Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis (NCT NCT02696785)

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 in at least 3 of the following 4 domains without any worsening in the remaining domains. 1. Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (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

341 participants

Primary outcome timeframe

Week 16

Results posted on

2019-11-19

Participant Flow

Blinded treatment period (Week 0 to Week 16), followed by extended treatment period (Week 16 to Week 52), followed by post treatment period for a maximum of 24 weeks. Washout period occurred for only Adalimumab group for 6 weeks (Week 14 to Week 20).

Participants who completed study were eligible to enroll into a long-term study (Study I1F-MC-RHBY \[RHBY\]) for up to 2 additional years. Participants that do not enroll into study RHBY will complete the Post-Treatment Follow-Up Period.

Participant milestones

Participant milestones
Measure	PBO/IXE Blinded Treatment Period: Participants received placebo every two weeks by subcutaneous injection. Extended Treatment Period: Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either every two weeks (Q2W) or every four weeks (Q4W) by subcutaneous (SC) injection during extended treatment period. Participants did not receive any intervention during Follow-up period.	ADA/PBO/IXE Blinded Treatment Period:Participants received 40mg Adalimumab every two weeks by SC injection. Washout Period: Participants received placebo for 6 weeks. Extended Treatment Period:Participants received 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period. Participants did not receive any intervention during Follow-up period.	IXE80Q2W/IXE80Q2W Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded \& extension treatment period. Participants did not receive any intervention during Follow-up period.	IXE80Q4W/IXE80Q4W Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded \& extension treatment period. Participants did not receive any intervention during Follow-up period.
Blinded Treatment Period STARTED	87	90	83	81
Blinded Treatment Period Received at Least One Dose of Study Drug	86	90	83	81
Blinded Treatment Period COMPLETED	86	88	79	78
Blinded Treatment Period NOT COMPLETED	1	2	4	3
Washout Period STARTED	0	88	0	0
Washout Period COMPLETED	0	86	0	0
Washout Period NOT COMPLETED	0	2	0	0
Extended Treatment Period STARTED	86	86	79	78
Extended Treatment Period COMPLETED	83	80	74	72
Extended Treatment Period NOT COMPLETED	3	6	5	6
Follow-up Period STARTED	1	0	24	16
Follow-up Period COMPLETED	0	0	11	8
Follow-up Period NOT COMPLETED	1	0	13	8

Reasons for withdrawal

Reasons for withdrawal
Measure	PBO/IXE Blinded Treatment Period: Participants received placebo every two weeks by subcutaneous injection. Extended Treatment Period: Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either every two weeks (Q2W) or every four weeks (Q4W) by subcutaneous (SC) injection during extended treatment period. Participants did not receive any intervention during Follow-up period.	ADA/PBO/IXE Blinded Treatment Period:Participants received 40mg Adalimumab every two weeks by SC injection. Washout Period: Participants received placebo for 6 weeks. Extended Treatment Period:Participants received 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period. Participants did not receive any intervention during Follow-up period.	IXE80Q2W/IXE80Q2W Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded \& extension treatment period. Participants did not receive any intervention during Follow-up period.	IXE80Q4W/IXE80Q4W Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded \& extension treatment period. Participants did not receive any intervention during Follow-up period.
Blinded Treatment Period Adverse Event	0	1	3	0
Blinded Treatment Period Withdrawal by Subject	0	1	1	2
Blinded Treatment Period Lack of Efficacy	0	0	0	1
Blinded Treatment Period Screen Failure	1	0	0	0
Washout Period Withdrawal by Subject	0	1	0	0
Washout Period Lack of Efficacy	0	1	0	0
Extended Treatment Period Adverse Event	2	3	2	1
Extended Treatment Period Lack of Efficacy	0	1	0	0
Extended Treatment Period Withdrawal by Subject	1	2	3	5
Follow-up Period Adverse Event	0	0	8	2
Follow-up Period Lost to Follow-up	0	0	0	1
Follow-up Period Lack of Efficacy	0	0	0	1
Follow-up Period Withdrawal by Subject	1	0	5	4

Baseline Characteristics

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PBO/IXE n=86 Participants Participants received placebo every two weeks by subcutaneous injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by subcutaneous injection during extension treatment period.	ADA/IXE n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period.	IXE80Q2W/IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded \& extension treatment period.	IXE80Q4W/IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded \& extension treatment period.	Total n=340 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 12.01 • n=5 Participants	41.8 years STANDARD_DEVIATION 11.44 • n=7 Participants	41.3 years STANDARD_DEVIATION 11.17 • n=5 Participants	41.0 years STANDARD_DEVIATION 12.13 • n=4 Participants	41.7 years STANDARD_DEVIATION 11.66 • n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	13 Participants n=4 Participants	64 Participants n=21 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	73 Participants n=7 Participants	64 Participants n=5 Participants	68 Participants n=4 Participants	276 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	34 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants	74 Participants n=7 Participants	68 Participants n=5 Participants	66 Participants n=4 Participants	275 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	31 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) Asian	28 Participants n=5 Participants	29 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	107 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	57 Participants n=7 Participants	52 Participants n=5 Participants	52 Participants n=4 Participants	213 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment South Korea	10 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	47 Participants n=21 Participants
Region of Enrollment Netherlands	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment United States	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment Czechia	14 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	54 Participants n=21 Participants
Region of Enrollment Japan	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment Taiwan	13 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	51 Participants n=21 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment Hungary	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Mexico	8 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
Region of Enrollment Poland	16 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	16 Participants n=4 Participants	62 Participants n=21 Participants
Region of Enrollment Russia	12 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	48 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 16

Population: 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 in at least 3 of the following 4 domains without any worsening in the remaining domains. 1. Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (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

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response	18.4 percentage of participants	35.6 percentage of participants	48.1 percentage of participants	51.8 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants.

ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units in ≥3 of 4 following 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 range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using NRS scale (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

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Percentage of Participants Achieving an ASAS20 Response	40.2 percentage of participants	58.9 percentage of participants	64.2 percentage of participants	68.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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 the following: 1. Total back pain 2. Patient global 3. Peripheral pain/swelling 4. Duration of morning stiffness 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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)	-0.46 score on a scale Standard Error 0.099	-1.30 score on a scale Standard Error 0.096	-1.43 score on a scale Standard Error 0.102	-1.37 score on a scale Standard Error 0.101

SECONDARY outcome

Timeframe: Week 16

Population: 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 measuring discomfort, pain, and fatigue. 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). BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response	17.2 percentage of participants	32.2 percentage of participants	42.0 percentage of participants	43.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants.

The BASFI is a participant-reported assessment that establishes a participants functional baseline and subsequent response to treatment. To complete the BASFI, a participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants respond to each question using an NRS scale (range 0 to 10) with a higher score indicating worse function. The participants final BASFI score is the mean of the 10 item scores has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)	-1.16 score on a scale Standard Error 0.215	-2.14 score on a scale Standard Error 0.209	-2.39 score on a scale Standard Error 0.222	-2.43 score on a scale Standard Error 0.219

SECONDARY outcome

Timeframe: Week 16

Population: 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 the following: 1. Total back pain 2. Patient global 3. Peripheral pain/swelling 4. Duration of morning stiffness 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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. ASDAS Inactive Disease is defined as a score of \<1.3.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Percentage of Participants Achieving ASDAS Inactive Disease	2.3 percentage of Participants	15.6 percentage of Participants	16.0 percentage of Participants	10.8 percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with baseline and week 16 Berlin score.

The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of 23 disco-vertebral units (DVU). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) are scored for 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. Least Squares (LS) Mean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=82 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=78 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=76 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg 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)	-0.15 score on a scale Standard Error 0.323	-2.92 score on a scale Standard Error 0.314	-2.77 score on a scale Standard Error 0.328	-2.54 score on a scale Standard Error 0.330

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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 calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg 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 MCS	2.1229 score on a scale Standard Error 0.8431	2.5550 score on a scale Standard Error 0.8225	2.7502 score on a scale Standard Error 0.8763	2.5696 score on a scale Standard Error 0.8650
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores PCS	3.6432 score on a scale Standard Error 0.7530	6.9005 score on a scale Standard Error 0.7310	7.6952 score on a scale Standard Error 0.7768	7.9686 score on a scale Standard Error 0.7665

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants.

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 one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in ASAS Health Index (ASAS HI)	-1.25 score on a scale Standard Error 0.300	-2.30 score on a scale Standard Error 0.292	-2.36 score on a scale Standard Error 0.311	-2.74 score on a scale Standard Error 0.306

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants.

High sensitivity CRP is the measure of acute phase reactant. It will be measured with a high sensitivity assay at the central laboratory to help assess the effect of Ixekizumab on disease activity. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, visit and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)	1.426 Milliragm per Litre (mg/mL) Standard Error 1.9244	-7.202 Milliragm per Litre (mg/mL) Standard Error 1.8688	-5.209 Milliragm per Litre (mg/mL) Standard Error 1.9803	-6.565 Milliragm per Litre (mg/mL) Standard Error 1.9582

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants.

The BASMI is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with rad-axSpA. 1. Lateral spinal flexion 2. Tragus-to-wall distance 3. Lumbar flexion (modified Schrober) 4. Maximal intermalleolar distance 5. Cervical rotation. The BASMI includes these 5 measurements that are each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. The higher the BASMI score the more severe the participants limitation of movement due to their AS. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)	-0.080 score on a scale Standard Error 0.0826	-0.447 score on a scale Standard Error 0.0800	-0.502 score on a scale Standard Error 0.0858	-0.408 score on a scale Standard Error 0.0840

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All Randomized Participants.

While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Chest Expansion	0.06 Centimeters (cm) Standard Error 0.152	0.70 Centimeters (cm) Standard Error 0.148	0.49 Centimeters (cm) Standard Error 0.158	0.67 Centimeters (cm) Standard Error 0.155

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Occiput to Wall Distance	-0.06 cm Standard Error 0.232	-0.72 cm Standard Error 0.225	-0.69 cm Standard Error 0.240	-0.73 cm Standard Error 0.236

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with baseline and week 16 SPARCC score.

Both left and right SIJ are scored for bone marrow edema.Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=82 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=78 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=77 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score	0.92 score on a scale Standard Error 0.582	-4.21 score on a scale Standard Error 0.568	-3.97 score on a scale Standard Error 0.590	-4.25 score on a scale Standard Error 0.591

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=51 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=49 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=50 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)	-2.1 score on a scale Standard Error 0.34	-2.6 score on a scale Standard Error 0.34	-2.3 score on a scale Standard Error 0.36	-2.4 score on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with baseline SPARCC 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=40 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=40 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=35 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in SPARCC Enthesitis Score	-2.1 score on a scale Standard Error 0.40	-2.9 score on a scale Standard Error 0.40	-2.7 score on a scale Standard Error 0.40	-2.6 score on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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 participants body. The 46 joints are assessed and classified as tender or not tender. sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=49 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=44 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=45 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC)	-2.0 score on a scale Standard Error 0.53	-2.2 score on a scale Standard Error 0.55	-2.5 score on a scale Standard Error 0.58	-3.3 score on a scale Standard Error 0.58

SECONDARY outcome

Timeframe: Baseline through Week 16

Population: 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

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Number of Participants With Anterior Uveitis or Uveitis Flares	0 Count of Participants	0 Count of Participants	1 Count of Participants	0 Count of Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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 one number that describes their worst level of fatigue during the previous 24 hours. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score	-1.4 score on a scale Standard Error 0.23	-2.2 score on a scale Standard Error 0.23	-2.5 score on a scale Standard Error 0.24	-2.1 score on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants.

The 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. Participants report the number 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)	-1.5 score on a scale Standard Error 0.41	-2.7 score on a scale Standard Error 0.40	-2.5 score on a scale Standard Error 0.43	-3.0 score on a scale Standard Error 0.42

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants.

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. Greater scores indicate greater impairment and less productivity. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores Overall Work Impairment Score	-17.82 score on a scale Standard Error 3.254	-21.44 score on a scale Standard Error 2.921	-21.36 score on a scale Standard Error 3.061	-24.06 score on a scale Standard Error 3.299
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores Percentage of Activity Impairment	-14.1 score on a scale Standard Error 2.28	-21.1 score on a scale Standard Error 2.22	-23.0 score on a scale Standard Error 2.35	-23.4 score on a scale Standard Error 2.30

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Participants in Extended Treatment Period Population 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).. ASAS-NSAID score=(equivalent NSAID score)x(days of intake during PI)x(days per week)/(PI in days). Higher scores indicate greater NSAIDs intake. 0= no intake, 100 = equivalent NSAID intake.

Outcome measures

Outcome measures
Measure	Placebo n=78 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=80 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=71 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=76 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score	-10.28 score on a scale Standard Deviation 27.472	-5.91 score on a scale Standard Deviation 20.861	-7.62 score on a scale Standard Deviation 25.430	-9.91 score on a scale Standard Deviation 27.940

SECONDARY outcome

Timeframe: Week 16

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=90 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=81 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=83 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Number of Participants With Anti Ixekizumab Antibodies	2 Participants	5 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants who received at least one dose of Ixekizumab.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=39 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=45 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=38 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss)	3.56 microgram per millilitre (μg/mL) Geometric Coefficient of Variation 56	3.88 microgram per millilitre (μg/mL) Geometric Coefficient of Variation 55	11.6 microgram per millilitre (μg/mL) Geometric Coefficient of Variation 54	11.3 microgram per millilitre (μg/mL) Geometric Coefficient of Variation 43

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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 participants body. The 44 joints are assessed and classified as swollen or not swollen. "sum of all joints checked to be swollen" divided by "number of evaluable joints" and then multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=23 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=24 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=22 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC)	-1.7 score on a scale Standard Error 0.55	-2.7 score on a scale Standard Error 0.53	-3.6 score on a scale Standard Error 0.53	-2.7 score on a scale Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: All randomized participants with baseline and week 16 SPARCC MRI score for spine.

MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVUs) of the spine (from C2 to S1) are scored for bone marrow edema. A single DVU has a scoring range of 0 to 18, bringing the maximum total score to 414, with higher scores reflecting worse disease. Scoring was performed by central readers. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Participants received placebo every two weeks by subcutaneous injection.	Adalimumab n=82 Participants Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q4W n=78 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	IXE80Q2W n=76 Participants Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg 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)	-1.51 score on a scale Standard Error 1.147	-11.57 score on a scale Standard Error 1.113	-11.02 score on a scale Standard Error 1.160	-9.58 score on a scale Standard Error 1.168

Adverse Events

Placebo - Blinded Treatment

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Adalimumab 40mg - Blinded Treatment

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

IXE80Q2W - Blinded Treatment

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

IXE80Q4W - Blinded Treatment

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

ADA/PBO - Washout Treatment Period

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

PBO/IXE - Extended Treatment Period

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

ADA/PBO/IXE - Extended Treatment Period

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

IXE80Q2W/IXE80Q2W - Extended Treatment

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

IXE80Q4W/IXE80Q4W - Extended Treatment

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

PBO-follow-up Period

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

IXE80Q2W-follow-up Period

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

IXE80Q4W-follow-up Period

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Blinded Treatment n=86 participants at risk Participants received placebo every two weeks by subcutaneous injection.	Adalimumab 40mg - Blinded Treatment n=90 participants at risk Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q2W - Blinded Treatment n=83 participants at risk Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.	IXE80Q4W - Blinded Treatment n=81 participants at risk Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	ADA/PBO - Washout Treatment Period n=88 participants at risk Participants received placebo by subcutaneous injection	PBO/IXE - Extended Treatment Period n=86 participants at risk Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Q2W or 80mg Q4W by subcutaneous injection.	ADA/PBO/IXE - Extended Treatment Period n=86 participants at risk Participants received 80mg Ixekizumab Q2W or 80mg Q4W by subcutaneous injection.	IXE80Q2W/IXE80Q2W - Extended Treatment n=79 participants at risk Participants received 80mg Ixekizumab every two weeks by subcutaneous injection.	IXE80Q4W/IXE80Q4W - Extended Treatment n=78 participants at risk Participants received 80mg Ixekizumab every four weeks by subcutaneous injection.	PBO-follow-up Period n=1 participants at risk Participants did not receive any intervention.	IXE80Q2W-follow-up Period n=24 participants at risk Participants did not receive any intervention.	IXE80Q4W-follow-up Period n=16 participants at risk Participants did not receive any intervention.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Atrioventricular block complete	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/83 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/83 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Appendicitis	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Cellulitis	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 2 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/83 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 haemophilus	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Tonsillitis	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/79 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/81 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Ankle fracture	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Avulsion fracture	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/79 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Cervical vertebral fracture	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Post procedural haematoma	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Radius fracture	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/78 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Road traffic accident	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/78 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/78 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/78 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Plica syndrome	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/79 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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) Bladder cancer	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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) Parathyroid tumour benign	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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) Skin papilloma	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/79 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Cerebral haemorrhage	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Subarachnoid haemorrhage	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Nephrolithiasis	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Adnexal torsion	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/83 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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

Other adverse events
Measure	Placebo - Blinded Treatment n=86 participants at risk Participants received placebo every two weeks by subcutaneous injection.	Adalimumab 40mg - Blinded Treatment n=90 participants at risk Participants received 40mg Adalimumab every two weeks by SC injection.	IXE80Q2W - Blinded Treatment n=83 participants at risk Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.	IXE80Q4W - Blinded Treatment n=81 participants at risk Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.	ADA/PBO - Washout Treatment Period n=88 participants at risk Participants received placebo by subcutaneous injection	PBO/IXE - Extended Treatment Period n=86 participants at risk Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Q2W or 80mg Q4W by subcutaneous injection.	ADA/PBO/IXE - Extended Treatment Period n=86 participants at risk Participants received 80mg Ixekizumab Q2W or 80mg Q4W by subcutaneous injection.	IXE80Q2W/IXE80Q2W - Extended Treatment n=79 participants at risk Participants received 80mg Ixekizumab every two weeks by subcutaneous injection.	IXE80Q4W/IXE80Q4W - Extended Treatment n=78 participants at risk Participants received 80mg Ixekizumab every four weeks by subcutaneous injection.	PBO-follow-up Period n=1 participants at risk Participants did not receive any intervention.	IXE80Q2W-follow-up Period n=24 participants at risk Participants did not receive any intervention.	IXE80Q4W-follow-up Period n=16 participants at risk Participants did not receive any intervention.
Musculoskeletal and connective tissue disorders Back pain	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/83 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/79 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.8% 3/78 • Number of events 3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	12.5% 2/16 • Number of events 2 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Ocular discomfort	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/83 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/79 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/78 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	100.0% 1/1 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Diarrhoea	2.3% 2/86 • Number of events 2 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 2/83 • Number of events 2 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/86 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 1/86 • Number of events 4 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.1% 4/79 • Number of events 4 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.6% 2/78 • Number of events 2 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.2% 1/24 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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	2.3% 2/86 • Number of events 33 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.3% 3/90 • Number of events 6 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.4% 7/83 • Number of events 37 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/81 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/88 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.3% 8/86 • Number of events 53 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.3% 8/86 • Number of events 24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.6% 6/79 • Number of events 34 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.8% 3/78 • Number of events 4 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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	7.0% 6/86 • Number of events 6 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.7% 6/90 • Number of events 7 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.0% 5/83 • Number of events 6 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.4% 6/81 • Number of events 6 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.8% 6/88 • Number of events 6 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	19.8% 17/86 • Number of events 22 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.1% 7/86 • Number of events 8 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.9% 7/79 • Number of events 9 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.3% 8/78 • Number of events 8 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/24 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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	4.7% 4/86 • Number of events 5 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.8% 4/83 • Number of events 4 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.6% 7/81 • Number of events 8 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.3% 2/88 • Number of events 2 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.7% 4/86 • Number of events 4 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.7% 4/86 • Number of events 5 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.1% 8/79 • Number of events 9 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.1% 4/78 • Number of events 4 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.2% 1/24 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Vaginal infection	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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) Uterine leiomyoma	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Adnexal torsion	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Menopausal symptoms	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	100.0% 1/1 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. 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 Menstruation irregular	6.7% 1/15 • Number of events 1 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/13 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There 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 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Upto 76 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60