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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03215277
Registration number
NCT03215277
Ethics application status
Date submitted
5/07/2017
Date registered
12/07/2017
Date last updated
27/07/2023
Titles & IDs
Public title
A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis
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Scientific 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
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Secondary ID [1]
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2017-000957-37
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Secondary ID [2]
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AS0013
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Certolizumab pegol
Other interventions - Placebo
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.
Experimental: Certolizumab pegol - Subjects will receive several certolizumab pegol administrations on pre-defined time points.
Treatment: Drugs: Bimekizumab
One bimekizumab dose will be administered.
Treatment: Drugs: Certolizumab pegol
Two certolizumab pegol doses will be administered. One of these doses is a loading dose.
Other interventions: Placebo
Placebo will be provided to maintain the blinding.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
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Assessment method [1]
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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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Timepoint [1]
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From Baseline to Week 12
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Primary outcome [2]
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Number of Participants With Adverse Events (AE) During the Study Conduct
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Assessment method [2]
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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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Timepoint [2]
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From Baseline until Safety Follow-Up Visit (up to Week 64)
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Primary outcome [3]
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Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct
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Assessment method [3]
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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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Timepoint [3]
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From Baseline until Safety Follow-Up Visit (up to Week 64)
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Primary outcome [4]
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Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct
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Assessment method [4]
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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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Timepoint [4]
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From Baseline until Safety Follow-Up Visit (up to Week 64)
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Secondary outcome [1]
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Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12
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Assessment method [1]
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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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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12
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Assessment method [2]
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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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Timepoint [2]
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Baseline, Week 12
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Eligibility
Key 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:
1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >=4
2. 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 (TNFa) 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-TNFa agent. Subjects may not have been on more than 1
anti-TNFa 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject has received previous or current biological treatment other than TNFa
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 TNFa
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:
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
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/05/2020
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Sample size
Target
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Accrual to date
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Final
76
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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United States of America
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Nebraska
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United States of America
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Oklahoma
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United States of America
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Tennessee
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Country [5]
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Czechia
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State/province [5]
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Kladno
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Czechia
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State/province [6]
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Ostrava
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Czechia
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Praha 2
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Czechia
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Praha 3
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Hamburg
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Germany
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Herne
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Patra
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Greece
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Thessaloníki
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Moldova, Republic of
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Chisinau
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Netherlands
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Amsterdam
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Poland
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Bialystok
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Kraków
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Olsztyn
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Poznan
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Torun
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Poland
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Warsaw
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Country [30]
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Russian Federation
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State/province [30]
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Yaroslavl
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
UCB Biopharma SRL
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03215277
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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UCB Cares
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Address
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+1-844-599-2273 (UCB)
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03215277
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