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Trial record 21 of 29 for:    LY2439821

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis (IXORA-S)

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ClinicalTrials.gov Identifier: NCT02561806
Recruitment Status : Completed
First Posted : September 28, 2015
Results First Posted : February 28, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Ixekizumab
Drug: Ustekinumab
Drug: Placebo
Enrollment 302
Recruitment Details Induction period occurring from week 0 to week 12 followed by maintenance period occurring week 12 to week 52 followed by post-treatment follow-up period occurring from last treatment period visit (week 52) or Early termination visit, for a minimum of 12 weeks following that visit.
Pre-assignment Details  
Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description 45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding. 160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Period Title: Induction Period
Started 166 136
Received At Least One Dose of Study Drug 166 135
Completed 164 131
Not Completed 2 5
Reason Not Completed
Adverse Event             0             2
Lack of Efficacy             1             0
Withdrawal by Subject             0             2
Site staff became unblinded             1             0
Randomized but not treated             0             1
Period Title: Maintenance Period
Started 164 131
Completed 151 123
Not Completed 13 8
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             3             1
Lost to Follow-up             2             2
Protocol Violation             1             0
Withdrawal by Subject             5             3
Site staff became unblinded             0             1
Period Title: Post-Treatment Follow-up
Started 157 [1] 60 [1]
Completed 155 59
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             1             0
[1]
Participants who discontinued previous periods had option to enter post treatment follow-up period.
Arm/Group Title Ustekinumab Ixekizumab Total
Hide Arm/Group Description 45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding. 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding. Total of all reporting groups
Overall Number of Baseline Participants 166 136 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 136 participants 302 participants
44  (13.25) 42.7  (12.67) 43.4  (12.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 136 participants 302 participants
Female 54 46 100
Male 112 90 202
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 136 participants 302 participants
American Indian or Alaska Native 0 0 0
Asian 5 4 9
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 3 4
White 157 125 282
More than one race 1 2 3
Unknown or Not Reported 2 2 4
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Hungary Number Analyzed 166 participants 136 participants 302 participants
12 11 23
United Kingdom Number Analyzed 166 participants 136 participants 302 participants
4 2 6
Switzerland Number Analyzed 166 participants 136 participants 302 participants
6 5 11
Spain Number Analyzed 166 participants 136 participants 302 participants
13 12 25
Canada Number Analyzed 166 participants 136 participants 302 participants
27 25 52
Austria Number Analyzed 166 participants 136 participants 302 participants
6 6 12
Netherlands Number Analyzed 166 participants 136 participants 302 participants
0 1 1
Sweden Number Analyzed 166 participants 136 participants 302 participants
4 2 6
Belgium Number Analyzed 166 participants 136 participants 302 participants
4 2 6
Poland Number Analyzed 166 participants 136 participants 302 participants
21 17 38
Italy Number Analyzed 166 participants 136 participants 302 participants
4 4 8
France Number Analyzed 166 participants 136 participants 302 participants
25 23 48
Germany Number Analyzed 166 participants 136 participants 302 participants
40 26 66
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 166 participants 136 participants 302 participants
89.4  (24.5) 85.8  (20.30) 87.8  (22.90)
Weight Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
<= 100 kg Number Analyzed 166 participants 135 participants 301 participants
121 104 225
> 100 kg Number Analyzed 166 participants 135 participants 301 participants
45 31 76
[1]
Measure Analysis Population Description: All randomized participants who had baseline data.
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 166 participants 135 participants 301 participants
29.7  (6.97) 28.8  (5.55) 29.3  (6.38)
[1]
Measure Analysis Population Description: All randomized participants who had baseline data.
Duration of psoriasis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 136 participants 302 participants
18.2  (12.0) 18.0  (11.14) 18.1  (11.60)
Age group at psoriasis onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 136 participants 302 participants
<40 years (Type 1 psoriasis) 134 113 247
>=40 years (Type 2 psoriasis) 32 23 55
Psoriasis Area & Severity Index (PASI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 166 participants 136 participants 302 participants
19.8  (9.02) 19.9  (8.15) 19.9  (8.62)
[1]
Measure Description: PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, & legs). For each region the % area of skin involved was estimated from 0(0%) to 6(90%-100%) & severity was estimated by clinical signs of erythema, induration & scaling with scores range from 0 to 4 ("no" to "severe" involvement). Each area is scored & scores were combined for final PASI (sum of severity parameters for each region * area score * weighing factor [head(0.1), upper limbs(0.2), trunk(0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (most severe disease).
1.Primary Outcome
Title Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
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 (no involvement) to 4 (severe involvement). 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 Ps) to 72 (the most severe disease).
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 baseline and post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Overall Number of Participants Analyzed 166 136
Measure Type: Number
Unit of Measure: percentage of participants
42.2 72.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Ixekizumab
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority margin was -12.6% for 97.5% confidence interval
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.321
Confidence Interval (2-Sided) 97.5%
0.198 to 0.445
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline
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 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Week 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 a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:

45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.

Ustekinumab: Administered SC

160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.

Ixekizumab: Administered SC

Overall Number of Participants Analyzed 166 136
Measure Type: Number
Unit of Measure: percentage of participants
68.7 88.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.285
Confidence Interval (2-Sided) 95%
1.130 to 1.439
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline
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 (no involvement) to 4 (severe involvement). 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 Ps) to 72 (the most severe disease).
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 a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 166 136
Measure Type: Number
Unit of Measure: percentage of participants
14.5 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.699
Confidence Interval (2-Sided) 95%
1.423 to 3.975
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline
Hide Description The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:

45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.

Ustekinumab: Administered SC

160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.

Ixekizumab: Administered SC

Overall Number of Participants Analyzed 166 134
Measure Type: Number
Unit of Measure: percentage of participants
57.2 83.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.469
Confidence Interval (2-Sided) 95%
1.244 to 1.695
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With a sPGA (0) Remission
Hide Description The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.
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 a post-baseline measurement for sPGA (0). Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 166 136
Measure Type: Number
Unit of Measure: percentage of participants
18.1 41.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 3.421
Confidence Interval (2-Sided) 95%
1.353 to 5.488
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis
Hide Description

The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a 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.

ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group 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 & had a baseline & post-baseline measurement for BSA affected by Ps.

mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Overall Number of Participants Analyzed 164 135
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Body Surface Affected
-16.92
(-18.50 to -15.34)
-22.55
(-24.34 to -20.76)
7.Secondary Outcome
Title Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
Hide Description

The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants(Pts) who had psoriasis in palmoplantar regions at baseline & received at least 1 dose of study drug & had baseline & post-baseline PPASI data.

mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, Pts who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:

45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.

Ustekinumab: Administered SC

160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.

Ixekizumab: Administered SC

Overall Number of Participants Analyzed 28 35
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.34
(-9.64 to -7.03)
-10.31
(-11.63 to -8.99)
8.Secondary Outcome
Title Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
Hide Description

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who had psoriasis in scalp region at baseline & received at least 1 dose of study drug & had baseline & post-baseline PSSI data.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 152 119
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-16.00
(-17.24 to -14.77)
-19.29
(-20.67 to -17.92)
9.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score
Hide Description

NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who had nail psoriasis at baseline & received at least 1 dose of study drug and had baseline & post-baseline NAPSI measurement.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.

160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.

Ixekizumab: Administered SC

Overall Number of Participants Analyzed 103 84
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-5.02
(-7.19 to -2.84)
-12.24
(-14.72 to -9.77)
10.Secondary Outcome
Title Change From Baseline in Itch Numeric Rating Scale (NRS)
Hide Description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 a post-baseline measurement for Itch NRS.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 165 135
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.12
(-4.51 to -3.74)
-4.56
(-4.98 to -4.14)
11.Secondary Outcome
Title Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)
Hide Description

Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain).

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for skin pain VAS.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 165 135
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-29.92
(-32.81 to -27.04)
-33.32
(-36.44 to -30.20)
12.Secondary Outcome
Title Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1)
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life.
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 a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Overall Number of Participants Analyzed 166 136
Measure Type: Number
Unit of Measure: percentage of participants
44.6 61.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ustekinumab, Ixekizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.391
Confidence Interval (2-Sided) 95%
1.085 to 1.698
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale
Hide Description

The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for HADS depression subscale.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Overall Number of Participants Analyzed 162 134
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.96
(-1.38 to -0.54)
-1.20
(-1.65 to -0.74)
14.Secondary Outcome
Title Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.
Hide Description

The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and a post-baseline measurement for HADS anxiety subscale.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Overall Number of Participants Analyzed 162 134
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.90
(-1.37 to -0.43)
-1.27
(-1.80 to -0.73)
15.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;
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. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for SF-36 PCS score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was be used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 164 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.10
(1.97 to 4.23)
5.03
(3.80 to 6.26)
16.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score
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. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for SF36 MCS score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 164 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.36
(0.87 to 3.86)
2.96
(1.33 to 4.59)
17.Secondary Outcome
Title Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)
Hide Description

The Patient 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.

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for PatGA.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 164 135
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.60
(-2.78 to -2.42)
-3.07
(-3.26 to -2.88)
18.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index
Hide Description

The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health).

ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for EQ-5D 5L "Bolt On" PSO-Index.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
Overall Number of Participants Analyzed 165 134
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.11
(0.09 to 0.13)
0.15
(0.13 to 0.17)
19.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS
Hide Description The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for EQ-5D 5L VAS.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injectio was used for blinding.
Overall Number of Participants Analyzed 163 134
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
8.75
(5.77 to 11.74)
12.24
(9.01 to 15.46)
20.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score
Hide Description

The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health).

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 & had baseline & post-baseline EQ-5D 5L UK population-based index score measurement.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Overall Number of Participants Analyzed 165 134
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.12
(0.09 to 0.15)
0.15
(0.12 to 0.18)
21.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and a post-baseline measurement for WPAI-PSO absenteeism score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 90 87
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.42
(-4.55 to 1.72)
-0.46
(-3.51 to 2.60)
22.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for WPAI-PSO presenteeism score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 98 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-15.53
(-18.33 to -12.72)
-16.91
(-19.71 to -14.11)
23.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group 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 baseline and post-baseline measurement for WPAI-PSO work impairment score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 90 87
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-15.05
(-19.25 to -10.85)
-16.27
(-20.39 to -12.16)
24.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).

ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants(Pts) who received at least 1 dose of study drug & had baseline & post-baseline data for WPAI-PSO impairment in activities performed outside work.

mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, pts who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ustekinumab Ixekizumab
Hide Arm/Group Description:
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Overall Number of Participants Analyzed 154 127
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-19.14
(-21.79 to -16.48)
-23.06
(-26.04 to -20.09)
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least one dose study drug.
 
Arm/Group Title Ustekinumab - Induction Ixekizumab - Induction Ustekinumab - Maintenance Ixekizumab - Maintenance Ustekinumab - Post Treatment Follow up Ixekizumab - Post Treatment Follow up
Hide Arm/Group Description 45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding.

160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks.

Placebo for Ustekinumab injection was used for blinding.

45 milligram (mg) Ustekinumab given as Subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding. 80 mg Ixekizumab given as a single SC injection once every 4 weeks. Placebo for Ustekinumab injection was used for blinding. Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment. Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
All-Cause Mortality
Ustekinumab - Induction Ixekizumab - Induction Ustekinumab - Maintenance Ixekizumab - Maintenance Ustekinumab - Post Treatment Follow up Ixekizumab - Post Treatment Follow up
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
Ustekinumab - Induction Ixekizumab - Induction Ustekinumab - Maintenance Ixekizumab - Maintenance Ustekinumab - Post Treatment Follow up Ixekizumab - Post Treatment Follow up
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   0/166 (0.00%)      2/135 (1.48%)      6/164 (3.66%)      7/131 (5.34%)      2/157 (1.27%)      0/60 (0.00%)    
Cardiac disorders             
Angina unstable  1  0/166 (0.00%)  0 1/135 (0.74%)  1 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Myocardial infarction  1  0/166 (0.00%)  0 0/135 (0.00%)  0 1/164 (0.61%)  1 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Gastrointestinal disorders             
Rectal haemorrhage  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 1/131 (0.76%)  1 0/157 (0.00%)  0 0/60 (0.00%)  0
Tooth impacted  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis acute  1  0/166 (0.00%)  0 0/135 (0.00%)  0 1/164 (0.61%)  1 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Cholelithiasis  1  0/166 (0.00%)  0 0/135 (0.00%)  0 1/164 (0.61%)  1 1/131 (0.76%)  1 0/157 (0.00%)  0 0/60 (0.00%)  0
Infections and infestations             
Erysipelas  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 1/157 (0.64%)  1 0/60 (0.00%)  0
Gastroenteritis bacterial  1  0/166 (0.00%)  0 1/135 (0.74%)  1 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Injury, poisoning and procedural complications             
Ankle fracture  1  0/166 (0.00%)  0 0/135 (0.00%)  0 1/164 (0.61%)  1 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Clavicle fracture  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Humerus fracture  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Metabolism and nutrition disorders             
Obesity  1  0/166 (0.00%)  0 0/135 (0.00%)  0 1/164 (0.61%)  1 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthritis  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 1/131 (0.76%)  1 0/157 (0.00%)  0 0/60 (0.00%)  0
Pseudarthrosis  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 1/131 (0.76%)  1 0/157 (0.00%)  0 0/60 (0.00%)  0
Psoriatic arthropathy  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 1/157 (0.64%)  1 0/60 (0.00%)  0
Rotator cuff syndrome  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 1/131 (0.76%)  1 0/157 (0.00%)  0 0/60 (0.00%)  0
Nervous system disorders             
Carotid arteriosclerosis  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Carotid artery stenosis  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Ischaemic stroke  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Psychiatric disorders             
Depression  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 1/131 (0.76%)  1 0/157 (0.00%)  0 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  0/166 (0.00%)  0 0/135 (0.00%)  0 1/164 (0.61%)  1 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Skin and subcutaneous tissue disorders             
Eczema  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 1/131 (0.76%)  1 0/157 (0.00%)  0 0/60 (0.00%)  0
Vascular disorders             
Hypertensive crisis  1  0/166 (0.00%)  0 0/135 (0.00%)  0 0/164 (0.00%)  0 0/131 (0.00%)  0 0/157 (0.00%)  0 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ustekinumab - Induction Ixekizumab - Induction Ustekinumab - Maintenance Ixekizumab - Maintenance Ustekinumab - Post Treatment Follow up Ixekizumab - Post Treatment Follow up
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   55/166 (33.13%)      40/135 (29.63%)      65/164 (39.63%)      50/131 (38.17%)      0/157 (0.00%)      0/60 (0.00%)    
General disorders             
Injection site erythema  1  0/166 (0.00%)  0 10/135 (7.41%)  15 0/164 (0.00%)  0 2/131 (1.53%)  4 0/157 (0.00%)  0 0/60 (0.00%)  0
Infections and infestations             
Nasopharyngitis  1  34/166 (20.48%)  39 23/135 (17.04%)  27 40/164 (24.39%)  52 36/131 (27.48%)  47 0/157 (0.00%)  0 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  8/166 (4.82%)  8 3/135 (2.22%)  3 11/164 (6.71%)  16 8/131 (6.11%)  8 0/157 (0.00%)  0 0/60 (0.00%)  0
Back pain  1  4/166 (2.41%)  5 2/135 (1.48%)  2 9/164 (5.49%)  11 5/131 (3.82%)  5 0/157 (0.00%)  0 0/60 (0.00%)  0
Nervous system disorders             
Headache  1  12/166 (7.23%)  17 7/135 (5.19%)  9 12/164 (7.32%)  19 10/131 (7.63%)  17 0/157 (0.00%)  0 0/60 (0.00%)  0
Vascular disorders             
Hypertension  1  4/166 (2.41%)  4 2/135 (1.48%)  2 11/164 (6.71%)  11 4/131 (3.05%)  5 0/157 (0.00%)  0 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
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
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02561806     History of Changes
Other Study ID Numbers: 16012
I1F-MC-RHBS ( Other Identifier: Eli Lilly and Company )
2015-000892-28 ( EudraCT Number )
First Submitted: September 25, 2015
First Posted: September 28, 2015
Results First Submitted: June 28, 2017
Results First Posted: February 28, 2018
Last Update Posted: November 9, 2018