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Phase 2 N=303 Randomized Quadruple-blind Treatment

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

Ankylosing Spondylitis

Enrolled (actual)
303
Serious AEs
3.1%
Results posted
Nov 2020
Primary outcome: Primary: Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12 — 13.3; 29.5; 42.6; 46.7 percentage of participants — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Placebo (Other); Bimekizumab (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
UCB Biopharma S.P.R.L.
Primary completion
Oct 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12
13.3; 29.5; 42.6; 46.7; 45.9 <0.001 sig
SECONDARY
Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
-0.3; -0.8; -1.4; -1.3; -1.4 <0.001 sig
SECONDARY
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12
28.3; 41.0; 62.3; 58.3; 72.1 =0.163
SECONDARY
Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12
6.7; 29.5; 49.2; 53.3; 54.1 =0.003 sig
SECONDARY
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
-1.0; -1.6; -2.6; -2.6; -2.9 =0.094
SECONDARY
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
-0.7; -1.4; -1.8; -1.9; -2.2 =0.075
SECONDARY
Percentage of Participants With at Least One Adverse Event (AE) During the Study
45.0; 44.3; 34.5; 69.8; 82.0
SECONDARY
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
3.3; 0; 3.4; 3.4; 4.0
SECONDARY
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
1.7; 3.3; 1.7; 4.7; 6.7

Summary

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

Eligibility 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 =4
  • 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:
  • inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
  • intolerance to administration of at least 1 NSAID
  • 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:
  • experienced an inadequate response to previous treatment given for at least 12 weeks
  • been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
  • 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:
  • <= 3 excised or ablated basal cell carcinomas of the skin
  • 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
  • Actinic keratosis (-es)
  • Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02963506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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