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History of Changes for Study: NCT03215277
Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis.
Latest version (submitted May 21, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 11, 2017 None (earliest Version on record)
2 September 27, 2017 Study Status
3 October 25, 2017 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 November 23, 2017 Study Status and Contacts/Locations
5 December 18, 2017 Study Status and Contacts/Locations
6 January 17, 2018 Study Status and Contacts/Locations
7 February 13, 2018 Contacts/Locations and Study Status
8 April 4, 2018 Study Status
9 April 11, 2018 Contacts/Locations and Study Status
10 April 26, 2018 Contacts/Locations and Study Status
11 May 10, 2018 Contacts/Locations and Study Status
12 May 24, 2018 Contacts/Locations and Study Status
13 June 7, 2018 Contacts/Locations and Study Status
14 June 21, 2018 Contacts/Locations and Study Status
15 July 4, 2018 Study Status
16 July 6, 2018 Contacts/Locations and Study Status
17 July 19, 2018 Contacts/Locations and Study Status
18 August 16, 2018 Contacts/Locations and Study Status
19 August 29, 2018 Contacts/Locations and Study Status
20 October 17, 2018 Study Status
21 October 25, 2018 Study Status
22 November 8, 2018 Study Status
23 December 5, 2018 Study Status
24 December 13, 2018 Study Status and Contacts/Locations
25 February 13, 2019 Study Status and Contacts/Locations
26 March 6, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
27 March 21, 2019 Contacts/Locations and Study Status
28 March 28, 2019 Study Status
29 July 22, 2019 Study Status
30 September 16, 2019 Study Status
31 October 14, 2019 Arms and Interventions, IPDSharing, Outcome Measures, Study Design, Study Status, Contacts/Locations, Eligibility, Study Description and Study Identification
32 January 3, 2020 Study Status
33 January 20, 2020 Study Status
34 January 30, 2020 Study Status
35 April 8, 2020 Study Status
36 June 24, 2020 Recruitment Status and Study Status
37 July 2, 2020 Study Status and Contacts/Locations
38 May 21, 2021 Study Status and Study Design
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Study NCT03215277
Submitted Date:  July 11, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: AS0013
Brief Title: Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis.
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
Secondary IDs: 2017-000957-37 [EudraCT Number]
Open or close this module Study Status
Record Verification: July 2017
Overall Status: Not yet recruiting
Study Start: July 27, 2017
Primary Completion: February 16, 2018 [Anticipated]
Study Completion: March 1, 2019 [Anticipated]
First Submitted: July 5, 2017
First Submitted that
Met QC Criteria:
July 11, 2017
First Posted: July 12, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
July 11, 2017
Last Update Posted: July 12, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: UCB Biopharma S.P.R.L.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Study to evaluate the efficacy and safety of Bimekizumab compared to Certolizumab Pegol in the treatment of subjects with active ankylosing spondylitis (AS)
Detailed Description:
Open or close this module Conditions
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Bimekizumab
AS
Certolizumab Pegol
Cimzia
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Bimekizumab Arm
Subjects will receive several Bimekizumab applications on pre-defined time points. Placebo will be provided in this arm to mask the Certolizumab Pegol loading dose.
Drug: Bimekizumab
One Bimekizumab dose will be applied.
Other Names:
  • UCB4940
Placebo
Placebo will be provided to keep the blinding.
Experimental: Certolizumab Pegol Arm
Subjects will receive several Certolizumab Pegol applications on pre-defined time points.
Drug: Certolizumab Pegol
Two Certolizumab Pegol dosages will be applied.
Other Names:
  • CZP
  • Cimzia
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
[ Time Frame: From Baseline to Week 12 ]

The ASDAS score is calculated as the sum of the following components:

0.121 × Back pain (BASDAI Question (Q)2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × PtGADA, 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm of the CRP [mg/L] + 1) Spinal pain, PtGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The results of these calculations are summed to calculate the ASDAS.

2. Incidence of Adverse Events (AE) during the study conduct
[ Time Frame: From Screening until Safety Follow-Up Visit (up to Week 64) ]

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
3. Incidence of Serious Adverse Events (SAEs) during the study conduct
[ Time Frame: From Screening until Safety Follow-Up Visit (up to Week 64) ]

An 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 as infection that requires treatment with 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
4. Number of subjects who withdrew due to an Adverse Event (AE) during the study conduct
[ Time Frame: From Screening until Safety Follow-Up Visit (up to Week 64) ]

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Secondary Outcome Measures:
1. Percentage of subjects meeting the Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS-ID) response criteria at Week 12
[ Time Frame: Week 12 ]

The ASDAS-Inactive Disease score is defined as: ASDAS < 1.3.

The ASDAS score is calculated as the sum of the following components:

0.121 × Back pain (BASDAI Question (Q)2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × PtGADA, 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm of the CRP [mg/L] + 1) Spinal pain, PtGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The results of these calculations are summed to calculate the ASDAS.

2. Percentage of subjects meeting the Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response criteria at Week 12
[ Time Frame: Week 12 ]

ASDAS-MI is achieved when there is a reduction (improvement) >= 2.0 in the ASDAS relative to Baseline. The ASDAS is calculated as the sum of the following components:

0.121 × Back pain (BASDAI Q2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × PtGADA 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm of the CRP [mg/L] + 1) Back pain, PtGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The results of these calculations are summed to calculate the ASDAS.

3. Osteoblastic activity as detected by imaging techniques at Week 12
[ Time Frame: Week 12 ]

The 18F-fluoride positron-emission tomography - magnetic resonance imaging (PET-MRIs) of the whole spine will be performed by using a whole-body PET/MRI system. Alternatively, subjects will be examined in supine position on a combined PET-computerized tomography (CT) system permitting the acquisition of co-registered CT and PET images in the same session. The PET-MRI or PET-CT scan will be performed at time points provided in approximately 25 subjects at selected sites.
4. Osteoblastic activity as detected by imaging techniques at Week 48
[ Time Frame: Week 48 ]

The 18F-fluoride positron-emission tomography - magnetic resonance imaging (PET-MRIs) of the whole spine will be performed by using a whole-body PET/MRI system. Alternatively, subjects will be examined in supine position on a combined PET-computerized tomography (CT) system permitting the acquisition of co-registered CT and PET images in the same session. The PET-MRI or PET-CT scan will be performed at time points provided in approximately 25 subjects at selected sites.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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. 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; <=25mg/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 3grams/day) or hydroxychloroquine (up to 400mg 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-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-tumor necrosis factor alpha (TNFα) agent. Subjects may not have been on more than 1 anti-TNFα agent.
  • Subject has high-sensitive C-Reactive Protein (hsCRP) levels >=3mg/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, 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
Open or close this module Contacts/Locations
Central Contact Person: UCB Cares
Telephone: +1844599 Ext. 2273
Email: UCBCares@ucb.com
Study Officials: UCB Cares
Study Director
+1-844-599-2273 (UCB)
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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