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Trial record 33 of 298 for:    "Ankylosing spondylitis"

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

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ClinicalTrials.gov Identifier: NCT03215277
Recruitment Status : Active, not recruiting
First Posted : July 12, 2017
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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)

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Bimekizumab Drug: Certolizumab Pegol Other: Placebo Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
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 Name: UCB4940

Other: 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




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215277


  Show 34 Study Locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares +1-844-599-2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03215277     History of Changes
Other Study ID Numbers: AS0013
2017-000957-37 ( EudraCT Number )
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Ankylosing Spondylitis
Bimekizumab
AS
Certolizumab Pegol
Cimzia

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents