Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis (NCT NCT02696798)
NCT ID: NCT02696798
Last Updated: 2020-06-17
Results Overview
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
316 participants
Primary outcome timeframe
Week 16
Results posted on
2020-06-17
Participant Flow
Blinded Treatment Dosing Period (Week 0 to Week 16), Extended Treatment Period (Week 16 to Week 52) followed by post-treatment follow-up period occurring from last treatment visit (week 52), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.
Participants who completed study were eligible to enroll into a long-term study (I1F-MC-RHBY \[NCT03129100\]) for up to 2 additional years. Participants who terminate study RHBW early or who do not enroll into Study RHBY will complete the Post-Treatment Follow-Up (PTFU) Period in study RHBW.
Participant milestones
| Measure |
PBO/IXE
Blinded Treatment Dosing Period: Participants received placebo (PBO) every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab (IXE) 80 mg every four weeks (Q4W) or 80 mg Q2W at a 1:1 ratio with starting dose of 160 mg.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
|
IXE80Q4W/IXE80Q4W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
|
IXE80Q2W/IXE80Q2W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
|
|---|---|---|---|
|
Blinded Treatment Dosing Period
STARTED
|
104
|
114
|
98
|
|
Blinded Treatment Dosing Period
COMPLETED
|
93
|
99
|
90
|
|
Blinded Treatment Dosing Period
NOT COMPLETED
|
11
|
15
|
8
|
|
Extended Treatment Period
STARTED
|
93
|
98
|
90
|
|
Extended Treatment Period
COMPLETED
|
81
|
89
|
80
|
|
Extended Treatment Period
NOT COMPLETED
|
12
|
9
|
10
|
|
Post-treatment Follow-up Period
STARTED
|
5
|
34
|
22
|
|
Post-treatment Follow-up Period
COMPLETED
|
0
|
8
|
3
|
|
Post-treatment Follow-up Period
NOT COMPLETED
|
5
|
26
|
19
|
Reasons for withdrawal
| Measure |
PBO/IXE
Blinded Treatment Dosing Period: Participants received placebo (PBO) every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab (IXE) 80 mg every four weeks (Q4W) or 80 mg Q2W at a 1:1 ratio with starting dose of 160 mg.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
|
IXE80Q4W/IXE80Q4W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
|
IXE80Q2W/IXE80Q2W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
|
|---|---|---|---|
|
Blinded Treatment Dosing Period
Adverse Event
|
2
|
9
|
2
|
|
Blinded Treatment Dosing Period
Death
|
0
|
0
|
1
|
|
Blinded Treatment Dosing Period
Lack of Efficacy
|
2
|
1
|
1
|
|
Blinded Treatment Dosing Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Blinded Treatment Dosing Period
Physician Decision
|
0
|
1
|
0
|
|
Blinded Treatment Dosing Period
Withdrawal by Subject
|
7
|
3
|
4
|
|
Extended Treatment Period
Adverse Event
|
1
|
4
|
5
|
|
Extended Treatment Period
Lack of Efficacy
|
7
|
2
|
2
|
|
Extended Treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
|
Extended Treatment Period
Physician Decision
|
0
|
1
|
0
|
|
Extended Treatment Period
Withdrawal by Subject
|
3
|
2
|
3
|
|
Post-treatment Follow-up Period
Adverse Event
|
2
|
12
|
6
|
|
Post-treatment Follow-up Period
Lost to Follow-up
|
0
|
1
|
1
|
|
Post-treatment Follow-up Period
Lack of Efficacy
|
1
|
2
|
0
|
|
Post-treatment Follow-up Period
Withdrawal by Subject
|
2
|
8
|
12
|
|
Post-treatment Follow-up Period
Physician Decision
|
0
|
2
|
0
|
|
Post-treatment Follow-up Period
No progressive improvement
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
PBO/IXE
n=104 Participants
Blinded Treatment Dosing Period: Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab 80 mg Q4W or 80 mg Q2W at a 1:1 ratio with starting dose of 160 mg.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
Participants did not receive any intervention during Follow-up period
|
IXE80Q4W/IXE80Q4W
n=114 Participants
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
Participants did not receive any intervention during Follow-up period
|
IXE80Q2W/IXE80Q2W
n=98 Participants
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
Participants did not receive any intervention during Follow-up period
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
47.4 Years
STANDARD_DEVIATION 13.36 • n=7 Participants
|
44.2 Years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
46.1 Years
STANDARD_DEVIATION 12.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Finland
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants.
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
|
30.6 Percentage of participants
|
12.5 Percentage of participants
|
25.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving an ASAS20 Response
|
46.9 Percentage of Participants
|
29.8 Percentage of Participants
|
48.2 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are 1. Total back pain 2. Patient global 3. Peripheral pain/swelling 4. Duration of morning stiffness and 5. CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with treatment, geographic region, baseline CRP status, number of prior tumor necrosis factor inhibitor (TNFi), baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
|
-1.13 Units on a scale
Standard Error 0.103
|
-0.11 Units on a scale
Standard Error 0.099
|
-1.16 Units on a scale
Standard Error 0.094
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
|
23.5 Percentage of Participants
|
9.6 Percentage of Participants
|
21.9 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
-2.09 Units on a scale
Standard Error 0.221
|
-0.92 Units on a scale
Standard Error 0.212
|
-2.17 Units on a scale
Standard Error 0.202
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
The BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Participants respond to each question using an NRS scale (range 0 to 10). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
|
-1.92 Units on a scale
Standard Error 0.225
|
-0.64 Units on a scale
Standard Error 0.215
|
-1.69 Units on a scale
Standard Error 0.205
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
ASDAS is a composite index to assess disease activity in AS. ASDAS Inactive Disease is defined as a score of \<1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are 1. Total back pain 2. Patient global 3. Peripheral pain/swelling 4. Duration of morning stiffness and 5. CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving ASDAS Inactive Disease
|
5.1 Percentage of Participants
|
1.0 Percentage of Participants
|
3.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
ASDAS is a composite index to assess disease activity in AS. ASDAS \<2.1 defines moderate disease activity. The parameters used for the ASDAS (with CRP as acute phase reactant) are 1. Total back pain 2. Patient global 3. Peripheral pain/swelling 4. Duration of morning stiffness and 5. CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving ASDAS <2.1
|
16.3 Percentage of Participants
|
4.8 Percentage of Participants
|
17.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
SF-36 MCS
|
3.6514 Units on a scale
Standard Error 0.9921
|
2.7410 Units on a scale
Standard Error 0.9452
|
3.5099 Units on a scale
Standard Error 0.9074
|
—
|
|
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
SF-36 PCS
|
6.1223 Units on a scale
Standard Error 0.8465
|
1.3638 Units on a scale
Standard Error 0.8146
|
6.5785 Units on a scale
Standard Error 0.7763
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the patient needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in ASAS Health Index (ASAS HI)
|
-1.58 Units on a scale
Standard Error 0.352
|
-0.89 Units on a scale
Standard Error 0.338
|
-1.92 Units on a scale
Standard Error 0.322
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and week 16 ASSpiMRI score.
The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of the 23 disco-vertebral units (DVU) of the spine (from C2 to S1), capturing bone marrow edema. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema \[less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)\]. The composite score ranges from 0 to 69, with higher scores reflecting worse disease.LS mean was determined by analysis of covariance (ANCOVA) with treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=45 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=46 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=49 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)
|
-1.14 Units on a scale
Standard Error 0.414
|
1.03 Units on a scale
Standard Error 0.379
|
-0.92 Units on a scale
Standard Error 0.373
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and week 16 SPARCC MRI score.
MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Scoring was performed by central readers. LS mean was determined by ANCOVA with factors for treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=45 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=46 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=49 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
|
-3.97 Units on a scale
Standard Error 1.534
|
3.29 Units on a scale
Standard Error 1.402
|
-2.99 Units on a scale
Standard Error 1.384
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
|
-8.121 milligram per liter (mg/L)
Standard Error 2.8829
|
9.719 milligram per liter (mg/L)
Standard Error 2.7383
|
-11.096 milligram per liter (mg/L)
Standard Error 2.6190
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
BASMI is a combined index comprising of 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA). 1. Lateral Spinal Flexion 2. Tragus-to-wall distance 3. Lumbar Flexion (modified Schober) 4. Maximal intermalleolar distance and 5. Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
|
-0.217 Units on a scale
Standard Error 0.0981
|
-0.046 Units on a scale
Standard Error 0.0939
|
-0.349 Units on a scale
Standard Error 0.0897
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While patients have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Chest Expansion
|
0.27 centimeter(cm)
Standard Error 0.655
|
0.04 centimeter(cm)
Standard Error 0.644
|
1.27 centimeter(cm)
Standard Error 0.618
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Occiput to Wall Distance
|
-0.65 cm
Standard Error 0.399
|
0.35 cm
Standard Error 0.384
|
0.03 cm
Standard Error 0.365
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline MASES score \> 0.
The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=74 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=69 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=82 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
|
-2.2 Units on a scale
Standard Error 0.42
|
-1.9 Units on a scale
Standard Error 0.43
|
-1.8 Units on a scale
Standard Error 0.40
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline SPARCC Enthesitis score \> 0.
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=64 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=60 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=78 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score
|
-1.8 Units on a scale
Standard Error 0.45
|
-1.9 Units on a scale
Standard Error 0.44
|
-2.3 Units on a scale
Standard Error 0.40
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline TJC \> 0.
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=69 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=65 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=85 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Scores
|
-5.0 Tender Joint Count
Standard Error 0.79
|
-3.9 Tender Joint Count
Standard Error 0.79
|
-4.8 Tender Joint Count
Standard Error 0.69
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline SJC \> 0.
The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=44 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=45 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=48 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Scores
|
-3.0 Swollen Joint Count
Standard Error 0.54
|
-2.4 Swollen Joint Count
Standard Error 0.51
|
-2.6 Swollen Joint Count
Standard Error 0.49
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants With Anterior Uveitis
|
3.1 Percentage of Participants
|
0 Percentage of Participants
|
1.8 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
The fatigue severity NRS is a participant administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
|
-1.7 Units on a scale
Standard Error 0.25
|
-0.7 Units on a scale
Standard Error 0.24
|
-2.0 Units on a scale
Standard Error 0.23
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants.
The Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=114 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
|
-2.4 Units on a scale
Standard Error 0.52
|
-1.8 Units on a scale
Standard Error 0.50
|
-3.0 Units on a scale
Standard Error 0.48
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and week 16 WPAI-SpA score.
The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA with treatment, geographic region, baseline CRP status, number of prior TNFi and baseline value as fixed factors.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=96 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=99 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=112 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
Overall Work Impairment Score
|
-23.50 Units on a scale
Standard Error 4.225
|
-9.84 Units on a scale
Standard Error 3.733
|
-20.97 Units on a scale
Standard Error 4.016
|
—
|
|
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
Percentage of Activity Impairment
|
-18.4 Units on a scale
Standard Error 2.74
|
-10.1 Units on a scale
Standard Error 2.60
|
-16.5 Units on a scale
Standard Error 2.44
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from extended treatment period who had NSAID Intake at baseline.
ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, \& the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, higher the score greated the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=58 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=69 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=71 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
|
-2.33 Units on a scale
Standard Deviation 24.019
|
-9.84 Units on a scale
Standard Deviation 34.435
|
-5.52 Units on a scale
Standard Deviation 19.553
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a \>= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of \>= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=98 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=104 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=113 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-Ixekizumab Antibodies
|
4.1 Percentage of Participants
|
2.9 Percentage of Participants
|
7.1 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received study drug and have evaluable PK data.
Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.
Outcome measures
| Measure |
80 mg Q2W Ixekizumab
n=48 Participants
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
|
Placebo
n=60 Participants
Participants received placebo every 2 weeks by subcutaneous injection.
|
80 mg Q4W Ixekizumab
n=54 Participants
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
|
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
n=50 Participants
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
|
6.27 Microgram per milliliters (µg/mL)
Geometric Coefficient of Variation 158
|
2.10 Microgram per milliliters (µg/mL)
Geometric Coefficient of Variation 106
|
2.47 Microgram per milliliters (µg/mL)
Geometric Coefficient of Variation 101
|
8.52 Microgram per milliliters (µg/mL)
Geometric Coefficient of Variation 50
|
Adverse Events
80 mg Q2W Ixekizumab-Blinded Treatment Period
Serious events: 3 serious events
Other events: 25 other events
Deaths: 1 deaths
80 mg Q4W Ixekizumab-Blinded Treatment Period
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
PBO-Blinded Treatment Period
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
IXE80Q2W/IXE80Q2W-Extended Treatment Period
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
IXE80Q4W/IXE80Q4W-Extended Treatment Period
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
PBO/IXE-Extended Treatment Period
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
IXE80Q2W-Follow-up Period
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
IXE80Q4W-Follow-up Period
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
PBO-Follow-up Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
80 mg Q2W Ixekizumab-Blinded Treatment Period
n=98 participants at risk
Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
|
80 mg Q4W Ixekizumab-Blinded Treatment Period
n=114 participants at risk
Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
|
PBO-Blinded Treatment Period
n=104 participants at risk
Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
|
IXE80Q2W/IXE80Q2W-Extended Treatment Period
n=90 participants at risk
Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
|
IXE80Q4W/IXE80Q4W-Extended Treatment Period
n=98 participants at risk
Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
|
PBO/IXE-Extended Treatment Period
n=93 participants at risk
Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
|
IXE80Q2W-Follow-up Period
n=22 participants at risk
Participants did not receive any intervention during post-treatment follow-up period.
|
IXE80Q4W-Follow-up Period
n=34 participants at risk
Participants did not receive any intervention during post-treatment follow-up period.
|
PBO-Follow-up Period
n=5 participants at risk
Participants did not receive any intervention during post-treatment follow-up period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Atrial tachycardia
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/90 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Drop attacks
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Completed suicide
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
80 mg Q2W Ixekizumab-Blinded Treatment Period
n=98 participants at risk
Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
|
80 mg Q4W Ixekizumab-Blinded Treatment Period
n=114 participants at risk
Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
|
PBO-Blinded Treatment Period
n=104 participants at risk
Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
|
IXE80Q2W/IXE80Q2W-Extended Treatment Period
n=90 participants at risk
Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
|
IXE80Q4W/IXE80Q4W-Extended Treatment Period
n=98 participants at risk
Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
|
PBO/IXE-Extended Treatment Period
n=93 participants at risk
Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
|
IXE80Q2W-Follow-up Period
n=22 participants at risk
Participants did not receive any intervention during post-treatment follow-up period.
|
IXE80Q4W-Follow-up Period
n=34 participants at risk
Participants did not receive any intervention during post-treatment follow-up period.
|
PBO-Follow-up Period
n=5 participants at risk
Participants did not receive any intervention during post-treatment follow-up period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
4/98 • Number of events 4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.3%
6/114 • Number of events 6 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/90 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/98 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Injection site reaction
|
8.2%
8/98 • Number of events 21 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.6%
3/114 • Number of events 5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
5/90 • Number of events 14 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.0%
2/98 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 9 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
4/98 • Number of events 4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.4%
5/114 • Number of events 5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.9%
2/104 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.4%
4/90 • Number of events 4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
3/98 • Number of events 3 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
4/98 • Number of events 4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.9%
9/114 • Number of events 12 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
3/104 • Number of events 3 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.9%
8/90 • Number of events 10 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.1%
4/98 • Number of events 4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
3/98 • Number of events 3 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.1%
7/114 • Number of events 8 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.8%
4/104 • Number of events 4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/90 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.1%
4/98 • Number of events 4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.5%
1/22 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/98 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
5/90 • Number of events 5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.0%
2/98 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/23 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/23 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/17 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/17 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/9 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/114 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/90 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/98 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
3/98 • Number of events 3 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.9%
2/104 • Number of events 2 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
5/90 • Number of events 5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.1%
6/98 • Number of events 8 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/34 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/23 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/23 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/17 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/9 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/23 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/23 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/17 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/22 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/9 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up To 76 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60