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

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ClinicalTrials.gov Identifier: NCT02963506
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Name: UCB4940

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.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Name: UCB4940

Experimental: Bimekizumab Dose 3
Subjects will receive for 48 Weeks Bimekizumab Dose 3.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Name: UCB4940

Experimental: Bimekizumab Dose 4
Subjects will receive for 48 Weeks Bimekizumab Dose 4.
Drug: Bimekizumab
Bimekizumab in different dosages.
Other Name: UCB4940




Primary Outcome Measures :
  1. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 [ Time Frame: Baseline, Week 12 ]
  2. Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 12 [ Time Frame: Week 12 ]
  3. Subjects with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12 [ Time Frame: Week 12 ]
  4. Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Week 12 ]
  5. Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Week 12 ]
  6. Percentage of subjects with at least one Adverse Event (AE) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up Visit ]
  7. 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 ]
  8. 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 ]


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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:

  • 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

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): NCT02963506


  Show 74 Study Locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02963506     History of Changes
Other Study ID Numbers: AS0008
2016-001102-42 ( EudraCT Number )
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis