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Ankylosing SpondylitisPhase 2NCT03215277

A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

A Phase 2 study testing Bimekizumab and Certolizumab pegol in people with Ankylosing Spondylitis, run by UCB Biopharma SRL at 34 sites in 8 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

The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared to certolizumab pegol in the treatment of 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 and Certolizumab pegol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
34 sitesin 8 countries
Study dates
4 Oct 2017to 25 May 2020
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

  • Documented diagnosis of active adult-onset ankylosing spondylitis (AS) as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset <45 years
  • Subject has moderate to severe active disease at the Screening Visit as defined by each of the following:
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >=4
  • Spinal pain >=4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)
  • Subjects must have had an inadequate response to, have a contraindication to, or have been intolerant to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Subjects taking corticosteroids must be on a maximum daily dose of <=10mg/day oral prednisolone or equivalent
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  • Subjects taking methotrexate (MTX; <=25 mg/week) are allowed to continue their medication if they received a stable dose for at least 12 weeks before randomization
  • Subjects taking sulfasalazine (up to 3 grams/day) or hydroxychloroquine (up to 400 mg per day total) are allowed to continue their medication if started at least 12 weeks prior to randomization
  • Subject who has been on an anti-tumor necrosis factor alpha (TNFα) agent must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months or have been intolerant to at least 1 administration of an anti-TNFα agent. Subjects may not have been on more than 1 anti-TNFα agent
  • Subject has high-sensitive C-Reactive Protein (hsCRP) levels >=3 mg/L at the Screening Visit
  • Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of investigational medicinal product (IMP)
  • Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of IMP

Who cannot join

  • Subject has received previous or current biological treatment other than TNFα inhibitor treatment
  • 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)
  • Subject has received previous or current biological treatment other than TNFα inhibitor treatment
  • Subject has chronic, recurrent, recent serious / life-threatening or current infection, as defined in the protocol
  • Subject has history of certain atypical infections, viral hepatitides, human immunodeficiency virus (HIV) infection, tuberculosis, as defined in the protocol
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  • 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
  • Subject has immunosuppressive condition or treatment, recent history of malignancy (some exceptions) or demyelinating disease
  • Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
  • <= 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
  • Subject has history of psychiatric disorder, including suicidality (as defined in the protocol
  • Subject has major abnormalities on laboratory testing, as defined in the protocol

Trial locations and contacts

34 sites in 8 countries.

34 sites in 8 countries

Poland8 sites

  • As0013 708

    Bialystok

  • As0013 709

    Krakow

  • As0013 706

    Olsztyn

  • As0013 703

    Poznan

  • As0013 702

    Torun

  • As0013 701

    Warsaw

  • As0013 704

    Warsaw

  • As0013 707

    Wroclaw

Other trials in Poland

Russia6 sites

  • As0013 801

    Kazan'

  • As0013 803

    Kemerovo

  • As0013 806

    Moscow

  • As0013 807

    Moscow

  • As0013 802

    Yaroslavl

  • As0013 805

    Yaroslavl

Other trials in Russia

Germany5 sites

  • As0013 302

    Berlin

  • As0013 306

    Berlin

  • As0013 304

    Erlangen

  • As0013 303

    Hamburg

  • As0013 301

    Herne

Other trials in Germany

Greece5 sites

  • As0013 405

    Athens

  • As0013 404

    Heraklion

  • As0013 401

    Pátrai

  • As0013 402

    Thessaloniki

  • As0013 406

    Thessaloniki

Other trials in Greece

United States4 sites

  • As0013 903

    Lincoln, Nebraska, 68516

  • As0013 906

    Memphis, Tennessee, 38119

  • As0013 902

    Oklahoma City, Oklahoma, 73103

  • As0013 908

    Ormond Beach, Florida, 32174

Other trials in United States

Czechia4 sites

  • As0013 202

    Kladno

  • As0013 205

    Ostrava

  • As0013 201

    Prague

  • As0013 203

    Prague

Other trials in Czechia

Moldova1 site

  • As0013 501

    Chisinau

Other trials in Moldova

Netherlands1 site

  • As0013 601

    Amsterdam

Other trials in Netherlands

About this study

Official title: A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing Spondylitis

The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared to certolizumab pegol in the treatment of subjects with active ankylosing spondylitis (AS).

Being tested
Bimekizumab, Certolizumab pegol, Placebo
Keywords
Ankylosing Spondylitis, Bimekizumab, AS, Certolizumab Pegol, Cimzia
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • BimekizumabDrug

    Also called UCB4940, BKZ

    One bimekizumab dose will be administered.

  • Certolizumab pegolDrug

    Also called CZP, Cimzia, CDP870

    Two certolizumab pegol doses will be administered. One of these doses is a loading dose.

  • PlaceboOther

    Placebo will be provided to maintain the blinding.

Study groups in NCT03215277
Study groupRoleWhat they receive
BimekizumabExperimentalSubjects will receive several bimekizumab administrations on pre-defined time points. Placebo will be provided in this arm to mask the certolizumab pegol loading dose.
Receives: Drug: Bimekizumab; Other: Placebo
Certolizumab pegolExperimentalSubjects will receive several certolizumab pegol administrations on pre-defined time points.
Receives: Drug: Certolizumab pegol

What is being measured

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

  1. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

    ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Posterior means and 95% credible intervals in each group are presented.

    Measured: From Baseline to Week 12

  2. Number of Participants With Adverse Events (AE) During the Study Conduct

    An AE was any untoward medical occurrence in a patient or clinical investigation participant 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. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

    Measured: From Baseline until Safety Follow-Up Visit (up to Week 64)

  3. Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct

    An SAE was any untoward medical occurrence that at any dose: - Resulted in death - Is life-threatening - Required in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment with parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardised the participants, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

    Measured: From Baseline until Safety Follow-Up Visit (up to Week 64)

  4. Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct

    An AE was any untoward medical occurrence in a patient or clinical investigation participant 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. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.

    Measured: From Baseline until Safety Follow-Up Visit (up to Week 64)

Secondary outcomes (2)

  1. Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12

    ASDAS-ID was defined by ASDAS < 1.3. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score.

    Measured: Week 12

  2. Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12

    ASDAS-MI was defined by a reduction (improvement) from Baseline in ASDAS >=2 units. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score.

    Measured: Baseline, Week 12

Timeline

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

  1. First posted12 Jul 2017
  2. Study start4 Oct 2017
  3. Primary completion25 May 2020
  4. Study completion25 May 2020

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
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03215277
Sponsor's protocol ID
AS0013
Other IDs
2017-000957-37, 2017
Status last verified
Jul 2023
First submitted
5 Jul 2017
Last updated
27 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
Expanded access
Available

Publications

  • Baraliakos X, de Jongh J, Poddubnyy D, Zwezerijnen GJC, Hemke R, Glatt S, Shaw S, Ionescu L, El Baghdady A, Mann J, Maguire RP, Vaux T, de Peyrecave N, Oortgiesen M, Baeten D, van der Laken C. Impact of bimekizumab and certolizumab pegol on efficacy, safety and osteoblastic activity in radiographic axial spondyloarthritis: results from a phase IIa, multicentre, randomised, double-blind, exploratory study with PET-CT imaging. Ther Adv Musculoskelet Dis. 2024 Nov 28;16:1759720X241293944. doi: 10.1177/1759720X241293944. eCollection 2024.

    PubMed 39620046

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bimekizumab and Certolizumab pegol in people with Ankylosing Spondylitis, run by UCB Biopharma SRL at 34 sites in 8 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 12 inclusion and 16 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Poland, Russia, Germany, Greece, United States and 3 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. 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 27 Jul 2023). 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?

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 (time frame: From Baseline to Week 12). The study lists 4 primary outcomes in all. 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 NCT03215277, which also lists 1 linked publication.

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 27 Jul 2023.

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