Trial Outcomes & Findings for A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis (NCT NCT03215277)

Last Updated: 2023-07-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

From Baseline to Week 12

Results posted on

2023-07-27

Participant Flow

The study started to enroll study participants in October 2017 and concluded in May 2020.

The Participant Flow refers to the Randomized Set (RS).

Participant milestones

Participant milestones
Measure	Certolizumab Pegol 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.	Bimekizumab 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.
Overall Study STARTED	25	51
Overall Study COMPLETED	22	46
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol 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.	Bimekizumab 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.
Overall Study Adverse Event	2	3
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Participant was unable to attend clinic visit	0	1

Baseline Characteristics

A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol n=25 Participants 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.	Bimekizumab n=51 Participants 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.	Total Title n=76 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	47 Participants n=4 Participants	72 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants
Age, Continuous	39.7 years STANDARD_DEVIATION 8.2 • n=93 Participants	40.3 years STANDARD_DEVIATION 12.5 • n=4 Participants	40.1 years STANDARD_DEVIATION 11.2 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	44 Participants n=4 Participants	65 Participants n=27 Participants
Race/Ethnicity, Customized White	25 Participants n=93 Participants	51 Participants n=4 Participants	76 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	25 Participants n=93 Participants	51 Participants n=4 Participants	76 Participants n=27 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol (PPS) n=24 Participants 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).	Bimekizumab (PPS) n=46 Participants 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.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12	-1.83 scores on a scale Interval -2.11 to -1.55	-2.06 scores on a scale Interval -2.3 to -1.81

PRIMARY outcome

Timeframe: From Baseline until Safety Follow-Up Visit (up to Week 64)

Population: Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol (PPS) n=25 Participants 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).	Bimekizumab (PPS) n=51 Participants 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.
Number of Participants With Adverse Events (AE) During the Study Conduct	19 Participants	42 Participants

PRIMARY outcome

Timeframe: From Baseline until Safety Follow-Up Visit (up to Week 64)

Population: Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol (PPS) n=25 Participants 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).	Bimekizumab (PPS) n=51 Participants 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.
Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct	3 Participants	5 Participants

PRIMARY outcome

Timeframe: From Baseline until Safety Follow-Up Visit (up to Week 64)

Population: Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol (PPS) n=25 Participants 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).	Bimekizumab (PPS) n=51 Participants 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.
Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol (PPS) n=24 Participants 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).	Bimekizumab (PPS) n=46 Participants 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.
Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12	5 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol (PPS) n=24 Participants 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).	Bimekizumab (PPS) n=46 Participants 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.
Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12	11 Participants Interval 27.9 to 64.9	28 Participants Interval 46.5 to 73.6

Adverse Events

Certolizumab Pegol (SS)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 1 deaths

Bimekizumab (SS)

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Certolizumab Pegol (SS) n=25 participants at risk 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).	Bimekizumab (SS) n=51 participants at risk 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.
Cardiac disorders Coronary artery stenosis	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Eye disorders Uveitis	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Arthritis bacterial	4.0% 1/25 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	0.00% 0/51 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Pneumonia	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Lower respiratory tract infection	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Injury, poisoning and procedural complications Traumatic arthritis	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Injury, poisoning and procedural complications Lower limb fracture	4.0% 1/25 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	0.00% 0/51 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Nervous system disorders Myasthenia gravis	4.0% 1/25 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	0.00% 0/51 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Psychiatric disorders Completed suicide	4.0% 1/25 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	0.00% 0/51 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Renal and urinary disorders Acute kidney injury	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Vascular disorders Hypertensive crisis	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.

Other adverse events

Other adverse events
Measure	Certolizumab Pegol (SS) n=25 participants at risk 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).	Bimekizumab (SS) n=51 participants at risk 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.
Gastrointestinal disorders Diarrhoea	12.0% 3/25 • Number of events 3 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	0.00% 0/51 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Oral candidiasis	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	11.8% 6/51 • Number of events 8 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Oral herpes	8.0% 2/25 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	0.00% 0/51 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Influenza	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	5.9% 3/51 • Number of events 4 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Nasopharyngitis	24.0% 6/25 • Number of events 8 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	19.6% 10/51 • Number of events 12 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Pharyngitis	0.00% 0/25 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	9.8% 5/51 • Number of events 5 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Upper respiratory tract infection	4.0% 1/25 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	5.9% 3/51 • Number of events 3 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Infections and infestations Tonsillitis	8.0% 2/25 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Investigations Gamma-glutamyltransferase increased	4.0% 1/25 • Number of events 1 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	5.9% 3/51 • Number of events 5 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Investigations Alanine aminotransferase increased	8.0% 2/25 • Number of events 3 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Investigations Aspartate aminotransferase increased	8.0% 2/25 • Number of events 5 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	2.0% 1/51 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Musculoskeletal and connective tissue disorders Periarthritis	8.0% 2/25 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	0.00% 0/51 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	8.0% 2/25 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	7.8% 4/51 • Number of events 4 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.
Nervous system disorders Headache	8.0% 2/25 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.	3.9% 2/51 • Number of events 2 • From Baseline until Safety Follow-Up Visit (up to Week 64) 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.

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60