A Phase 2 interventional study of Bimekizumab and Certolizumab pegol in Ankylosing Spondylitis, sponsored by UCB Biopharma SRL. Completed at 34 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by UCB Biopharma SRL · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared to certolizumab pegol in the treatment of subjects with active ankylosing spondylitis (AS).
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 76 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject has moderate to severe active disease at the Screening Visit as defined by each of the following:
Exclusion Criteria:
Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
Subjects will receive several bimekizumab administrations on pre-defined time points. Placebo will be provided in this arm to mask the certolizumab pegol loading dose.
Drug: Bimekizumab · Other: Placebo
Subjects will receive several certolizumab pegol administrations on pre-defined time points.
Drug: Certolizumab pegol
One bimekizumab dose will be administered.
Also known as: UCB4940, BKZ
Two certolizumab pegol doses will be administered. One of these doses is a loading dose.
Also known as: CZP, Cimzia, CDP870
Placebo will be provided to maintain the blinding.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP \[mg/L\] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Posterior means and 95% credible intervals in each group are presented.
Time frame: From Baseline to Week 12
Number of Participants With Adverse Events (AE) During the Study Conduct
An AE was any untoward medical occurrence in a patient 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. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Time frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct
An SAE was any untoward medical occurrence that at any dose: - Resulted in death - Is life-threatening - Required in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment with parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardised the participants, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Time frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct
An AE was any untoward medical occurrence in a patient 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. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Time frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12
ASDAS-ID was defined by ASDAS \< 1.3. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP \[mg/L\] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score.
Time frame: Week 12
Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12
ASDAS-MI was defined by a reduction (improvement) from Baseline in ASDAS \>=2 units. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP \[mg/L\] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score.
Time frame: Baseline, Week 12
The study started to enroll study participants in October 2017 and concluded in May 2020.
| Milestone | Certolizumab Pegol | Bimekizumab |
|---|---|---|
| Started | 25 | 51 |
| Completed | 22 | 46 |
| Not completed | 3 | 5 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Participant was unable to attend clinic visit | 0 | 1 |
ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP \[mg/L\] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Posterior means and 95% credible intervals in each group are presented.
| scores on a scale | Certolizumab Pegol (PPS) | Bimekizumab (PPS) |
|---|---|---|
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 | -1.83 (-2.11 to -1.55) | -2.06 (-2.30 to -1.81) |
An AE was any untoward medical occurrence in a patient 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. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
| Participants | Certolizumab Pegol (SS) | Bimekizumab (SS) |
|---|---|---|
| Number of Participants With Adverse Events (AE) During the Study Conduct | 19 | 42 |
An SAE was any untoward medical occurrence that at any dose: - Resulted in death - Is life-threatening - Required in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment with parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardised the participants, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
| Participants | Certolizumab Pegol (SS) | Bimekizumab (SS) |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct | 3 | 5 |
An AE was any untoward medical occurrence in a patient 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. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
| Participants | Certolizumab Pegol (SS) | Bimekizumab (SS) |
|---|---|---|
| Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct | 3 | 3 |
ASDAS-ID was defined by ASDAS \< 1.3. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP \[mg/L\] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score.
| Participants | Certolizumab Pegol (PPS) | Bimekizumab (PPS) |
|---|---|---|
| Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12 | 5 | 11 |
ASDAS-MI was defined by a reduction (improvement) from Baseline in ASDAS \>=2 units. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP \[mg/L\] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score.
| Participants | Certolizumab Pegol (PPS) | Bimekizumab (PPS) |
|---|---|---|
| Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12 | 11 (27.9 to 64.9) | 28 (46.5 to 73.6) |
Collected over From Baseline until Safety Follow-Up Visit (up to Week 64). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Certolizumab Pegol (SS) | 1/25 (4%) | 3/25 (12%) | 16/25 (64%) |
| Bimekizumab (SS) | 0/51 (0%) | 5/51 (9.8%) | 27/51 (52.9%) |
| Event | Certolizumab Pegol (SS) | Bimekizumab (SS) |
|---|---|---|
| Arthritis bacterialInfections and infestations | 1/25 | 0/51 |
| Lower limb fractureInjury, poisoning and procedural complications | 1/25 | 0/51 |
| Myasthenia gravisNervous system disorders | 1/25 | 0/51 |
| Completed suicidePsychiatric disorders | 1/25 | 0/51 |
| Coronary artery stenosisCardiac disorders | 0/25 | 1/51 |
| UveitisEye disorders | 0/25 | 1/51 |
| PneumoniaInfections and infestations | 0/25 | 1/51 |
| Lower respiratory tract infectionInfections and infestations | 0/25 | 1/51 |
| Traumatic arthritisInjury, poisoning and procedural complications | 0/25 | 1/51 |
| Hand fractureInjury, poisoning and procedural complications | 0/25 | 1/51 |
| Event | Certolizumab Pegol (SS) | Bimekizumab (SS) |
|---|---|---|
| NasopharyngitisInfections and infestations | 6/25 | 10/51 |
| DiarrhoeaGastrointestinal disorders | 3/25 | 0/51 |
| Oral candidiasisInfections and infestations | 0/25 | 6/51 |
| PharyngitisInfections and infestations | 0/25 | 5/51 |
| Oral herpesInfections and infestations | 2/25 | 0/51 |
| TonsillitisInfections and infestations | 2/25 | 1/51 |
| Alanine aminotransferase increasedInvestigations | 2/25 | 1/51 |
| Aspartate aminotransferase increasedInvestigations | 2/25 | 1/51 |
| PeriarthritisMusculoskeletal and connective tissue disorders | 2/25 | 0/51 |
| Ankylosing spondylitisMusculoskeletal and connective tissue disorders | 2/25 | 4/51 |
Baseline Characteristics refer to Safety Set which consisted of all randomized study participants who received at least 1 dose (full or partial) of the investigational medicinal product (IMP).
| Age, Categorical(Participants) | Certolizumab Pegol | Bimekizumab | Total Title |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 47 | 72 |
| >=65 years | 0 | 4 | 4 |
| Age, Continuous(years) | Certolizumab Pegol | Bimekizumab | Total Title |
|---|---|---|---|
| Mean | 39.7 ± 8.2 | 40.3 ± 12.5 | 40.1 ± 11.2 |
| Sex: Female, Male(Participants) | Certolizumab Pegol | Bimekizumab | Total Title |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 21 | 44 | 65 |
| Race/Ethnicity, Customized(Participants) | Certolizumab Pegol | Bimekizumab | Total Title |
|---|---|---|---|
| White | 25 | 51 | 76 |
| Race/Ethnicity, Customized(Participants) | Certolizumab Pegol | Bimekizumab | Total Title |
|---|---|---|---|
| Not Hispanic or Latino | 25 | 51 | 76 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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