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Ankylosing SpondylitisPhase 2BE AGILENCT02963506

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

A Phase 2 study testing Bimekizumab in people with Ankylosing Spondylitis, run by UCB Biopharma S.P.R.L. at 74 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Bimekizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
303 participants
Where
74 sitesin 10 countries
Study dates
Oct 2016to Aug 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • BASDAI score >=4
  • 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:
  • inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
Show all 16Show fewer
  • intolerance to administration of at least 1 NSAID
  • 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:
  • experienced an inadequate response to previous treatment given for at least 12 weeks
  • been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
  • lost access to TNF inhibitor for other reasons

Who cannot join

  • 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:
Show all 10Show fewer
  • <= 3 excised or ablated basal cell carcinomas of the skin
  • 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
  • Actinic keratosis (-es)
  • Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

Trial locations and contacts

74 sites in 10 countries.

74 sites in 10 countries

United States15 sites

  • As0008 019

    Anniston, Alabama, 36207

  • As0008 020

    Austin, Texas, 78731

  • As0008 005

    Aventura, Florida, 33180

  • As0008 027

    Boston, Massachusetts, 02111

  • As0008 015

    Cleveland, Ohio, 44109-19

  • As0008 006

    Dallas, Texas, 75231

  • As0008 001

    Duncansville, Pennsylvania, 16635

  • As0008 021

    Freehold, New Jersey, 07728

  • As0008 018

    Houston, Texas, 77030

  • As0008 007

    La Jolla, California, 92037

  • As0008 022

    Ormond Beach, Florida, 32174-11

  • As0008 014

    Portland, Oregon, 97239

  • As0008 030

    Sarasota, Florida, 34239

  • As0008 002

    Seattle, Washington, 98122

  • As0008 009

    Upland, California, 91786

Other trials in United States

Poland14 sites

  • As0008 466

    Bydgoszcz

  • As0008 453

    Elblag

  • As0008 456

    Elblag

  • As0008 455

    Krakow

  • As0008 461

    Lublin

  • As0008 467

    Nowa Sól

  • As0008 451

    Poznan

  • As0008 462

    Poznan

  • As0008 450

    Torun

  • As0008 454

    Warsaw

  • As0008 459

    Warsaw

  • As0008 457

    Wroclaw

  • As0008 460

    Wroclaw

  • As0008 465

    Wroclaw

Other trials in Poland

Czechia10 sites

  • As0008 205

    Brno

  • As0008 206

    Hustopeče

  • As0008 207

    Olomouc

  • As0008 208

    Pardubice

  • As0008 201

    Prague

  • As0008 202

    Prague

  • As0008 209

    Prague

  • As0008 210

    Prague

  • As0008 211

    Prague

  • As0008 203

    Zlín

Other trials in Czechia

Russia9 sites

  • As0008 601

    Moscow

  • As0008 604

    Moscow

  • As0008 605

    Moscow

  • As0008 607

    Moscow

  • As0008 600

    Saint Petersburg

  • As0008 606

    Saint Petersburg

  • As0008 608

    Saint Petersburg

  • As0008 609

    Saint Petersburg

  • As0008 610

    Saint Petersburg

Other trials in Russia

Ukraine6 sites

  • As0008 700

    Kiev

  • As0008 707

    Kyiv

  • As0008 705

    Ternopil

  • As0008 708

    Uzhhorod

  • As0008 706

    Vinnytsia

  • As0008 704

    Zaporizhya

Other trials in Ukraine

Bulgaria5 sites

  • As0008 156

    Dobrich

  • As0008 151

    Plovdiv

  • As0008 154

    Plovdiv

  • As0008 155

    Plovdiv

  • As0008 150

    Rousse

Other trials in Bulgaria

Germany5 sites

  • As0008 302

    Cologne

  • As0008 304

    Hamburg

  • As0008 308

    Hanover

  • As0008 303

    Herne

  • As0008 301

    Ratingen

Other trials in Germany

Hungary4 sites

  • As0008 400

    Budapest

  • As0008 403

    Budapest

  • As0008 402

    Debrecen

  • As0008 401

    Veszprém

Other trials in Hungary

Canada3 sites

  • As0008 101

    Québec

  • As0008 100

    Victoria

  • As0008 103

    Winnipeg

Other trials in Canada

Spain3 sites

  • As0008 801

    A Coruña

  • As0008 800

    Córdoba

  • As0008 803

    Santiago de Compostela

Other trials in Spain

About this study

Official title: 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).

Being tested
Placebo, Bimekizumab
Keywords
AS, Ankylosing Spondylitis, Bimekizumab
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

  • BimekizumabDrug

    Also called UCB4940

    Bimekizumab in different dosages.

Study groups in NCT02963506
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
Receives: Other: Placebo
Bimekizumab Dose 1ExperimentalSubjects 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.
Receives: Drug: Bimekizumab
Bimekizumab Dose 2ExperimentalSubjects 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.
Receives: Drug: Bimekizumab
Bimekizumab Dose 3ExperimentalSubjects will receive for 48 Weeks Bimekizumab Dose 3.
Receives: Drug: Bimekizumab
Bimekizumab Dose 4ExperimentalSubjects will receive for 48 Weeks Bimekizumab Dose 4.
Receives: Drug: Bimekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at 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.

    Measured: Week 12

Secondary outcomes (8)

  1. Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at 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.

    Measured: From Baseline to Week 12

  2. Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at 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.

    Measured: Week 12

  3. Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at 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.

    Measured: Week 12

  4. Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    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.

    Measured: From Baseline to Week 12

  5. Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)

    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.

    Measured: From Baseline to Week 12

  6. Percentage of Participants With at Least One Adverse Event (AE) During the Study

    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.

    Measured: From Screening until Safety Follow-Up Visit (up to Week 77)

  7. Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study

    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.

    Measured: From Screening until Safety Follow-Up Visit (up to Week 77)

  8. Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study

    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.

    Measured: From Screening until Safety Follow-Up Visit (up to Week 77)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2017
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02963506
Sponsor's protocol ID
AS0008
Other IDs
2016-001102-42, 2016
Acronym
BE AGILE
Status last verified
May 2023
First submitted
10 Nov 2016
Last updated
6 Jun 2023
Data monitoring committee
Yes

Publications

  • van der Heijde D, Gensler LS, Deodhar A, Baraliakos X, Poddubnyy D, Kivitz A, Farmer MK, Baeten D, Goldammer N, Coarse J, Oortgiesen M, Dougados M. Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2020 May;79(5):595-604. doi: 10.1136/annrheumdis-2020-216980. Epub 2020 Apr 6.

    PubMed 32253184

  • 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.

    PubMed 35833532

  • Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.

    PubMed 41807031

  • Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.

    PubMed 40194794

  • Deodhar A, Navarro-Compan V, Poddubnyy D, Gensler LS, Ramiro S, Tomita T, Marzo-Ortega H, Fleurinck C, Vaux T, Massow U, de Peyrecave N, van der Heijde D, Baraliakos X. Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension. RMD Open. 2025 Jan 31;11(1):e005081. doi: 10.1136/rmdopen-2024-005081.

    PubMed 39890205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bimekizumab in people with Ankylosing Spondylitis, run by UCB Biopharma S.P.R.L. at 74 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Poland, Czechia, Russia, Ukraine and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02963506, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.

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