- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03215277
A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis
July 7, 2023 updated by: UCB Biopharma SRL
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 2
Expanded Access
Available outside the clinical trial.
See expanded access record.
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
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Kladno, Czechia
- As0013 202
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Ostrava, Czechia
- As0013 205
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Praha 2, Czechia
- As0013 201
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Praha 3, Czechia
- As0013 203
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Berlin, Germany
- As0013 302
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Berlin, Germany
- As0013 306
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Erlangen, Germany
- As0013 304
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Hamburg, Germany
- As0013 303
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Herne, Germany
- As0013 301
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Athens, Greece
- As0013 405
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Heraklion, Greece
- As0013 404
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Patra, Greece
- As0013 401
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Thessaloníki, Greece
- As0013 402
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Thessaloníki, Greece
- As0013 406
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Chisinau, Moldova, Republic of
- As0013 501
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Amsterdam, Netherlands
- As0013 601
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Białystok, Poland
- As0013 708
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Kraków, Poland
- As0013 709
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Olsztyn, Poland
- As0013 706
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Poznań, Poland
- As0013 703
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Toruń, Poland
- As0013 702
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Warsaw, Poland
- As0013 701
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Warszawa, Poland
- As0013 704
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Wrocław, Poland
- As0013 707
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Kazan, Russian Federation
- As0013 801
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Kemerovo, Russian Federation
- As0013 803
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Moscow, Russian Federation
- As0013 806
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Moscow, Russian Federation
- As0013 807
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Yaroslavl, Russian Federation
- As0013 802
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Yaroslavl, Russian Federation
- As0013 805
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Florida
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Ormond Beach, Florida, United States, 32174
- As0013 908
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Nebraska
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Lincoln, Nebraska, United States, 68516
- As0013 903
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- As0013 902
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Tennessee
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Memphis, Tennessee, United States, 38119
- As0013 906
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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:
- 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
- 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
Exclusion Criteria:
- 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
- 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
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 |
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Experimental: Bimekizumab
Subjects will receive several bimekizumab administrations on pre-defined time points.
Placebo will be provided in this arm to mask the certolizumab pegol loading dose.
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One bimekizumab dose will be administered.
Other Names:
Placebo will be provided to maintain the blinding.
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Experimental: Certolizumab pegol
Subjects will receive several certolizumab pegol administrations on pre-defined time points.
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Two certolizumab pegol doses will be administered.
One of these doses is a loading dose.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
Time Frame: From Baseline to Week 12
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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.
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From Baseline to Week 12
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Number of Participants With Adverse Events (AE) During the Study Conduct
Time Frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
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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.
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From Baseline until Safety Follow-Up Visit (up to Week 64)
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Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct
Time Frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
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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.
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From Baseline until Safety Follow-Up Visit (up to Week 64)
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Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct
Time Frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
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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.
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From Baseline until Safety Follow-Up Visit (up to Week 64)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12
Time Frame: Week 12
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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.
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Week 12
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Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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 4, 2017
Primary Completion (Actual)
May 25, 2020
Study Completion (Actual)
May 25, 2020
Study Registration Dates
First Submitted
July 5, 2017
First Submitted That Met QC Criteria
July 11, 2017
First Posted (Actual)
July 12, 2017
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Axial Spondyloarthritis
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tumor Necrosis Factor Inhibitors
- Certolizumab Pegol
Other Study ID Numbers
- AS0013
- 2017-000957-37 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
Qualified researchers 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
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.
No
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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