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Trial record 24 of 29 for:    LY2439821

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)

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ClinicalTrials.gov Identifier: NCT02513550
Recruitment Status : Completed
First Posted : July 31, 2015
Results First Posted : April 18, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Ixekizumab
Drug: Placebo
Enrollment 1257
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort 80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort
Hide Arm/Group Description 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Period Title: Double Blind Treatment Period
Started 310 306 611 9 5 16
Received at Least One Dose of Study Drug 310 306 609 9 5 16
Completed 274 268 537 9 4 15
Not Completed 36 38 74 0 1 1
Reason Not Completed
Withdrawal by Subject             11             11             25             0             0             0
Adverse Event             5             13             17             0             1             0
Lost to Follow-up             9             7             11             0             0             1
Lack of Efficacy             4             5             6             0             0             0
Protocol Violation             1             1             4             0             0             0
Physician Decision             2             0             4             0             0             0
Site terminated by sponsor             1             1             3             0             0             0
Met exclusion criteria and was not dosed             0             0             1             0             0             0
Due to personal business             2             0             1             0             0             0
Death             1             0             2             0             0             0
Period Title: Post-Treatment Follow-up Period
Started 285 [1] 283 [1] 559 [1] 9 [1] 4 [1] 15 [1]
Completed 254 244 496 9 4 15
Not Completed 31 39 63 0 0 0
Reason Not Completed
Withdrawal by Subject             12             20             26             0             0             0
Early terminated but completed follow-up             12             16             20             0             0             0
Lost to Follow-up             4             2             7             0             0             0
Adverse Event             1             1             4             0             0             0
Physician Decision             2             0             0             0             0             0
Death             0             0             1             0             0             0
Subject move out of town             0             0             1             0             0             0
Subject did not come for Visit-802             0             0             3             0             0             0
Labor Reasons             0             0             1             0             0             0
[1]
Participants who discontinued double blind phase had an option to enter post-treatment phase.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort 80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort Total
Hide Arm/Group Description 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind. Total of all reporting groups
Overall Number of Baseline Participants 310 306 611 9 5 16 1257
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 310 participants 306 participants 609 participants 9 participants 5 participants 16 participants 1255 participants
47.4  (13.50) 45.9  (12.85) 49.0  (13.61) 40.0  (9.62) 46.0  (13.17) 46.1  (13.05) 47.8  (13.45)
[1]
Measure Analysis Population Description: All randomized participants who received at least one dose of study drug and had baseline age data.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
Female 111 107 199 2 0 4 423
Male 199 199 412 7 5 12 834
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
Hispanic or Latino 59 55 111 0 0 0 225
Not Hispanic or Latino 243 244 489 9 5 16 1006
Unknown or Not Reported 8 7 11 0 0 0 26
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
American Indian or Alaska Native 11 12 23 0 0 0 46
Asian 31 32 64 9 5 16 157
Native Hawaiian or Other Pacific Islander 0 0 4 0 0 0 4
Black or African American 14 8 22 0 0 0 44
White 251 253 486 0 0 0 990
More than one race 3 1 12 0 0 0 16
Unknown or Not Reported 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Puerto Rico Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
14 16 29 0 0 0 59
Argentina Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
9 9 19 0 0 0 37
Romania Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
5 5 9 0 0 0 19
Hungary Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
11 10 23 0 0 0 44
United States Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
119 118 238 0 0 0 475
Czechia Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
3 3 8 0 0 0 14
Japan Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
5 2 9 0 0 0 16
Canada Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
49 49 99 0 0 0 197
South Korea Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
11 12 22 9 5 16 75
Taiwan Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
5 6 9 0 0 0 20
Poland Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
43 43 83 0 0 0 169
Mexico Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
10 8 17 0 0 0 35
Australia Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
14 14 28 0 0 0 56
Germany Number Analyzed 310 participants 306 participants 611 participants 9 participants 5 participants 16 participants 1257 participants
12 11 18 0 0 0 41
1.Primary Outcome
Title Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Hide Description The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of “0” or “1” with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 310 306 611
Measure Type: Number
Unit of Measure: Percentage of participants
70.6 72.5 78.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.005
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q4W/Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.522
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.9
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 310 306 611
Measure Type: Number
Unit of Measure: Percentage of participants
79 83.7 85.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q4W/Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.118
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving sPGA (0)
Hide Description The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of “0” or “1” with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 310 306 611
Measure Type: Number
Unit of Measure: Percentage of participants
44.8 48.7 60.1
4.Secondary Outcome
Title Percentage of Participants Achieving PASI 90
Hide Description PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 310 306 611
Measure Type: Number
Unit of Measure: Percentage of participants
65.2 73.9 79.5
5.Secondary Outcome
Title Percentage of Participants Achieving PASI 100
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 310 306 611
Measure Type: Number
Unit of Measure: Percentage of participants
43.5 49.3 59.7
6.Secondary Outcome
Title Change From Baseline in PASI
Hide Description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.

Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 274 268 538
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-18.34  (0.22) -18.95  (0.22) -19.41  (0.17)
7.Secondary Outcome
Title Percent Improvement in PASI
Hide Description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.

Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 274 268 538
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
91.09  (0.89) 94.24  (0.90) 96.25  (0.71)
8.Secondary Outcome
Title Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
Hide Description

The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.

LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned who had baseline and a post-baseline measurement for BSA affected by Psoriasis. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 274 268 538
Least Squares Mean (Standard Error)
Unit of Measure: Percent Body Surface Affected
-23.93  (0.34) -24.62  (0.34) -25.01  (0.27)
9.Secondary Outcome
Title Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Hide Description The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 52
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Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned who had baseline fingernail involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 156 148 314
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-19.27  (0.81) -19.87  (0.83) -20.82  (0.62)
10.Secondary Outcome
Title Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
Hide Description The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and had baseline scalp involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 252 245 477
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-18.35  (0.31) -18.73  (0.31) -18.65  (0.24)
11.Secondary Outcome
Title Mean Change From Baseline in Palmoplantar PASI (PPASI)
Hide Description The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and had baseline palmoplantar Ps involvement and had post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 72 82 150
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.55  (0.31) -9.37  (0.30) -9.00  (0.26)
12.Secondary Outcome
Title Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
Hide Description The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame Baseline, Week 52
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Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline Itch NRS score greater than or equal to (>=) 4. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 254 260 505
Measure Type: Number
Unit of Measure: Percentage of participants
74.0 72.3 77.2
13.Secondary Outcome
Title Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 310 306 611
Measure Type: Number
Unit of Measure: Percentage of participants
66.1 70.3 74.0
14.Secondary Outcome
Title Change From Baseline in DLQI Total Score
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline DLQI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind..
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 273 265 538
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.70  (0.21) -9.97  (0.22) -10.23  (0.17)
15.Secondary Outcome
Title Change From Baseline in Itch NRS Score
Hide Description The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline Itch NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 274 268 537
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.90  (0.13) -5.15  (0.13) -5.33  (0.10)
16.Secondary Outcome
Title Change From Baseline in Skin Pain Visual Analog Scale (VAS)
Hide Description The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline skin pain VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 271 262 532
Least Squares Mean (Standard Error)
Unit of Measure: mm
-35.50  (0.94) -36.77  (0.96) -38.07  (0.74)
17.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
Hide Description EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post baseline EQ-5D-5L VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 268 264 519
Least Squares Mean (Standard Error)
Unit of Measure: mm
11.93  (0.94) 12.47  (0.95) 14.42  (0.74)
18.Secondary Outcome
Title Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Hide Description Trough concentrations at steady state of Ixekizumab were evaluated.
Time Frame Predose, Week 4, 12, 24, 36 and 52 Post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed according to treatment to which they were assigned with evaluable PK samples that met the definition of being a trough concentration. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W Continuous 80 mg Ixekizumab Q4W/Q2W No Step 80 mg Ixekizumab Q4W/Q2W Step up 80 mg Ixekizumab Q2W Continuous
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 304 232 73 602
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram per milliliter (µg/mL)
Week 4
3.55
(76%)
4.03
(72%)
2.78
(67%)
7.87
(63%)
Week 12
2.72
(72%)
2.81
(80%)
1.95
(70%)
8.23
(56%)
Week 24
2.65
(73%)
2.71
(85%)
3.48
(78%)
7.89
(66%)
Week 36
2.83
(74%)
2.88
(73%)
5.76
(67%)
7.73
(76%)
Week 52
2.43
(79%)
2.77
(73%)
5.73
(68%)
6.96
(87%)
19.Secondary Outcome
Title Number of Participants With Anti-Ixekizumab Antibodies
Hide Description Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
Time Frame Baseline through Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of Ixekizumab and had evaluable anti-ixekizumab antibody measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Arm/Group Title 80 mg Ixekizumab Q4W 80 mg Ixekizumab Q4W/Q2W 80 mg Ixekizumab Q2W
Hide Arm/Group Description:
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Overall Number of Participants Analyzed 307 305 606
Measure Type: Number
Unit of Measure: participants
71 64 84
Time Frame Up to 19 months
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
 
Arm/Group Title Ixekizumab 80 mg Q4W - Treatment Period 80 mg Ixekizumab Q4W/Q2W - Treatment Period 80 mg Ixekizumab Q2W - Treatment Period 80 mg Ixekizumab Q4W - Post-Treatment Period 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period 80 mg Ixekizumab Q2W - Post-Treatment Period 80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
Hide Arm/Group Description 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind. Participants didn't receive any intervention. Participants didn't receive any intervention. Participants didn't receive any intervention. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind. Participants didn't receive any intervention. Participants didn't receive any intervention. Participants didn't receive any intervention.
All-Cause Mortality
Ixekizumab 80 mg Q4W - Treatment Period 80 mg Ixekizumab Q4W/Q2W - Treatment Period 80 mg Ixekizumab Q2W - Treatment Period 80 mg Ixekizumab Q4W - Post-Treatment Period 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period 80 mg Ixekizumab Q2W - Post-Treatment Period 80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/310 (0.00%)      0/306 (0.00%)      0/609 (0.00%)      0/285 (0.00%)      0/283 (0.00%)      0/559 (0.00%)      0/9 (0.00%)      0/5 (0.00%)      0/16 (0.00%)      0/9 (0.00%)      0/4 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ixekizumab 80 mg Q4W - Treatment Period 80 mg Ixekizumab Q4W/Q2W - Treatment Period 80 mg Ixekizumab Q2W - Treatment Period 80 mg Ixekizumab Q4W - Post-Treatment Period 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period 80 mg Ixekizumab Q2W - Post-Treatment Period 80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/310 (5.16%)      16/306 (5.23%)      32/609 (5.25%)      1/285 (0.35%)      2/283 (0.71%)      7/559 (1.25%)      0/9 (0.00%)      1/5 (20.00%)      0/16 (0.00%)      0/9 (0.00%)      0/4 (0.00%)      0/15 (0.00%)    
Cardiac disorders                         
Acute myocardial infarction  1  1/310 (0.32%)  1 0/306 (0.00%)  0 1/609 (0.16%)  3 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Atrial fibrillation  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Cardiac failure  1  0/310 (0.00%)  0 0/306 (0.00%)  0 2/609 (0.33%)  2 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Coronary artery disease  1  0/310 (0.00%)  0 1/306 (0.33%)  2 2/609 (0.33%)  2 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Myocardial infarction  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Pericarditis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Ear and labyrinth disorders                         
Vertigo  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Endocrine disorders                         
Goitre  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Eye disorders                         
Retinal detachment  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders                         
Colitis ulcerative  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Crohn's disease  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gastroenteritis eosinophilic  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  2 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal haemorrhage  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Intra-abdominal haematoma  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Oesophageal rupture  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Pancreatitis  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Umbilical hernia  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
General disorders                         
Chest discomfort  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Non-cardiac chest pain  1  1/310 (0.32%)  1 0/306 (0.00%)  0 2/609 (0.33%)  2 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Vascular stent restenosis  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Hepatobiliary disorders                         
Cholecystitis acute  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Cholecystitis chronic  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Cholelithiasis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Immune system disorders                         
Drug hypersensitivity  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations                         
Abscess limb  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Abscess oral  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Appendicitis  1  0/310 (0.00%)  0 1/306 (0.33%)  1 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Carbuncle  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Cellulitis  1  2/310 (0.65%)  2 2/306 (0.65%)  2 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Chronic sinusitis  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Chronic tonsillitis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gastroenteritis shigella  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Pneumonia  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Pyelonephritis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Pyelonephritis acute  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Sepsis  1  1/310 (0.32%)  1 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Urosepsis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Injury, poisoning and procedural complications                         
Clavicle fracture  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Fall  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Femur fracture  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Hand fracture  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Injury  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Joint dislocation  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Lower limb fracture  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Pelvic fracture  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Rib fracture  1  0/310 (0.00%)  0 2/306 (0.65%)  2 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Road traffic accident  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Wound dehiscence  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Investigations                         
International normalised ratio increased  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Metabolism and nutrition disorders                         
Diabetic ketoacidosis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gout  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Hypokalaemia  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Lactic acidosis  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Cartilage hypertrophy  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Intervertebral disc compression  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal chest pain  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  2 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
Adenocarcinoma  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Adenocarcinoma gastric  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Adenocarcinoma of colon  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Benign bone neoplasm  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 1/5 (20.00%)  1 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Breast cancer metastatic  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 1/283 (0.35%)  1 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Colon cancer  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Dermatofibrosarcoma protuberans  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Invasive breast carcinoma  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Invasive ductal breast carcinoma  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Neurilemmoma benign  1  0/310 (0.00%)  0 1/306 (0.33%)  1 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Plasma cell myeloma  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 1/285 (0.35%)  1 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders                         
Basilar migraine  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Cerebrovascular accident  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 1/283 (0.35%)  1 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Hyposmia  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Transient ischaemic attack  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                         
Ectopic pregnancy  1  0/111 (0.00%)  0 0/107 (0.00%)  0 0/199 (0.00%)  0 0/98 (0.00%)  0 0/98 (0.00%)  0 1/184 (0.54%)  1 0/2 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/4 (0.00%)  0
Tubal rupture  1  0/111 (0.00%)  0 0/107 (0.00%)  0 0/199 (0.00%)  0 0/98 (0.00%)  0 0/98 (0.00%)  0 1/184 (0.54%)  1 0/2 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/4 (0.00%)  0
Psychiatric disorders                         
Anxiety  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Depression  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Major depression  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Stress  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Suicide attempt  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders                         
Renal haematoma  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Urinary retention  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Reproductive system and breast disorders                         
Benign prostatic hyperplasia  1  1/199 (0.50%)  1 0/199 (0.00%)  0 0/410 (0.00%)  0 0/187 (0.00%)  0 0/185 (0.00%)  0 0/375 (0.00%)  0 0/7 (0.00%)  0 0/5 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Pulmonary microemboli  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders                         
Dermatitis contact  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Psoriasis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Rash macular  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Stevens-johnson syndrome  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Vascular disorders                         
Deep vein thrombosis  1  0/310 (0.00%)  0 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixekizumab 80 mg Q4W - Treatment Period 80 mg Ixekizumab Q4W/Q2W - Treatment Period 80 mg Ixekizumab Q2W - Treatment Period 80 mg Ixekizumab Q4W - Post-Treatment Period 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period 80 mg Ixekizumab Q2W - Post-Treatment Period 80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort 80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   157/310 (50.65%)      136/306 (44.44%)      285/609 (46.80%)      16/285 (5.61%)      20/283 (7.07%)      40/559 (7.16%)      6/9 (66.67%)      4/5 (80.00%)      11/16 (68.75%)      2/9 (22.22%)      0/4 (0.00%)      2/15 (13.33%)    
Blood and lymphatic system disorders                         
Neutropenia  1  2/310 (0.65%)  2 0/306 (0.00%)  0 1/609 (0.16%)  2 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Eye disorders                         
Retinal vein occlusion  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  2 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders                         
Dry mouth  1  0/310 (0.00%)  0 2/306 (0.65%)  2 2/609 (0.33%)  2 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Dyspepsia  1  2/310 (0.65%)  2 1/306 (0.33%)  1 4/609 (0.66%)  4 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 1/9 (11.11%)  1 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gastric ulcer  1  1/310 (0.32%)  1 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Gastritis  1  3/310 (0.97%)  3 1/306 (0.33%)  1 4/609 (0.66%)  4 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Mouth ulceration  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
General disorders                         
Injection site erythema  1  4/310 (1.29%)  14 3/306 (0.98%)  4 18/609 (2.96%)  49 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 2/16 (12.50%)  24 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Injection site oedema  1  1/310 (0.32%)  4 0/306 (0.00%)  0 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 2/16 (12.50%)  24 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Injection site pain  1  4/310 (1.29%)  4 6/306 (1.96%)  7 8/609 (1.31%)  26 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Injection site pruritus  1  1/310 (0.32%)  4 0/306 (0.00%)  0 4/609 (0.66%)  13 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Injection site reaction  1  18/310 (5.81%)  68 5/306 (1.63%)  15 49/609 (8.05%)  256 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Injection site swelling  1  2/310 (0.65%)  11 0/306 (0.00%)  0 7/609 (1.15%)  11 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Xerosis  1  1/310 (0.32%)  1 2/306 (0.65%)  2 1/609 (0.16%)  1 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations                         
Furuncle  1  3/310 (0.97%)  3 1/306 (0.33%)  1 5/609 (0.82%)  5 1/285 (0.35%)  1 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Hordeolum  1  4/310 (1.29%)  7 2/306 (0.65%)  2 4/609 (0.66%)  4 0/285 (0.00%)  0 1/283 (0.35%)  1 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0
Influenza  1  6/310 (1.94%)  6 9/306 (2.94%)  10 5/609 (0.82%)  5 1/285 (0.35%)  1 2/283 (0.71%)  2 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Mumps  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 1/5 (20.00%)  1 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Otitis externa  1  3/310 (0.97%)  4 3/306 (0.98%)  4 8/609 (1.31%)  8 0/285 (0.00%)  0 1/283 (0.35%)  1 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Tinea pedis  1  6/310 (1.94%)  6 4/306 (1.31%)  4 8/609 (1.31%)  10 0/285 (0.00%)  0 0/283 (0.00%)  0 1/559 (0.18%)  1 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Tonsillitis  1  1/310 (0.32%)  2 2/306 (0.65%)  2 6/609 (0.99%)  6 0/285 (0.00%)  0 0/283 (0.00%)  0 2/559 (0.36%)  2 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Upper respiratory tract infection  1  46/310 (14.84%)  60 39/306 (12.75%)  56 69/609 (11.33%)  93 1/285 (0.35%)  1 3/283 (1.06%)  3 3/559 (0.54%)  3 2/9 (22.22%)  2 1/5 (20.00%)  1 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Urinary tract infection  1  16/310 (5.16%)  21 4/306 (1.31%)  4 15/609 (2.46%)  20 0/285 (0.00%)  0 2/283 (0.71%)  2 6/559 (1.07%)  6 0/9 (0.00%)  0 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Vaginal infection  1  0/111 (0.00%)  0 1/107 (0.93%)  1 0/199 (0.00%)  0 0/98 (0.00%)  0 0/98 (0.00%)  0 0/184 (0.00%)  0 0/2 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/2 (0.00%)  0 0/0  0 0/4 (0.00%)  0
Viral upper respiratory tract infection  1  41/310 (13.23%)  49 53/306 (17.32%)  69 73/609 (11.99%)  89 6/285 (2.11%)  7 0/283 (0.00%)  0 9/559 (1.61%)  9 1/9 (11.11%)  1 1/5 (20.00%)  1 6/16 (37.50%)  9 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Investigations                         
Alanine aminotransferase increased  1  7/310 (2.26%)  7 2/306 (0.65%)  2 3/609 (0.49%)  3 0/285 (0.00%)  0 1/283 (0.35%)  1 0/559 (0.00%)  0 1/9 (11.11%)  1 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Aspartate aminotransferase increased  1  5/310 (1.61%)  5 2/306 (0.65%)  2 3/609 (0.49%)  3 0/285 (0.00%)  0 1/283 (0.35%)  1 0/559 (0.00%)  0 1/9 (11.11%)  1 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Blood glucose increased  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 1/283 (0.35%)  1 0/559 (0.00%)  0 0/9 (0.00%)  0 1/5 (20.00%)  1 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Helicobacter test positive  1  0/310 (0.00%)  0 0/306 (0.00%)  0 0/609 (0.00%)  0 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Arthralgia  1  7/310 (2.26%)  8 5/306 (1.63%)  5 25/609 (4.11%)  29 2/285 (0.70%)  3 1/283 (0.35%)  1 4/559 (0.72%)  4 0/9 (0.00%)  0 1/5 (20.00%)  1 1/16 (6.25%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Myalgia  1  2/310 (0.65%)  2 0/306 (0.00%)  0 6/609 (0.99%)  6 0/285 (0.00%)  0 0/283 (0.00%)  0 0/559 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 2/16 (12.50%)  2 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Osteoarthritis  1  4/310 (1.29%)  4 2/306 (0.65%)  2 4/609 (0.66%)  4 0/285 (0.00%)  0 1/283 (0.35%)  1 0/559 (0.00%)  0 1/9 (11.11%)  1 0/5 (0.00%)  0 0/16 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0
Periarthritis  1