungary
        • As0008 400
      • Budapest, Hungary
        • As0008 403
      • Debrecen, Hungary
        • As0008 402
      • Veszprem, Hungary
        • As0008 401
  • Poland
      • Bydgoszcz, Poland
        • As0008 466
      • Elblag, Poland
        • As0008 453
      • Elblag, Poland
        • As0008 456
      • Krakow, Poland
        • As0008 455
      • Lublin, Poland
        • As0008 461
      • Nowa Sol, Poland
        • As0008 467
      • Poznan, Poland
        • As0008 451
      • Poznan, Poland
        • As0008 462
      • Torun, Poland
        • As0008 450
      • Warszawa, Poland
        • As0008 454
      • Warszawa, Poland
        • As0008 459
      • Wroclaw, Poland
        • As0008 457
      • Wroclaw, Poland
        • As0008 460
      • Wroclaw, Poland
        • As0008 465
  • Russian Federation
      • Moscow, Russian Federation
        • As0008 601
      • Moscow, Russian Federation
        • As0008 604
      • Moscow, Russian Federation
        • As0008 605
      • Moscow, Russian Federation
        • As0008 607
      • Saint Petersburg, Russian Federation
        • As0008 600
      • Saint Petersburg, Russian Federation
        • As0008 606
      • Saint Petersburg, Russian Federation
        • As0008 608
      • Saint Petersburg, Russian Federation
        • As0008 609
      • Saint Petersburg, Russian Federation
        • As0008 610
  • Spain
      • Cordoba, Spain
        • As0008 800
      • La Coruna, Spain
        • As0008 801
      • Santiago de Compostela, Spain
        • As0008 803
  • Ukraine
      • Kiev, Ukraine
        • As0008 700
      • Kyiv, Ukraine
        • As0008 707
      • Ternopil, Ukraine
        • As0008 705
      • Uzhgorod, Ukraine
        • As0008 708
      • Vinnytsya, Ukraine
        • As0008 706
      • Zaporizhya, Ukraine
        • As0008 704
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • As0008 019
    • California
      • La Jolla, California, United States, 92037
        • As0008 007
      • Upland, California, United States, 91786
        • As0008 009
    • Florida
      • Aventura, Florida, United States, 33180
        • As0008 005
      • Ormond Beach, Florida, United States, 32174-11
        • As0008 022
      • Sarasota, Florida, United States, 34239
        • As0008 030
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • As0008 027
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • As0008 021
    • Ohio
      • Cleveland, Ohio, United States, 44109-19
        • As0008 015
    • Oregon
      • Portland, Oregon, United States, 97239
        • As0008 014
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • As0008 001
    • Texas
      • Austin, Texas, United States, 78731
        • As0008 020
      • Dallas, Texas, United States, 75231
        • As0008 006
      • Houston, Texas, United States, 77030
        • As0008 018
    • Washington
      • Seattle, Washington, United States, 98122
        • As0008 002

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has active ankylosing spondylitis (AS), determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for >=3 months and age of onset <45 years

  • Subject has moderate to severe active disease as defined by each of the following:

    1. BASDAI score >=4
    2. Spinal pain >=4 on a 0 to 10 NRS (Numeric Rating Scale; from BASDAI item 2)

  • Subjects must have at least 1 of the following:

    1. inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
    2. intolerance to administration of at least 1 NSAID
    3. contraindication(s) to NSAID therapy
  • Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
  • Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
  • Subjects taking methotrexate (MTX) (<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
  • Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization

  • Subjects may be tumor necrosis factor (TNF) inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:

    1. experienced an inadequate response to previous treatment given for at least 12 weeks
    2. been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
    3. lost access to TNF inhibitor for other reasons

Exclusion Criteria:

  • Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg, rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
  • Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
  • Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
  • Subjects receiving any live vaccination within the 8 weeks prior to Baseline
  • Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection

  • Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:

    1. <= 3 excised or ablated basal cell carcinomas of the skin
    2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
    3. Actinic keratosis (-es)
    4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Other: Placebo
Experimental: Bimekizumab Dose 1
Subjects will receive for 12 Weeks Bimekizumab Dose 1 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Names:
  • UCB4940
Experimental: Bimekizumab Dose 2
Subjects will receive for 12 Weeks Bimekizumab Dose 2 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Names:
  • UCB4940
Experimental: Bimekizumab Dose 3
Subjects will receive for 48 Weeks Bimekizumab Dose 3.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Names:
  • UCB4940
Experimental: Bimekizumab Dose 4
Subjects will receive for 48 Weeks Bimekizumab Dose 4.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Names:
  • UCB4940

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12
Time Frame: Week 12

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), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.

Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
Time Frame: From Baseline to Week 12

The ASDAS was calculated as the sum of the following components:

0.121 x Back pain (BASDAI question 2 result) 0.058 x Duration of morning stiffness (BASDAI question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI question 3 result) 0.579 x (natural logarithm of the (hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).

The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score since CRP does not have a set upper limit.

If one component for the ASDAS-CRP was missing at a given visit, that component was imputed by carrying the last observation forward, and the ASDAS-CRP was calculated accordingly. If the hs-CRP value was below 2 mg/L, then it was imputed as the constant value of 2 mg/L.
From Baseline to Week 12
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12
Time Frame: Week 12

The ASAS20 response was defined as an improvement 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, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit].

Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Week 12
Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12
Time Frame: Week 12

The ASAS 5/6 response was defined as at least 20% improvement in at least 5 of the 6 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP).

Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.
Week 12
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: From Baseline to Week 12

The BASDAI is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.

The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
From Baseline to Week 12
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: From Baseline to Week 12

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function.

The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random.
From Baseline to Week 12
Percentage of Participants With at Least One Adverse Event (AE) During the Study
Time Frame: From Screening until Safety Follow-Up Visit (up to Week 77)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can 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 Screening until Safety Follow-Up Visit (up to Week 77)
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
Time Frame: From Screening until Safety Follow-Up Visit (up to Week 77)

A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalisation or prolongation of existing hospitalisation
  • Is a congenital anomaly or birth defect
  • Is an infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.
From Screening until Safety Follow-Up Visit (up to Week 77)
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
Time Frame: From Screening until Safety Follow-Up Visit (up to Week 77)

An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device.

The event does not necessarily have a causal relationship with that treatment or usage. The results of this Secondary Outcome Measure were summarized from the adverse event pages of the Case Report Forms.
From Screening until Safety Follow-Up Visit (up to Week 77)

Collaborators and Investigators

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

Sponsor

UCB Biopharma S.P.R.L.

Investigators

  • Study Director: UCB Cares, +1 844 599 2273(UCB)

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)

October 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimated)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS0008
  • 2016-001102-42 (EudraCT Number)

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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