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Trial record 1 of 1 for:    AS0013
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A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT03215277
Recruitment Status : Completed
First Posted : July 12, 2017
Results First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: Bimekizumab
Drug: Certolizumab pegol
Other: Placebo
Enrollment 76
Recruitment Details The study started to enroll study participants in October 2017 and concluded in May 2020.
Pre-assignment Details The Participant Flow refers to the Randomized Set (RS).
Arm/Group Title Certolizumab Pegol Bimekizumab
Hide Arm/Group Description Participants received certolizumab pegol (CZP) 400 milligrams (mg) subcutaneously (sc) every 2 weeks (Q2W) at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg every 4 weeks (Q4W) from Week 12 to Week 44. Participants received bimekizumab (BKZ) 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4.
Period Title: Overall Study
Started 25 51
Completed 22 46
Not Completed 3 5
Reason Not Completed
Adverse Event             2             3
Death             1             0
Lost to Follow-up             0             1
Participant was unable to attend clinic visit             0             1
Arm/Group Title Certolizumab Pegol Bimekizumab Total Title
Hide Arm/Group Description Participants received certolizumab pegol (CZP) 400 milligrams (mg) subcutaneously (sc) every 2 weeks (Q2W) at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg every 4 weeks (Q4W) from Week 12 to Week 44. Participants received bimekizumab (BKZ) 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. [Not Specified]
Overall Number of Baseline Participants 25 51 76
Hide Baseline Analysis Population Description
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 51 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
47
  92.2%
72
  94.7%
>=65 years
0
   0.0%
4
   7.8%
4
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 51 participants 76 participants
39.7  (8.2) 40.3  (12.5) 40.1  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 51 participants 76 participants
Female
4
  16.0%
7
  13.7%
11
  14.5%
Male
21
  84.0%
44
  86.3%
65
  85.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 51 participants 76 participants
White
25
 100.0%
51
 100.0%
76
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 51 participants 76 participants
Not Hispanic or Latino
25
 100.0%
51
 100.0%
76
 100.0%
1.Primary Outcome
Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS) consisted of all study participants in the Full Analysis Set who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Certolizumab Pegol (PPS) Bimekizumab (PPS)
Hide Arm/Group Description:
Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Per Protocol Set (PPS).
Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the PPS.
Overall Number of Participants Analyzed 24 46
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
-1.83
(-2.11 to -1.55)
-2.06
(-2.30 to -1.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Certolizumab Pegol (PPS), Bimekizumab (PPS)
Comments Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. The mean posterior difference and 95% credible interval were presented for the BKZ vs CZP comparison.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Posterior Difference
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.14 to 0.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Certolizumab Pegol (PPS), Bimekizumab (PPS)
Comments Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr[Diff>0%](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter PR[Diff > 0%](%)
Estimated Value 88.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Adverse Events (AE) During the Study Conduct
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.
Arm/Group Title Certolizumab Pegol (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Safety Set (SS).
Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the SS.
Overall Number of Participants Analyzed 25 51
Measure Type: Count of Participants
Unit of Measure: Participants
19
  76.0%
42
  82.4%
3.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.
Arm/Group Title Certolizumab Pegol (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Safety Set (SS).
Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the SS.
Overall Number of Participants Analyzed 25 51
Measure Type: Count of Participants
Unit of Measure: Participants
3
  12.0%
5
   9.8%
4.Primary Outcome
Title Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.
Arm/Group Title Certolizumab Pegol (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Safety Set (SS).
Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the SS.
Overall Number of Participants Analyzed 25 51
Measure Type: Count of Participants
Unit of Measure: Participants
3
  12.0%
3
   5.9%
5.Secondary Outcome
Title Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set (PPS) consisted of all study participants in the Full Analysis Set who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Certolizumab Pegol (PPS) Bimekizumab (PPS)
Hide Arm/Group Description:
Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Per Protocol Set (PPS).
Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the PPS.
Overall Number of Participants Analyzed 24 46
Measure Type: Count of Participants
Unit of Measure: Participants
5
  20.8%
11
  23.9%
6.Secondary Outcome
Title Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set (PPS) consisted of all study participants in the Full Analysis Set who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Certolizumab Pegol (PPS) Bimekizumab (PPS)
Hide Arm/Group Description:
Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Per Protocol Set (PPS).
Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the PPS.
Overall Number of Participants Analyzed 24 46
Measure Type: Count of Participants
Unit of Measure: Participants
11
  45.8%
28
  60.9%
Time Frame From Baseline until Safety Follow-Up Visit (up to Week 64)
Adverse Event Reporting Description 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.
 
Arm/Group Title Certolizumab Pegol (SS) Bimekizumab (SS)
Hide Arm/Group Description Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Safety Set (SS). Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the SS.
All-Cause Mortality
Certolizumab Pegol (SS) Bimekizumab (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/25 (4.00%)      0/51 (0.00%)    
Hide Serious Adverse Events
Certolizumab Pegol (SS) Bimekizumab (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/25 (12.00%)      5/51 (9.80%)    
Cardiac disorders     
Coronary artery stenosis * 1  0/25 (0.00%)  0 1/51 (1.96%)  1
Eye disorders     
Uveitis * 1  0/25 (0.00%)  0 1/51 (1.96%)  1
Infections and infestations     
Arthritis bacterial * 1  1/25 (4.00%)  1 0/51 (0.00%)  0
Pneumonia * 1  0/25 (0.00%)  0 1/51 (1.96%)  2
Lower respiratory tract infection * 1  0/25 (0.00%)  0 1/51 (1.96%)  1
Injury, poisoning and procedural complications     
Traumatic arthritis * 1  0/25 (0.00%)  0 1/51 (1.96%)  1
Hand fracture * 1  0/25 (0.00%)  0 1/51 (1.96%)  1
Lower limb fracture * 1  1/25 (4.00%)  1 0/51 (0.00%)  0
Nervous system disorders     
Myasthenia gravis * 1  1/25 (4.00%)  1 0/51 (0.00%)  0
Psychiatric disorders     
Completed suicide * 1  1/25 (4.00%)  1 0/51 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury * 1  0/25 (0.00%)  0 1/51 (1.96%)  1
Vascular disorders     
Hypertensive crisis * 1  0/25 (0.00%)  0 1/51 (1.96%)  1
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol (SS) Bimekizumab (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/25 (64.00%)      27/51 (52.94%)    
Gastrointestinal disorders     
Diarrhoea * 1  3/25 (12.00%)  3 0/51 (0.00%)  0
Infections and infestations     
Oral candidiasis * 1  0/25 (0.00%)  0 6/51 (11.76%)  8
Oral herpes * 1  2/25 (8.00%)  2 0/51 (0.00%)  0
Influenza * 1  0/25 (0.00%)  0 3/51 (5.88%)  4
Nasopharyngitis * 1  6/25 (24.00%)  8 10/51 (19.61%)  12
Pharyngitis * 1  0/25 (0.00%)  0 5/51 (9.80%)  5
Upper respiratory tract infection * 1  1/25 (4.00%)  1 3/51 (5.88%)  3
Tonsillitis * 1  2/25 (8.00%)  2 1/51 (1.96%)  1
Investigations     
Gamma-glutamyltransferase increased * 1  1/25 (4.00%)  1 3/51 (5.88%)  5
Alanine aminotransferase increased * 1  2/25 (8.00%)  3 1/51 (1.96%)  2
Aspartate aminotransferase increased * 1  2/25 (8.00%)  5 1/51 (1.96%)  2
Musculoskeletal and connective tissue disorders     
Periarthritis * 1  2/25 (8.00%)  2 0/51 (0.00%)  0
Ankylosing spondylitis * 1  2/25 (8.00%)  2 4/51 (7.84%)  4
Nervous system disorders     
Headache * 1  2/25 (8.00%)  2 2/51 (3.92%)  2
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: 001 844 599 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03215277    
Other Study ID Numbers: AS0013
2017-000957-37 ( EudraCT Number )
First Submitted: July 5, 2017
First Posted: July 12, 2017
Results First Submitted: May 19, 2023
Results First Posted: July 27, 2023
Last Update Posted: July 27, 2023