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Trial record 13 of 29 for:    LY2439821

A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3) (UNCOVER-3)

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: NCT01646177
Recruitment Status : Active, not recruiting
First Posted : July 20, 2012
Results First Posted : October 21, 2016
Last Update Posted : November 2, 2018
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 Drug: Placebo
Drug: 50 mg etanercept
Drug: 80 mg ixekizumab
Enrollment 1346
Recruitment Details  
Pre-assignment Details This study has 4 periods: Period 1 - Screening; Period 2 - Blinded Induction Dosing Period (Weeks 0 to 12); Period 3 - Long-Term Extension Period (Weeks 12 to 264); Period 4 - Post-Treatment Follow-Up Period up to 12 weeks after the last treatment period visit.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Period Title: Blinded Induction Dosing (Week 0-12)
Started 193 382 386 385
Completed 183 369 360 363
Not Completed 10 13 26 22
Reason Not Completed
Adverse Event             2             4             9             8
Protocol Violation             1             3             8             7
Withdrawal by Subject             3             2             4             4
Physician Decision             1             2             1             2
Lack of Efficacy             0             0             2             1
Lost to Follow-up             3             2             2             0
Period Title: Long-Term Extension Period (Week 12-264)
Started 0 [1] 0 [1] 0 [1] 0 [1]
Completed 0 [1] 0 [1] 0 [1] 0 [1]
Not Completed 0 0 0 0
[1]
Data for this period is not yet available.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W) Total
Hide Arm/Group Description Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8).

Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Total of all reporting groups
Overall Number of Baseline Participants 193 382 386 385 1346
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants 382 participants 386 participants 385 participants 1346 participants
46.4  (12.11) 45.8  (13.84) 45.6  (12.76) 45.6  (13.10) 45.8  (13.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 382 participants 386 participants 385 participants 1346 participants
Female
56
  29.0%
113
  29.6%
128
  33.2%
131
  34.0%
428
  31.8%
Male
137
  71.0%
269
  70.4%
258
  66.8%
254
  66.0%
918
  68.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 382 participants 386 participants 385 participants 1346 participants
Hispanic or Latino
25
  13.0%
52
  13.6%
50
  13.0%
57
  14.8%
184
  13.7%
Not Hispanic or Latino
133
  68.9%
263
  68.8%
269
  69.7%
259
  67.3%
924
  68.6%
Unknown or Not Reported
35
  18.1%
67
  17.5%
67
  17.4%
69
  17.9%
238
  17.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 382 participants 386 participants 385 participants 1346 participants
American Indian or Alaska Native
1
   0.5%
4
   1.0%
4
   1.0%
1
   0.3%
10
   0.7%
Asian
7
   3.6%
11
   2.9%
11
   2.8%
12
   3.1%
41
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
1
   0.3%
4
   1.0%
6
   0.4%
Black or African American
8
   4.1%
10
   2.6%
9
   2.3%
5
   1.3%
32
   2.4%
White
176
  91.2%
351
  91.9%
360
  93.3%
361
  93.8%
1248
  92.7%
More than one race
1
   0.5%
5
   1.3%
1
   0.3%
2
   0.5%
9
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 193 participants 382 participants 386 participants 385 participants 1346 participants
Argentina 2 7 6 6 21
Chile 11 21 22 22 76
Mexico 1 2 1 1 5
Bulgaria 9 12 14 13 48
Germany 45 87 90 90 312
Hungary 18 31 31 33 113
Poland 5 10 11 13 39
Russian Federation 11 22 20 24 77
Canada 22 44 44 42 152
United States 69 146 147 141 503
1.Primary Outcome
Title Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
Hide Description The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 193 382 386 385
Measure Type: Number
Unit of Measure: Participants
13 159 291 310
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 193 382 386 385
Measure Type: Number
Unit of Measure: Participants
14 204 325 336
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
Hide Description The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 193 382 386 385
Measure Type: Number
Unit of Measure: Participants
0 33 139 155
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 193 382 386 385
Measure Type: Number
Unit of Measure: Participants
6 98 252 262
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
Hide Description The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 193 382 386 385
Measure Type: Number
Unit of Measure: Participants
0 28 135 145
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
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.” Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or did not follow the protocol, and had an Itch NRS score >=4 at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 158 312 313 320
Measure Type: Number
Unit of Measure: Participants
33 200 250 264
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (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), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of DLQI.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 191 376 375 377
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-1.7  (0.32) -8.0  (0.23) -9.6  (0.23) -10.2  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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]
8.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Hide Description The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had fingernail involvement at baseline and had at least one post-dose measurement of NAPSI.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 115 233 226 228
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
1.6362  (1.0991) -6.4015  (0.7716) -9.9793  (0.7838) -10.4145  (0.7820)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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]
9.Secondary Outcome
Title Percent of Body Surface Area (BSA) Involvement of Psoriasis
Hide Description Percentage involvement of psoriasis on each participants body surface area 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 Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of BSA.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 192 378 377 380
Least Squares Mean (Standard Error)
Unit of Measure: Percent
-0.7  (1.03) -16.4  (0.73) -23.2  (0.73) -23.2  (0.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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]
10.Secondary Outcome
Title Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
Hide Description PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had scalp psoriasis at baseline and had at least one post-dose measurement of PSSI.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 175 345 344 344
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-5.0  (0.53) -15.9  (0.38) -18.2  (0.38) -18.8  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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]
11.Secondary Outcome
Title Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
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. LS Means in total QIDS-SR16 score were calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of QIDS-SR16. Participants with missing QIDS-SR16 data were imputed by Last Observation Carried Forward (LOCF) method.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 184 379 373 373
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-0.3  (0.20) -0.5  (0.14) -0.9  (0.14) -1.3  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)
Hide Description The WPAI-PSO is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days. It has four domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 and ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of WPAI-PSO. Participants with missing WPAI-PSO data were imputed by Last Observation Carried Forward (LOCF) method.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 184 376 375 373
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Absenteeism Score 0.0  (0.82) -2.8  (0.62) -2.0  (0.60) -2.5  (0.61)
Activity Impairment Score -2.5  (1.30) -21.1  (0.91) -23.3  (0.92) -24.5  (0.92)
Presenteeism Score -0.8  (1.37) -16.4  (1.04) -16.0  (1.01) -18.1  (1.04)
Work Productively Loss Score 0.6  (1.59) -17.4  (1.20) -16.7  (1.16) -19.3  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
Comments Includes analysis only from Absenteeism Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Comments Includes analysis only from Absenteeism Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Comments Includes analysis only from Absenteeism Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
Comments Includes analysis only from Activity Impairment Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Comments Includes analysis only from Activity Impairment Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Comments Includes analysis only from Activity Impairment Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
Comments Includes analysis only from Presenteeism Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Comments Includes analysis only from Presenteeism Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Comments Includes analysis only from Presenteeism Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
Comments Includes analysis only from Work Productively Loss Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Comments Includes analysis only from Work Productively Loss Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Comments Includes analysis only from Work Productively Loss Score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
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. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of SF-36. Participants with missing SF-36 data were imputed by Last Observation Carried Forward (LOCF) method.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 179 365 362 357
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
PCS -0.1993  (0.5077) 3.1176  (0.3568) 4.1143  (0.3587) 3.9620  (0.3604)
MCS 1.1305  (0.5768) 2.6486  (0.4047) 3.7961  (0.4074) 4.2772  (0.4093)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
Comments Includes analysis only from PCS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Comments Includes analysis only from PCS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Comments Includes analysis only from PCS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
Comments Includes analysis only from MCS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Comments Includes analysis only from MCS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Comments Includes analysis only from MCS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Severity
Hide Description The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Means in Patient's Global Assessment of Disease Severity score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of Patient's Global Assessment of Disease Severity.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 192 377 375 376
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-0.5  (0.08) -2.3  (0.06) -3.1  (0.06) -3.1  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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]
15.Secondary Outcome
Title Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement
Hide Description 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 to 72. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 54 95 87 96
Measure Type: Number
Unit of Measure: Participants
26 77 75 78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
16.Secondary Outcome
Title Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement
Hide Description 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 to 72. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 54 95 87 96
Measure Type: Number
Unit of Measure: Participants
19 63 69 72
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
17.Secondary Outcome
Title Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement
Hide Description 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 to 72. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 54 95 87 96
Measure Type: Number
Unit of Measure: Participants
15 57 54 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50 mg Etanercept
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
18.Secondary Outcome
Title Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies
Hide Description The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment and had evaluable data.
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description:

Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.

Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.

Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.

Overall Number of Participants Analyzed 191 378 378 378
Measure Type: Number
Unit of Measure: Participants
2 8 52 23
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were summarized based on all participants in the safety population (a subset of all randomized) who received at least one dose of study treatment in the induction period.
 
Arm/Group Title Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Hide Arm/Group Description

Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 (Q2W) until Week 12.

Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).

Placebo: Administered SC

Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2.

50 mg etanercept: Administered SC

Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q4W until Week 264.

80 mg ixekizumab: Administered SC

Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection Q2W until Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).

80 mg ixekizumab: Administered SC

All-Cause Mortality
Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/193 (2.59%)      5/382 (1.31%)      6/382 (1.57%)      9/384 (2.34%)    
Cardiac disorders         
Acute myocardial infarction  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 0/384 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Crohn's disease  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Inguinal hernia  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 0/384 (0.00%)  0
Pancreatitis acute  1  0/193 (0.00%)  0 0/382 (0.00%)  0 1/382 (0.26%)  1 0/384 (0.00%)  0
Hepatobiliary disorders         
Biliary colic  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Hepatic function abnormal  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Infections and infestations         
Appendicitis  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Cellulitis  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 0/384 (0.00%)  0
Erysipelas  1  0/193 (0.00%)  0 0/382 (0.00%)  0 1/382 (0.26%)  1 0/384 (0.00%)  0
Pyelonephritis acute  1  0/193 (0.00%)  0 0/382 (0.00%)  0 1/382 (0.26%)  1 0/384 (0.00%)  0
Skin bacterial infection  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 0/384 (0.00%)  0
Urosepsis  1  0/193 (0.00%)  0 0/382 (0.00%)  0 1/382 (0.26%)  1 0/384 (0.00%)  0
Injury, poisoning and procedural complications         
Fall  1  1/193 (0.52%)  1 1/382 (0.26%)  1 0/382 (0.00%)  0 1/384 (0.26%)  1
Meniscus injury  1  0/193 (0.00%)  0 1/382 (0.26%)  1 0/382 (0.00%)  0 0/384 (0.00%)  0
Subdural haematoma  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Tibia fracture  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 0/384 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Hepatic adenoma  1  0/193 (0.00%)  0 1/382 (0.26%)  1 0/382 (0.00%)  0 0/384 (0.00%)  0
Uterine leiomyoma  1  0/56 (0.00%)  0 1/113 (0.88%)  1 0/128 (0.00%)  0 0/130 (0.00%)  0
Nervous system disorders         
Cerebral artery embolism  1  0/193 (0.00%)  0 0/382 (0.00%)  0 1/382 (0.26%)  2 0/384 (0.00%)  0
Psychiatric disorders         
Anxiety  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Bipolar disorder  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Depression  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Renal and urinary disorders         
Nephrolithiasis  1  0/193 (0.00%)  0 1/382 (0.26%)  1 0/382 (0.00%)  0 0/384 (0.00%)  0
Renal failure acute  1  0/193 (0.00%)  0 0/382 (0.00%)  0 1/382 (0.26%)  1 0/384 (0.00%)  0
Renal impairment  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Reproductive system and breast disorders         
Ovarian cyst  1  0/56 (0.00%)  0 1/113 (0.88%)  1 0/128 (0.00%)  0 0/130 (0.00%)  0
Prostatitis  1  0/137 (0.00%)  0 0/269 (0.00%)  0 1/254 (0.39%)  1 0/254 (0.00%)  0
Skin and subcutaneous tissue disorders         
Leukocytoclastic vasculitis  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  1
Palmoplantar keratoderma  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 0/384 (0.00%)  0
Psoriasis  1  1/193 (0.52%)  1 0/382 (0.00%)  0 0/382 (0.00%)  0 0/384 (0.00%)  0
Skin lesion  1  0/193 (0.00%)  0 0/382 (0.00%)  0 0/382 (0.00%)  0 1/384 (0.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 50 mg Etanercept 80 mg Ixekizumab Dosing Regimen 2 (Q4W) 80 mg Ixekizumab Dosing Regimen 1 (Q2W)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/193 (7.25%)      54/382 (14.14%)      66/382 (17.28%)      58/384 (15.10%)    
General disorders         
Injection site reaction  1  3/193 (1.55%)  23 41/382 (10.73%)  211 43/382 (11.26%)  101 37/384 (9.64%)  115
Infections and infestations         
Nasopharyngitis  1  11/193 (5.70%)  12 19/382 (4.97%)  22 29/382 (7.59%)  29 26/384 (6.77%)  31
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01646177     History of Changes
Other Study ID Numbers: 13685
I1F-MC-RHBC ( Other Identifier: Eli Lilly and Company )
First Submitted: July 18, 2012
First Posted: July 20, 2012
Results First Submitted: April 20, 2016
Results First Posted: October 21, 2016
Last Update Posted: November 2, 2018