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A Multicenter Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963506
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 12 [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 12 [ Time Frame: Week 12 ]
  • Subjects with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12 [ Time Frame: Week 12 ]
  • Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Week 12 ]
  • Percentage of subjects with at least one Adverse Event (AE) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up Visit ]
  • Percentage of subjects with at least one Serious Adverse Event (SAE) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up Visit ]
  • Percentage of subjects who withdrew due to an Adverse Event (AE) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up Visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 12 [ Time Frame: Week 12 ]
  • Subjects with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12 [ Time Frame: Week 12 ]
  • Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Official Title  ICMJE A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Brief Summary This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Other: Placebo
  • Drug: Bimekizumab
    Bimekizumab in different dosages.
    Other Name: UCB4940
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
    Intervention: Other: Placebo
  • Experimental: Bimekizumab Dose 1
    Subjects will receive for 12 Weeks Bimekizumab Dose 1 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
    Intervention: Drug: Bimekizumab
  • Experimental: Bimekizumab Dose 2
    Subjects will receive for 12 Weeks Bimekizumab Dose 2 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
    Intervention: Drug: Bimekizumab
  • Experimental: Bimekizumab Dose 3
    Subjects will receive for 48 Weeks Bimekizumab Dose 3.
    Intervention: Drug: Bimekizumab
  • Experimental: Bimekizumab Dose 4
    Subjects will receive for 48 Weeks Bimekizumab Dose 4.
    Intervention: Drug: Bimekizumab
Publications * van der Heijde D, Gensler LS, Deodhar A, Baraliakos X, Poddubnyy D, Kivitz A, Farmer MK, Baeten D, Goldammer N, Coarse J, Oortgiesen M, Dougados M. Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2020 May;79(5):595-604. doi: 10.1136/annrheumdis-2020-216980. Epub 2020 Apr 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
303
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2016)
285
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has active ankylosing spondylitis (AS), determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for >=3 months and age of onset <45 years
  • Subject has moderate to severe active disease as defined by each of the following:

    1. BASDAI score >=4
    2. Spinal pain >=4 on a 0 to 10 NRS (Numeric Rating Scale; from BASDAI item 2)
  • Subjects must have at least 1 of the following:

    1. inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
    2. intolerance to administration of at least 1 NSAID
    3. contraindication(s) to NSAID therapy
  • Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
  • Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
  • Subjects taking methotrexate (MTX) (<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 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 Baseline, with a stable dose for at least 8 weeks before randomization
  • Subjects may be tumor necrosis factor (TNF) inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:

    1. experienced an inadequate response to previous treatment given for at least 12 weeks
    2. been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
    3. lost access to TNF inhibitor for other reasons

Exclusion Criteria:

  • 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)
  • Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   Germany,   Hungary,   Poland,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02963506
Other Study ID Numbers  ICMJE AS0008
2016-001102-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273(UCB)
PRS Account UCB Pharma
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP