A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
- Registration Number
- NCT03355573
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- Subject completed AS0008 without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
- Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bimekizumab Bimekizumab Subjects will receive bimekizumab up to 4 years.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study 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 and on or before 140 days after the final study medication administration.
Percentage of Participants With Serious Adverse Event (SAE) During the Study 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study 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 and on or before 140 days after the final study medication administration.
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008 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 Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008 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 no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.
Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48 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 by 5. The total BASDAI score was ranged from 0=none to 10= very severe, where higher score indicated high disease activity. A negative value indicated improvement and a positive value indicated worsening.
Trial Locations
- Locations (50)
As0009 453
🇵🇱Elblag, Poland
As0009 201
🇨🇿Praha 4, Czechia
As0009 460
🇵🇱Wroclaw, Poland
As0009 156
🇧🇬Dobrich, Bulgaria
AS0009 6
🇺🇸Dallas, Texas, United States
As0009 30
🇺🇸Sarasota, Florida, United States
As0009 451
🇵🇱Poznan, Poland
As0009 450
🇵🇱Torun, Poland
As0009 400
🇭🇺Budapest, Hungary
As0009 101
🇨🇦Quebec City, Canada
As0009 150
🇧🇬Ruse, Bulgaria
As0009 207
🇨🇿Olomouc, Czechia
As0009 151
🇧🇬Plovdiv, Bulgaria
As0009 155
🇧🇬Plovdiv, Bulgaria
AS0009 1
🇺🇸Duncansville, Pennsylvania, United States
As0009 403
🇭🇺Budapest, Hungary
As0009 205
🇨🇿Brno, Czechia
As0009 304
🇩🇪Hamburg, Germany
As0009 210
🇨🇿Praha 11 Chodov, Czechia
As0009 208
🇨🇿Pardubice, Czechia
As0009 202
🇨🇿Praha, Czechia
As0009 203
🇨🇿Zlin, Czechia
As0009 211
🇨🇿Praha 3, Czechia
As0009 301
🇩🇪Ratingen, Germany
As0009 466
🇵🇱Bydgoszcz, Poland
As0009 461
🇵🇱Lublin, Poland
As0009 401
🇭🇺Veszprem, Hungary
As0009 456
🇵🇱Elblag, Poland
As0009 455
🇵🇱Krakow, Poland
As0009 467
🇵🇱Nowa Sol, Poland
As0009 454
🇵🇱Warszawa, Poland
As0009 457
🇵🇱Wroclaw, Poland
As0009 459
🇵🇱Warszawa, Poland
As0009 465
🇵🇱Wroclaw, Poland
As0009 601
🇷🇺Moscow, Russian Federation
As0009 604
🇷🇺Moscow, Russian Federation
As0009 600
🇷🇺Saint Petersburg, Russian Federation
As0009 607
🇷🇺Moscow, Russian Federation
As0009 608
🇷🇺Saint Petersburg, Russian Federation
As0009 606
🇷🇺Saint Petersburg, Russian Federation
As0009 610
🇷🇺Saint-petersburg, Russian Federation
As0009 801
🇪🇸A Coruna, Spain
As0009 800
🇪🇸Cordoba, Spain
As0009 803
🇪🇸Santiago de Compostela, Spain
As0009 700
🇺🇦Kyiv, Ukraine
As0009 707
🇺🇦Kyiv, Ukraine
As0009 705
🇺🇦Ternopil, Ukraine
As0009 708
🇺🇦Uzhgorod, Ukraine
As0009 706
🇺🇦Vinnytsia, Ukraine
As0009 704
🇺🇦Zaporizhzhia, Ukraine