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Trial record 16 of 29 for:    LY2439821

A Study in Participants With Moderate to Severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01107457
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Biological: Ixekizumab
Drug: Placebo
Enrollment 142
Recruitment Details This study has 3 parts:Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging design (approximately 20-40 weeks [wks]).Treatment durability (sustained efficacy off treatment) from Week 20 up to Week 32 was evaluated during Part A.
Pre-assignment Details Part B is an optional extension period with an open-label design (approximately 240 weeks). Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks).
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab 120 mg/80 mg Total Ixekizumab
Hide Arm/Group Description

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 milligrams (mg) ixekizumab given subcutaneous (SC) every 4 weeks (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

Administered 80 mg ixekizumab SC Q4W through week 344.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Period Title: Part A
Started 27 28 30 29 28 0 [1]
Received at Least 1 Dose of Study Drug 27 28 30 29 28 0 [1]
Completed 22 21 29 26 27 0 [1]
Not Completed 5 7 1 3 1 0
Reason Not Completed
Adverse Event             1             2             1             0             0             0
Withdrawal by Subject             3             3             0             3             1             0
Lost to Follow-up             0             1             0             0             0             0
Lack of Efficacy             1             0             0             0             0             0
Protocol Violation             0             1             0             0             0             0
[1]
120 mg and 80 mg ixekizumab were administered during Part B and C.
Period Title: Part B and C
Started 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 120 [2]
Completed Part B (Week 240) 0 0 0 0 0 74
Completed Part C 0 0 0 0 0 0 [3]
Post Treatment Safety Visits 0 0 0 0 0 6 [4]
Completed 0 0 0 0 0 0 [5]
Not Completed 0 0 0 0 0 120
Reason Not Completed
Adverse Event             0             0             0             0             0             12
Inclusion/Exclusion Criteria Not Met             0             0             0             0             0             1
Physician Decision             0             0             0             0             0             3
Lack of Efficacy             0             0             0             0             0             7
Lost to Follow-up             0             0             0             0             0             10
Protocol Violation             0             0             0             0             0             1
Sponsor Decision             0             0             0             0             0             66
Withdrawal by Subject             0             0             0             0             0             16
Clinical Relapse             0             0             0             0             0             4
[1]
Placebo,10mg, 25mg,75mg and 150mg ixekizumab were administered during in Part A.
[2]
80 and 120 mg ixekizumab were administered during Part B and C.
[3]
Part C was stopped once ixekizumab became available through marketing authorization.
[4]
Only participants with neutropenia entered the post treatment safety visits.
[5]
No participants completed the study as Part C was stopped.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab Total
Hide Arm/Group Description

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

80 mg ixekizumab given SC Q4W through week 344.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part B: (optional)

Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Part C: (optional)

Administered 80 mg ixekizumab SC Q4W through week 344.

Total of all reporting groups
Overall Number of Baseline Participants 27 28 30 29 28 142
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 30 participants 29 participants 28 participants 142 participants
45  (12.76) 47.65  (11.20) 45.93  (14.53) 46.37  (12.50) 45.97  (13.00) 46.19  (12.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 30 participants 29 participants 28 participants 142 participants
Female 13 12 12 10 14 61
Male 14 16 18 19 14 81
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 30 participants 29 participants 28 participants 142 participants
Hispanic or Latino 5 5 7 4 4 25
Not Hispanic or Latino 22 23 23 25 24 117
Unknown or Not Reported 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 30 participants 29 participants 28 participants 142 participants
American Indian or Alaska Native 0 0 1 1 0 2
Asian 0 1 0 2 1 4
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0
Black or African American 2 0 1 2 2 7
White 25 27 28 24 25 129
More than one race 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 30 participants 29 participants 28 participants 142 participants
United States 27 27 29 28 28 139
Denmark 0 1 1 1 0 3
Baseline in Psoriasis Area and Severity Index (PASI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 28 participants 30 participants 29 participants 28 participants 142 participants
16.45  (5.26) 19.18  (7.96) 18.55  (4.94) 17.20  (4.26) 17.70  (6.21) 17.83  (5.85)
[1]
Measure Description: PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). 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 (none) to 4 (very severe). 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 psoriasis) to 72(the most severe disease).
1.Primary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Hide Description PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). 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 (none) to 4 (very severe). 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 psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 26 28 30 29 28
Measure Type: Number
Unit of Measure: percentage of participants
7.7 28.6 76.7 82.8 82.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 25 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 150 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Percentage of PASI Improvement From Baseline to 12 Week Endpoint
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). 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 (none) to 4 (very severe). Each area is scored by itself and the scores were 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 psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline PASI assessment.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 23 27 29 29 26
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of improvement in PASI score
16.22
(4.44 to 28.01)
49.33
(38.25 to 60.41)
78.48
(67.67 to 89.29)
85.69
(74.87 to 96.50)
87.12
(75.94 to 98.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 25 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 150 mg Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12
Hide Description The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 26 28 30 29 28
Measure Type: Number
Unit of Measure: percentage of participants
7.7 25.0 70.0 72.4 71.4
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks
Hide Description Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Time Frame Baseline Up to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 27 28 30 29 28
Measure Type: Number
Unit of Measure: Participants
17 21 21 17 13
5.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16
Hide Description The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.
Time Frame Baseline, Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 25 28 29 29 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Anxiety -0.86  (0.58) -1.97  (0.55) -2.10  (0.54) -2.17  (0.54) -2.81  (0.55)
Depression 0.17  (0.54) -1.86  (0.51) -1.75  (0.51) -2.52  (0.51) -2.01  (0.51)
6.Secondary Outcome
Title Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16
Hide Description The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame Baseline, Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 24 27 26 27 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.49  (0.56) -1.56  (0.52) -1.48  (0.53) -2.13  (0.52) -2.21  (0.54)
7.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PatGA) at Week 12
Hide Description The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame Baseline, 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 26 28 30 29 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.6  (0.3) -1.1  (0.3) -2.3  (0.2) -2.9  (0.3) -2.5  (0.3)
8.Secondary Outcome
Title Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12
Hide Description The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with self-reported psoriatic arthritis at baseline were included in the analysis. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 4 7 11 8 8
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeter (mm)
3.87
(-20.90 to 28.64)
-4.32
(-23.05 to 14.41)
-19.36
(-34.31 to -4.40)
-21.24
(-37.89 to -4.58)
-34.24
(-51.83 to -16.66)
9.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16
Hide Description MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame Baseline, Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 25 28 29 29 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sleep Problems Index I -0.05  (2.61) -5.35  (2.46) -8.78  (2.42) -7.97  (2.42) -2.38  (2.47)
Sleep Problems Index II 0.21  (2.37) -6.42  (2.24) -9.23  (2.20) -8.43  (2.20) -2.48  (2.24)
Sleep Adequacy -2.83  (4.73) 5.63  (4.47) 11.35  (4.39) 8.81  (4.39) -0.41  (4.48)
Sleep Disturbance -1.47  (3.27) -8.56  (3.10) -10.02  (3.03) -11.50  (3.04) -4.67  (3.09)
Sleep Somnolence 1.12  (2.73) -2.32  (2.58) -7.14  (2.53) -5.80  (2.53) -0.76  (2.58)
Snoring -2.85  (4.22) -0.47  (3.94) 2.94  (3.88) -3.24  (3.87) -3.81  (3.94)
Sleep Short of Breath/headache 4.34  (3.10) -5.45  (2.92) -2.84  (2.87) -2.65  (2.87) -3.46  (2.91)
10.Secondary Outcome
Title Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))
Hide Description The PMRU is a 3‑item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 26 28 30 29 28
Measure Type: Number
Unit of Measure: participants
Week 16 - Office or Clinic(n=23,24,29,28,27) 1 0 0 1 3
Week 16 - Emergency Room(ER)(n=23, 24, 29, 28, 27) 0 0 0 0 1
Week 16 - Admitted thru ER (n=26,28,30,29,28) 0 0 0 0 0
Week 16 - Hospital Stay (n=26,28,30,29,28) 0 0 0 0 0
11.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16
Hide Description The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) *100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]) * 100 and Activity Impairment = (Q6/10) * 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame Baseline, Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 26 28 30 29 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Absenteeism (n=15,19,14,19,16) -1.91  (1.88) 0.71  (1.68) -0.83  (1.94) -2.64  (1.67) -1.96  (1.82)
Presenteeism (n=15,20,16,19,16) -3.38  (3.99) -0.99  (3.47) -4.59  (3.87) -14.48  (3.55) -10.69  (3.90)
Work productivity loss (n=15,19,14,19,16) -3.65  (4.30) 1.74  (3.82) -4.65  (4.45) -14.76  (3.82) -11.12  (4.17)
Activity Impairment (n=25,28,28,29,27) -0.68  (4.19) -9.76  (3.96) -14.96  (3.95) -12.81  (3.90) -14.79  (4.03)
12.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16
Hide Description The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame Baseline, Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 25 28 28 29 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
PCS -1.22  (2.15) 2.41  (2.03) 1.95  (2.03) 3.94  (2.00) 5.72  (2.03)
MCS -0.56  (2.29) 7.27  (2.19) 5.16  (2.18) 4.13  (2.13) 4.15  (2.16)
13.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12
Hide Description The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline nail involvement were included in the analysis.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 14 13 10 10 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.21
(-5.17 to 9.58)
-4.85
(-12.82 to 3.12)
-3.65
(-12.73 to 5.43)
-15.89
(-24.98 to -6.81)
-19.91
(-29.00 to -10.83)
14.Secondary Outcome
Title Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12
Hide Description The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with palmoplantar involvement were included in the analysis.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 1 4 4 2 2
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.0
(-10.3 to 8.3)
-6.4
(-12.3 to -0.5)
-4.6
(-10.3 to 1.2)
-3.4
(-11.5 to 4.8)
-12.8
(-20.9 to -4.7)
15.Secondary Outcome
Title Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12
Hide Description The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline scalp involvement were included in the analysis.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 17 21 24 18 22
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-7.3
(-11.2 to -3.5)
-10.2
(-13.9 to -6.6)
-15.8
(-19.2 to -12.4)
-15.0
(-18.9 to -11.0)
-17.2
(-20.8 to -13.7)
16.Secondary Outcome
Title Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)
Hide Description The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.
Time Frame Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title All Participants (10mg, 25mg,75mg & 150 mg Ixekizumab)
Hide Arm/Group Description:

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 115
Mean (95% Confidence Interval)
Unit of Measure: liters per hour (L/hr)
0.0177
(0.0160 to 0.0199)
17.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16
Hide Description The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.
Time Frame Baseline, Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 25 28 29 29 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.24  (0.97) -6.35  (0.92) -6.59  (0.90) -8.39  (0.90) -8.17  (0.92)
18.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Hide Description PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).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(none) to 4(very severe).Each area is scored by itself and the scores were 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 psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 26 28 30 29 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.50  (1.21) 8.20  (1.17) 13.56  (1.12) 14.99  (1.14) 15.38  (1.16)
19.Secondary Outcome
Title Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)
Hide Description PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). 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 (none) to 4 (very severe). 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 psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Time Frame Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 6 22 23 23 23
Measure Type: Number
Unit of Measure: percentage of participants
0 50.0 59.1 56.5 82.6
20.Secondary Outcome
Title Percentage of PASI Improvement From Baseline Through 32 Weeks
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). 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 (none) to 4 (very severe). Each area is scored by itself and the scores were 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 psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.
Time Frame Baseline Through 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Zero participants in the placebo arm had data.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 0 4 16 18 21
Mean (Standard Deviation)
Unit of Measure: Percentage PASI improvement
80.55  (17.69) 85.60  (12.74) 85.16  (15.30) 88.11  (11.35)
21.Secondary Outcome
Title Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement
Hide Description The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.
Time Frame Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. Zero participants in the placebo arm had data.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 0 6 22 23 23
Measure Type: Number
Unit of Measure: percentage of participants
33.3 45.5 47.8 65.2
22.Secondary Outcome
Title Percentage of Participants With Anti-Ixekizumab Antibodies
Hide Description Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Time Frame Baseline through Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline antibody assessment.
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab
Hide Arm/Group Description:

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Overall Number of Participants Analyzed 25 24 30 29 27
Measure Type: Number
Unit of Measure: percentage of participants
4.0 54.2 40.0 17.2 22.2
23.Secondary Outcome
Title Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)
Hide Description The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.
Time Frame Baseline Up to 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had PASI 75 response at Week 20.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC.

Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: percentage of participants
78.4
24.Secondary Outcome
Title Number of Treatment Emergent Adverse Events up to 344 Weeks
Hide Description Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Time Frame Baseline Up to 344 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
105
25.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Hide Description The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.
Time Frame Baseline Up to 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had PASI 75 response at Week 20.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Anxiety -3.0  (3.4)
Depression -2.8  (3.0)
26.Secondary Outcome
Title Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)
Hide Description The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).
Time Frame Week 240
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had PASI 75 response at Week 20.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
0(Clear) 40
1 26
2 4
3 2
4 2
5(Severe) 0
27.Secondary Outcome
Title Change From Baseline in Pain Visual Analog Scale (VAS)
Hide Description The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used.
Time Frame Baseline Up to 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with data available.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 24
Mean (Standard Error)
Unit of Measure: Millimeters (mm)
-13.25  (32.34)
28.Secondary Outcome
Title Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis
Hide Description

The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing.

Baseline is defined as the last available value prior to the first dose in Part A of the study.

Time Frame Baseline Up to 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with baseline nail psoriasis.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
-33.62  (30.48)
29.Secondary Outcome
Title Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis
Hide Description

The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.

Baseline is defined as the last available value prior to the first dose in Part A of the study.

Time Frame Baseline Up to 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with baseline scalp psoriasis.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-19.89  (13.68)
30.Secondary Outcome
Title Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis
Hide Description The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.
Time Frame Baseline Up to 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with baseline palmoplantar psoriasis.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.10  (7.59)
31.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Hide Description PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). 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 (none) to 4 (very severe). 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 psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Time Frame Week 240
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had PASI 75 response at Week 20.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: percentage of participants
97.3
32.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI)
Hide Description

The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant.

Baseline is defined as the last available value prior to the first dose in Part A of the study.

Time Frame Baseline Up to 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had PASI 75 response at Week 20.
Arm/Group Title Total Ixekizumab (80 mg and 120 mg)
Hide Arm/Group Description:

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

During Part B of the study, participants were initially assigned to ixekizumab (LY2439821) 120 mg SC and were transitioned to ixekizumab 80 mg SC

Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.2  (5.6)
Time Frame [Not Specified]
Adverse Event Reporting Description Treatment durability refers to participants who had a PASI 75 response at Week 20 and remained in Part A of the study from Week 20-32 (treatment-free period). These participants moved to Part B of the study upon completion of Part A through Week 32 or upon loss of PASI75 response during the Part A treatment-free period.
 
Arm/Group Title Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab Treatment Durability 120 mg and 80 mg Total Ixekizumab Post Treatment Safety Visits
Hide Arm/Group Description

Part A:

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A:

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Part A: Treatment durability/safety follow-up period:12 to 20 weeks.

Part B: (optional)

120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Participants who were followed due to neutropenia.
All-Cause Mortality
Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab Treatment Durability 120 mg and 80 mg Total Ixekizumab Post Treatment Safety Visits
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   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab Treatment Durability 120 mg and 80 mg Total Ixekizumab Post Treatment Safety Visits
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   1/27 (3.70%)      1/28 (3.57%)      1/30 (3.33%)      0/29 (0.00%)      0/28 (0.00%)      1/74 (1.35%)      24/120 (20.00%)      0/6 (0.00%)    
Cardiac disorders                 
Acute coronary syndrome  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Arteriosclerosis coronary artery  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Atrial fibrillation  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Cardiac failure congestive  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Mitral valve prolapse  1  0/27 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Gastrointestinal disorders                 
Pancreatitis acute  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Infections and infestations                 
Abdominal abscess  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  2 0/6 (0.00%)  0
Cellulitis  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  2 0/6 (0.00%)  0
Incision site infection  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Influenza  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Pyelonephritis  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Soft tissue infection  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Wound infection  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications                 
Fall  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Fibula fracture  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Laceration  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Tibia fracture  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Wrist fracture  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Metabolism and nutrition disorders                 
Diabetes mellitus inadequate control  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Cervical spinal stenosis  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  2 0/6 (0.00%)  0
Intervertebral disc protrusion  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  2 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Invasive ductal breast carcinoma  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Non-small cell lung cancer metastatic  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Rectal adenocarcinoma  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Rectal adenoma  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Uterine leiomyoma  1  0/13 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/10 (0.00%)  0 0/14 (0.00%)  0 0/33 (0.00%)  0 1/50 (2.00%)  1 0/4 (0.00%)  0
Nervous system disorders                 
Cerebrovascular accident  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                 
Abortion missed  1  0/13 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/10 (0.00%)  0 0/14 (0.00%)  0 0/33 (0.00%)  0 1/50 (2.00%)  1 0/4 (0.00%)  0
Psychiatric disorders                 
Depression  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  2 0/6 (0.00%)  0
Suicide attempt  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Renal and urinary disorders                 
Nephrolithiasis  1  0/27 (0.00%)  0 0/28 (0.00%)  0 1/30 (3.33%)  1 0/29 (0.00%)  0 0/28 (0.00%)  0 1/74 (1.35%)  1 2/120 (1.67%)  3 0/6 (0.00%)  0
Urinary tract obstruction  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Reproductive system and breast disorders                 
Breast cyst  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Dysmenorrhoea  1  1/13 (7.69%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/10 (0.00%)  0 0/14 (0.00%)  0 0/33 (0.00%)  0 0/50 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Dyspnoea  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Laryngeal oedema  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Hidradenitis  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  2 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 10 mg Ixekizumab 25 mg Ixekizumab 75 mg Ixekizumab 150 mg Ixekizumab Treatment Durability 120 mg and 80 mg Total Ixekizumab Post Treatment Safety Visits
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   13/27 (48.15%)      15/28 (53.57%)      12/30 (40.00%)      10/29 (34.48%)      11/28 (39.29%)      11/74 (14.86%)      82/120 (68.33%)      1/6 (16.67%)    
Gastrointestinal disorders                 
Diarrhoea  1  0/27 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0 1/29 (3.45%)  1 1/28 (3.57%)  1 0/74 (0.00%)  0 9/120 (7.50%)  13 0/6 (0.00%)  0
Nausea  1  1/27 (3.70%)  1 1/28 (3.57%)  1 0/30 (0.00%)  0 2/29 (6.90%)  2 0/28 (0.00%)  0 0/74 (0.00%)  0 5/120 (4.17%)  7 0/6 (0.00%)  0
General disorders                 
Injection site reaction  1  0/27 (0.00%)  0 0/28 (0.00%)  0 3/30 (10.00%)  4 1/29 (3.45%)  1 2/28 (7.14%)  3 0/74 (0.00%)  0 4/120 (3.33%)  17 0/6 (0.00%)  0
Peripheral swelling  1  2/27 (7.41%)  3 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/6 (0.00%)  0
Immune system disorders                 
Hypersensitivity  1  1/27 (3.70%)  1 1/28 (3.57%)  1 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 1/6 (16.67%)  2
Infections and infestations                 
Bronchitis  1  0/27 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 10/120 (8.33%)  16 0/6 (0.00%)  0
Ear infection  1  0/27 (0.00%)  0 2/28 (7.14%)  2 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 6/120 (5.00%)  6 0/6 (0.00%)  0
Influenza  1  0/27 (0.00%)  0 0/28 (0.00%)  0 1/30 (3.33%)  1 0/29 (0.00%)  0 1/28 (3.57%)  1 1/74 (1.35%)  1 9/120 (7.50%)  10 0/6 (0.00%)  0
Nasopharyngitis  1  5/27 (18.52%)  5 3/28 (10.71%)  3 3/30 (10.00%)  3 3/29 (10.34%)  3 4/28 (14.29%)  4 2/74 (2.70%)  2 29/120 (24.17%)  57 0/6 (0.00%)  0
Sinusitis  1  1/27 (3.70%)  1 0/28 (0.00%)  0 0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0 1/74 (1.35%)  1 17/120 (14.17%)  24 0/6 (0.00%)  0
Tooth infection  1  0/27 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0 0/74 (0.00%)  0 11/120 (9.17%)  12 0/6 (0.00%)  0
Upper respiratory tract infection  1  1/27 (3.70%)  1 1/28 (3.57%)  1 3/30 (10.00%)  3 1/29 (3.45%)  1 1/28 (3.57%)  1 0/74 (0.00%)  0 15/120 (12.50%)  21 0/6 (0.00%)  0
Urinary tract infection  1  0/27 (0.00%)  0 1/28 (3.57%)  1 1/30 (3.33%)  1 0/29 (0.00%)  0 1/28 (3.57%)  1 2/74 (2.70%)  2 13/120 (10.83%)  23 0/6 (0.00%)  0
Injury, poisoning and procedural complications                 
Laceration  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 2/29 (6.90%)  2 1/28 (3.57%)  1 1/74 (1.35%)  1 3/120 (2.50%)  3 0/6 (0.00%)  0
Muscle strain  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 1/29 (3.45%)  1 0/28 (0.00%)  0 0/74 (0.00%)  0 8/120 (6.67%)  11 0/6 (0.00%)  0
Metabolism and nutrition disorders                 
Hypertriglyceridaemia  1  2/27 (7.41%)  2 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 3/120 (2.50%)  3 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Arthralgia  1  1/27 (3.70%)  1 0/28 (0.00%)  0 1/30 (3.33%)  1 1/29 (3.45%)  1 0/28 (0.00%)  0 1/74 (1.35%)  1 7/120 (5.83%)  7 0/6 (0.00%)  0
Back pain  1  0/27 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 8/120 (6.67%)  8 0/6 (0.00%)  0
Psoriatic arthropathy  1  2/27 (7.41%)  2 0/28 (0.00%)  0 0/30 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/74 (0.00%)  0 6/120 (5.00%)  6 0/6 (0.00%)  0
Nervous system disorders                 
Dizziness  1  0/27 (0.00%)  0 2/28 (7.14%)  2 0/30 (0.00%)  0 2/29 (6.90%)  2 0/28 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/6 (0.00%)  0
Headache  1  1/27 (3.70%)  1 4/28 (14.29%)  7 4/30 (13.33%)  11 1/29 (3.45%)  1 1/28 (3.57%)  1 3/74 (4.05%)  3 12/120 (10.00%)  20 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Cough  1  0/27 (0.00%)  0 1/28 (3.57%)  1 0/30 (0.00%)  0 2/29 (6.90%)  2 0/28 (0.00%)  0 0/74 (0.00%)  0 5/120 (4.17%)  5 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Dermatitis contact  1  0/27 (0.00%)  0 0/28 (0.00%)  0 1/30 (3.33%)  1 0/29 (0.00%)  0 2/28 (7.14%)  2 0/74 (0.00%)  0 8/120 (6.67%)  15 0/6 (0.00%)  0
Dry skin  1  0/27 (0.00%)  0 0/28 (0.00%)  0 0/30 (0.00%)  0 1/29 (3.45%)  1 2/28 (7.14%)  2 1/74 (1.35%)  1 0/120 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders                 
Hypertension  1  1/27 (3.70%)  1 0/28 (0.00%)  0 1/30 (3.33%)  1 1/29 (3.45%)  1 1/28 (3.57%)  1 0/74 (0.00%)  0 7/120 (5.83%)  8 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01107457     History of Changes
Other Study ID Numbers: 12060
I1F-MC-RHAJ ( Other Identifier: Eli Lilly and Company )
First Submitted: April 14, 2010
First Posted: April 21, 2010
Results First Submitted: April 20, 2016
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017