18 and older, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the StudyPrimary· From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant 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. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 an
Group
Value
95% CI
Bimekizumab
92.9
Percentage of Participants With Serious Adverse Event (SAE) During the StudyPrimary· From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Is a congenital anomaly or birth defect 5) Is an infection that requires treatment with parenteral antibiotics 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.
Group
Value
95% CI
Bimekizumab
18.0
Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the StudySecondary· From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant 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. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 an
Group
Value
95% CI
Bimekizumab
6.7
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008Secondary· Baseline of AS0008, Week 48 (AS0009)
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA) (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of Bath Ankylo
Non-responder imputation
Group
Value
95% CI
Bimekizumab
67.1
Observed case
Group
Value
95% CI
Bimekizumab
70.5
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008Secondary· Baseline of AS0008, Week 48 (AS0009)
The ASAS20 response was defined as relative improvements of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (BASFI) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and n
Non-responder imputation
Group
Value
95% CI
Bimekizumab
79.9
Observed case
Group
Value
95% CI
Bimekizumab
84.0
Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48Secondary· Baseline of AS0008, Week 48 (AS0009)
BASDAI is a validated self-reported instrument, which consisted of 6 questions to measure the disease activity of ankylosing spondylitis (AS) from the participant's perspective. It measured the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration). Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided
Group
Value
95% CI
Bimekizumab
-3.79
± 0.13
Adverse events — posted to ClinicalTrials.gov
Time frame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Other recruiting trials for Ankylosing Spondylitis
Currently open trials in the same condition.
NCT07510789 — Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis
· recruiting
NCT07261644 — A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
· Phase 3
· recruiting
NCT07390929 — Clinical Trial Study on the Improved New Method of Acupotomy for AS
· NA
· recruiting
NCT06905288 — Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
· recruiting
NCT07166874 — The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis
· NA
· recruiting
Other UCB Biopharma SRL trials
Trials by the same sponsor.
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NCT07286682 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma SRL
Last refreshed: 21 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03355573.