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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001102-42 | EudraCT Number |
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This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks. |
|
| Bimekizumab Dose 1 | Experimental | 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. |
|
| Bimekizumab Dose 2 | Experimental | 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. |
|
| Bimekizumab Dose 3 | Experimental | Subjects will receive for 48 Weeks Bimekizumab Dose 3. |
|
| Bimekizumab Dose 4 | Experimental | Subjects will receive for 48 Weeks Bimekizumab Dose 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other |
| ||
| Bimekizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12 | 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), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 | The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI question 2 result) 0.058 x Duration of morning stiffness (BASDAI question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI question 3 result) 0.579 x (natural logarithm of the (hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score since CRP does not have a set upper limit. If one component for the ASDAS-CRP was missing at a given visit, that component was imputed by carrying the last observation forward, and the ASDAS-CRP was calculated accordingly. If the hs-CRP value was below 2 mg/L, then it was imputed as the constant value of 2 mg/L. |
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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:
Subjects must have at least 1 of the following:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273(UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| As0008 019 | Anniston | Alabama | 36207 | United States | ||
| As0008 007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32253184 | Result | 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. | |
| 35833532 |
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The study included a 28-Day Screening Period, followed by a Double-Blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post Week 48.
The Participant Flow refers to the Randomized Set and Dose-Blind Set.
The study started to enroll participants in October 2016 and concluded in August 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo during the 12 weeks Double-Blind Period. |
| FG001 | BKZ 16 mg | Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2018 | Oct 21, 2020 |
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Bimekizumab in different dosages. |
|
|
| From Baseline to Week 12 |
| Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12 | The ASAS20 response was defined as an improvement 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, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit]. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders. | Week 12 |
| Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12 | The ASAS 5/6 response was defined as at least 20% improvement in at least 5 of the 6 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP). Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders. | Week 12 |
| Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | The BASDAI is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random. | From Baseline to Week 12 |
| Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) | The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random. | From Baseline to Week 12 |
| Percentage of Participants With at Least One Adverse Event (AE) During the Study | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can 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. | From Screening until Safety Follow-Up Visit (up to Week 77) |
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
| From Screening until Safety Follow-Up Visit (up to Week 77) |
| Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Secondary Outcome Measure were summarized from the adverse event pages of the Case Report Forms. | From Screening until Safety Follow-Up Visit (up to Week 77) |
| La Jolla |
| California |
| 92037 |
| United States |
| As0008 009 | Upland | California | 91786 | United States |
| As0008 005 | Aventura | Florida | 33180 | United States |
| As0008 022 | Ormond Beach | Florida | 32174-11 | United States |
| As0008 030 | Sarasota | Florida | 34239 | United States |
| As0008 027 | Boston | Massachusetts | 02111 | United States |
| As0008 021 | Freehold | New Jersey | 07728 | United States |
| As0008 015 | Cleveland | Ohio | 44109-19 | United States |
| As0008 014 | Portland | Oregon | 97239 | United States |
| As0008 001 | Duncansville | Pennsylvania | 16635 | United States |
| As0008 020 | Austin | Texas | 78731 | United States |
| As0008 006 | Dallas | Texas | 75231 | United States |
| As0008 018 | Houston | Texas | 77030 | United States |
| As0008 002 | Seattle | Washington | 98122 | United States |
| As0008 156 | Dobrich | Bulgaria |
| As0008 151 | Plovdiv | Bulgaria |
| As0008 154 | Plovdiv | Bulgaria |
| As0008 155 | Plovdiv | Bulgaria |
| As0008 150 | Rousse | Bulgaria |
| As0008 101 | Québec | Canada |
| As0008 100 | Victoria | Canada |
| As0008 103 | Winnipeg | Canada |
| As0008 205 | Brno | Czechia |
| As0008 206 | Hustopeče | Czechia |
| As0008 207 | Olomouc | Czechia |
| As0008 208 | Pardubice | Czechia |
| As0008 201 | Prague | Czechia |
| As0008 202 | Prague | Czechia |
| As0008 209 | Prague | Czechia |
| As0008 210 | Prague | Czechia |
| As0008 211 | Prague | Czechia |
| As0008 203 | Zlín | Czechia |
| As0008 302 | Cologne | Germany |
| As0008 304 | Hamburg | Germany |
| As0008 308 | Hanover | Germany |
| As0008 303 | Herne | Germany |
| As0008 301 | Ratingen | Germany |
| As0008 400 | Budapest | Hungary |
| As0008 403 | Budapest | Hungary |
| As0008 402 | Debrecen | Hungary |
| As0008 401 | Veszprém | Hungary |
| As0008 466 | Bydgoszcz | Poland |
| As0008 453 | Elblag | Poland |
| As0008 456 | Elblag | Poland |
| As0008 455 | Krakow | Poland |
| As0008 461 | Lublin | Poland |
| As0008 467 | Nowa Sól | Poland |
| As0008 451 | Poznan | Poland |
| As0008 462 | Poznan | Poland |
| As0008 450 | Torun | Poland |
| As0008 454 | Warsaw | Poland |
| As0008 459 | Warsaw | Poland |
| As0008 457 | Wroclaw | Poland |
| As0008 460 | Wroclaw | Poland |
| As0008 465 | Wroclaw | Poland |
| As0008 601 | Moscow | Russia |
| As0008 604 | Moscow | Russia |
| As0008 605 | Moscow | Russia |
| As0008 607 | Moscow | Russia |
| As0008 600 | Saint Petersburg | Russia |
| As0008 606 | Saint Petersburg | Russia |
| As0008 608 | Saint Petersburg | Russia |
| As0008 609 | Saint Petersburg | Russia |
| As0008 610 | Saint Petersburg | Russia |
| As0008 801 | A Coruña | Spain |
| As0008 800 | Córdoba | Spain |
| As0008 803 | Santiago de Compostela | Spain |
| As0008 700 | Kiev | Ukraine |
| As0008 707 | Kyiv | Ukraine |
| As0008 705 | Ternopil | Ukraine |
| As0008 708 | Uzhhorod | Ukraine |
| As0008 706 | Vinnytsia | Ukraine |
| As0008 704 | Zaporizhya | Ukraine |
| Result |
| Robinson PC, Machado PM, Haroon N, Gensler LS, Reveille JD, Taieb V, Vaux T, Fleurinck C, Oortgiesen M, de Peyrecave N, Deodhar A. Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study. ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14. |
| 41807031 | Derived | Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174. |
| 40194794 | Derived | Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026. |
| 39890205 | Derived | Deodhar A, Navarro-Compan V, Poddubnyy D, Gensler LS, Ramiro S, Tomita T, Marzo-Ortega H, Fleurinck C, Vaux T, Massow U, de Peyrecave N, van der Heijde D, Baraliakos X. Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension. RMD Open. 2025 Jan 31;11(1):e005081. doi: 10.1136/rmdopen-2024-005081. |
| FG002 | BKZ 64 mg | Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. |
| FG003 | BKZ 160 mg | Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. |
| FG004 | BKZ 320 mg | Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. |
| FG005 | Placebo - BKZ 160 mg | After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period. |
| FG006 | Placebo - BKZ 320 mg | After the 12 weeks Double-Blind Period participants randomized to placebo were re-randomized to receive bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) for 36 weeks in the Dose-Blind Period |
| FG007 | BKZ 16 mg - BKZ 160 mg | After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. |
| FG008 | BKZ 16 mg - BKZ 320 mg | After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 16 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. |
| FG009 | BKZ 64 mg - BKZ 160 mg | After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 160 mg Q4W for 36 weeks in the Dose-Blind Period. |
| FG010 | BKZ 64 mg - BKZ 320 mg | After the 12 weeks Double-Blind Period participants randomized to bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) were re-randomized to receive BKZ 320 mg Q4W for 36 weeks in the Dose-Blind Period. |
| FG011 | BKZ 160 mg - BKZ 160 mg | Participants randomized to bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 160 mg Q4W in the 36 weeks Dose-Blind Period. |
| FG012 | BKZ 320 mg - BKZ 320 mg | Participants randomized to bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) in the 12 weeks Double-Blind Period, continued to receive BKZ 320 mg Q4W in the 36 weeks Dose-Blind Period. |
| Completed Double-Blind Period |
|
| Completed Week 12 - Started Dose-Blind |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Dose-Blind Period |
|
|
The Baseline Characteristics refer to the Full Analysis Set (FAS), which consisted all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo during the 12 weeks Double-Blind Period. |
| BG001 | BKZ 16 mg | Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. |
| BG002 | BKZ 64 mg | Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period. |
| BG003 | BKZ 160 mg | Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. |
| BG004 | BKZ 320 mg | Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period. |
| BG005 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12 | 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), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders. | The FAS consisted of all randomized participants who received at least 1 dose of investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 | The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI question 2 result) 0.058 x Duration of morning stiffness (BASDAI question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI question 3 result) 0.579 x (natural logarithm of the (hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score since CRP does not have a set upper limit. If one component for the ASDAS-CRP was missing at a given visit, that component was imputed by carrying the last observation forward, and the ASDAS-CRP was calculated accordingly. If the hs-CRP value was below 2 mg/L, then it was imputed as the constant value of 2 mg/L. | The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline. | Posted | Least Squares Mean | Standard Error | scores on a scale | From Baseline to Week 12 |
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| Secondary | Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12 | The ASAS20 response was defined as an improvement 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, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit]. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders. | The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12 | The ASAS 5/6 response was defined as at least 20% improvement in at least 5 of the 6 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration), spinal mobility (lateral spinal flexion) and high sensitivity C-reactive protein (hs-CRP). Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders. | The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | The BASDAI is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random. | The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline. | Posted | Least Squares Mean | Standard Error | scores on a scale | From Baseline to Week 12 |
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| Secondary | Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) | The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Note: Missing data was imputed using multiple imputation based on the Markov-Chain Monte Carlo method for the intermittent missing data, followed by monotone regression for the monotone missing data assuming missing at random. | The FAS consisted of all randomized participants who received at least 1 dose of IMP and had a valid measurement of the primary efficacy variable at Baseline. | Posted | Least Squares Mean | Standard Error | scores on a scale | From Baseline to Week 12 |
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| Secondary | Percentage of Participants With at Least One Adverse Event (AE) During the Study | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can 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. | The SS consisted of all randomized participants who received at least 1 dose of IMP. | Posted | Number | percentage of participants | From Screening until Safety Follow-Up Visit (up to Week 77) |
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| Secondary | Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study | A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
| The SS consisted of all randomized participants who received at least 1 dose of IMP. | Posted | Number | percentage of participants | From Screening until Safety Follow-Up Visit (up to Week 77) |
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| Secondary | Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study | An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Secondary Outcome Measure were summarized from the adverse event pages of the Case Report Forms. | The SS consisted of all randomized participants who received at least 1 dose of IMP. | Posted | Number | percentage of participants | From Screening until Safety Follow-Up Visit (up to Week 77) |
|
Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (SS) - up to Wk 12 | This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS). | 0 | 60 | 2 | 60 | 2 | 60 |
| EG001 | BKZ 16 mg (SS) - up to Wk 12 | This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. | 0 | 61 | 0 | 61 | 2 | 61 |
| EG002 | BKZ 64 mg (SS) - up to Wk 12 | This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. | 0 | 58 | 2 | 58 | 4 | 58 |
| EG003 | BKZ 160 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. | 1 | 149 | 5 | 149 | 42 | 149 |
| EG004 | BKZ 320 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. | 0 | 150 | 6 | 150 | 56 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Inner ear disorder | Ear and labyrinth disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral candidiasis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2018 | Oct 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Sponsor decision |
|
| Meeting exclusion criteria 9 |
|
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| White |
|
| Other/Mixed |
|
For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure. |
| Regression, Logistic |
| =0.040 |
The p-values were displayed as nominal p-values. |
| Odds Ratio (OR) |
| 2.6 |
| 2-Sided |
| 95 |
| 1.04 |
| 6.48 |
| Other |
The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant. |
| For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure. | Regression, Logistic | =0.001 | The p-values were displayed as nominal p-values. | Odds Ratio (OR) | 4.5 | 2-Sided | 95 | 1.83 | 10.86 | Other | The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant. |
| For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure. | Regression, Logistic | <0.001 | The p-values were displayed as nominal p-values. | Odds Ratio (OR) | 5.5 | 2-Sided | 95 | 2.27 | 13.48 | Other | The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant. |
| For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure. | Regression, Logistic | <0.001 | The p-values were displayed as nominal p-values. | Odds Ratio (OR) | 5.3 | 2-Sided | 95 | 2.19 | 12.92 | Other | The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant. |
Participants received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS).
| OG002 | BKZ 64 mg (FAS) | Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS). |
| OG003 | BKZ 160 mg (FAS) | Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
| OG004 | BKZ 320 mg (FAS) | Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
|
|
|
| BKZ 64 mg (FAS) |
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS). |
| OG003 | BKZ 160 mg (FAS) | Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
| OG004 | BKZ 320 mg (FAS) | Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
|
|
|
| OG003 | BKZ 160 mg (FAS) | Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
| OG004 | BKZ 320 mg (FAS) | Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
|
|
|
| OG002 | BKZ 64 mg (FAS) | Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS). |
| OG003 | BKZ 160 mg (FAS) | Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
| OG004 | BKZ 320 mg (FAS) | Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
|
|
|
| BKZ 64 mg (FAS) |
Participants received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period, forming the Full Analysis Set (FAS). |
| OG003 | BKZ 160 mg (FAS) | Participants received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
| OG004 | BKZ 320 mg (FAS) | Participants received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) during the 12 weeks Double-Blind Period followed by the same dose during the 36 weeks Dose-Blind Period, forming the Full Analysis Set (FAS). |
|
|
|
| OG003 | BKZ 160 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. |
| OG004 | BKZ 320 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. |
|
|
This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS.
| OG003 | BKZ 160 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. |
| OG004 | BKZ 320 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. |
|
|
| OG003 | BKZ 160 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. |
| OG004 | BKZ 320 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. |
|
|