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Trial record 20 of 29 for:    LY2439821

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

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: NCT02718898
Recruitment Status : Completed
First Posted : March 24, 2016
Results First Posted : March 23, 2018
Last Update Posted : March 23, 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
Conditions Genital Psoriasis
Psoriasis
Interventions Drug: Ixekizumab
Drug: Placebo
Enrollment 149
Recruitment Details Results reported are for primary outcome up to week 12 (Blinded treatment period), data beyond week 12 will be reported after final analysis for week 52 results.
Pre-assignment Details 12 week Blinded Treatment period, followed by 40 week Open Label Treatment Period, followed by 12 week Post treatment follow-up period.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC. Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Period Title: Overall Study
Started 74 75
Completed 65 74
Not Completed 9 1
Reason Not Completed
Adverse Event             5             1
Physician Decision             1             0
Lack of Efficacy             1             0
Lost to Follow-up             2             0
Arm/Group Title Placebo Ixekizumab 80mg Q2W Total
Hide Arm/Group Description Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC. Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period. Total of all reporting groups
Overall Number of Baseline Participants 74 75 149
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 75 participants 149 participants
44.4  (12.55) 43.1  (12.95) 43.7  (12.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 75 participants 149 participants
Female 17 19 36
Male 57 56 113
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 75 participants 149 participants
Hispanic or Latino 14 13 27
Not Hispanic or Latino 57 60 117
Unknown or Not Reported 3 2 5
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 75 participants 149 participants
American Indian or Alaska Native 0 1 1
Asian 7 3 10
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 2 0 2
White 64 67 131
More than one race 1 4 5
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 75 participants 149 participants
Canada 16 13 29
Puerto Rico 4 7 11
Austria 4 4 8
Netherlands 2 3 5
Turkey 3 4 7
Belgium 3 4 7
United States 31 31 62
Australia 11 9 20
sPGA of Genitalia   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 74 participants 75 participants 149 participants
3.5  (0.53) 3.4  (0.57) 3.4  (0.57)
[1]
Measure Description: The Static Physician Global Assessment (sPGA) of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis is assessed as follows: 0 = clear,1 = minimal,2 = mild,3 = moderate,4 = severe,5 = very severe.
1.Primary Outcome
Title Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
Hide Description

sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.

sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 74 75
Measure Type: Count of Participants
Unit of Measure: Participants
6 55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
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 Odds Ratio (OR)
Estimated Value 33.80
Confidence Interval (2-Sided) 95%
12.39 to 92.23
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Achieving Overall sPGA (0,1)
Hide Description

The overall sPGA is the physician’s global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.

Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 74 75
Measure Type: Count of Participants
Unit of Measure: Participants
2 55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
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 Odds Ratio (OR)
Estimated Value 102.55
Confidence Interval (2-Sided) 95%
22.79 to 461.43
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS)
Hide Description GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity).
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline GPSS Itch NRS Score >= 3.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 60 62
Measure Type: Count of Participants
Unit of Measure: Participants
5 37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
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 Odds Ratio (OR)
Estimated Value 16.27
Confidence Interval (2-Sided) 95%
5.71 to 46.40
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2
Hide Description

The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always.

*The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire).

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline GenPs-SFQ Item 2 Score >= 2.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 42 37
Measure Type: Count of Participants
Unit of Measure: Participants
9 29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
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 Odds Ratio (OR)
Estimated Value 13.57
Confidence Interval (2-Sided) 95%
4.57 to 40.29
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)
Hide Description

GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity.

The GPSIS Sexual Activity Avoidance Subscale includes 2 items:

Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4)

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline GPSIS sexual activity avoidance subscale score >= 3.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 35 30
Measure Type: Count of Participants
Unit of Measure: Participants
9 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
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 Odds Ratio (OR)
Estimated Value 9.84
Confidence Interval (2-Sided) 95%
3.08 to 31.40
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Hide Description

DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment.

Response categories include:

0 = not at all; 1 = a little; 2 = a lot; 3 = very much; “not relevant” responses scored as “0” and total score range of 0 to 30; higher scores indicate poor quality of life.

Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.

Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline observation for DLQI.
Arm/Group Title Placebo Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 70 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.4  (0.62) -9.7  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.4
Confidence Interval (2-Sided) 95%
-10.1 to -6.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.86
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
Hide Description mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline observation for mGPASI.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 73 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.9  (1.56) -23.9  (1.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.0
Confidence Interval (2-Sided) 95%
-24.3 to -15.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.15
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With at Least a 2-Point Change in Patient’s Global Assessment of Genital Psoriasis (PatGA-Genital)
Hide Description Patient’s Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis “today” by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe).
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline PatGA-Genital score >= 2.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 73 72
Measure Type: Count of Participants
Unit of Measure: Participants
11 51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
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 Odds Ratio (OR)
Estimated Value 13.95
Confidence Interval (2-Sided) 95%
6.12 to 31.80
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
Hide Description

SF-36 is a participant-reported outcome measure evaluating a 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.

Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.

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

All randomized participants with baseline and post baseline measurement for SF-36 PCS.

mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation , Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 71 72
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.687  (0.7998) 5.193  (0.7942)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.506
Confidence Interval (2-Sided) 95%
2.264 to 6.748
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.1339
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
Hide Description

SF-36 is a participant-reported outcome measure evaluating a 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 MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.

Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.

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

All randomized participants with baseline and post baseline measurement for SF-36 MCS.

mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 71 72
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.186  (0.7333) 3.982  (0.7281)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.797
Confidence Interval (2-Sided) 95%
-0.253 to 3.847
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0367
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
Hide Description GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline observation for GPSS total or individual item scores.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 66 69
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total Score -2.82  (2.190) -31.57  (2.070)
Itch -0.21  (0.290) -4.02  (0.274)
Pain -0.34  (0.294) -3.84  (0.278)
Discomfort -0.42  (0.298) -4.27  (0.282)
Stinging -0.51  (0.298) -3.74  (0.281)
Burning -0.53  (0.289) -3.73  (0.273)
Redness -0.63  (0.287) -4.45  (0.272)
Scaling -0.02  (0.273) -3.80  (0.259)
Cracking -0.19  (0.280) -3.74  (0.264)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Total Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -28.75
Confidence Interval (2-Sided) 95%
-34.72 to -22.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.015
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Itch
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.81
Confidence Interval (2-Sided) 95%
-4.60 to -3.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.399
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.50
Confidence Interval (2-Sided) 95%
-4.30 to -2.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.405
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Discomfort
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.85
Confidence Interval (2-Sided) 95%
-4.66 to -3.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.410
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Stinging
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.23
Confidence Interval (2-Sided) 95%
-4.04 to -2.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.410
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Burning
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.20
Confidence Interval (2-Sided) 95%
-3.99 to -2.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.397
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Redness
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.81
Confidence Interval (2-Sided) 95%
-4.59 to -3.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.395
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Scaling
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.78
Confidence Interval (2-Sided) 95%
-4.53 to -3.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.377
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80mg Q2W
Comments Cracking
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.55
Confidence Interval (2-Sided) 95%
-4.31 to -2.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.385
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status
Hide Description

sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.

sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and either had baseline and at least 1 post-baseline evaluable samples or had no evaluable baseline and all negative post-baseline anti-drug antibody negative samples.
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description:
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Overall Number of Participants Analyzed 73 75
Measure Type: Count of Participants
Unit of Measure: Participants
TE-ADA positive Number Analyzed 0 participants 6 participants
5
TE-ADA negative Number Analyzed 73 participants 69 participants
6 50
TE-ADA inconclusive Number Analyzed 0 participants 0 participants
NAb positive Number Analyzed 0 participants 0 participants
NAb negative Number Analyzed 0 participants 0 participants
NAb inconclusive Number Analyzed 0 participants 6 participants
5
Time Frame Up to 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ixekizumab 80mg Q2W
Hide Arm/Group Description Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC. Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
All-Cause Mortality
Placebo Ixekizumab 80mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)      0/75 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ixekizumab 80mg Q2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/74 (1.35%)      0/75 (0.00%)    
Gastrointestinal disorders     
Pancreatitis acute  1  1/74 (1.35%)  1 0/75 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ixekizumab 80mg Q2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/74 (21.62%)      19/75 (25.33%)    
Gastrointestinal disorders     
Diarrhoea  1  4/74 (5.41%)  4 1/75 (1.33%)  2
General disorders     
Injection site reaction  1  0/74 (0.00%)  0 5/75 (6.67%)  7
Infections and infestations     
Nasopharyngitis  1  4/74 (5.41%)  4 2/75 (2.67%)  2
Upper respiratory tract infection  1  5/74 (6.76%)  5 11/75 (14.67%)  11
Nervous system disorders     
Headache  1  4/74 (5.41%)  6 3/75 (4.00%)  3
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
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.
Disclosures are prohibited until after the sponsor discloses the primary and secondary publications of clinical trial data.
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: NCT02718898     History of Changes
Other Study ID Numbers: 16010
I1F-MC-RHBQ ( Other Identifier: Eli Lilly and Company )
2015-002628-14 ( EudraCT Number )
First Submitted: March 21, 2016
First Posted: March 24, 2016
Results First Submitted: February 17, 2018
Results First Posted: March 23, 2018
Last Update Posted: March 23, 2018