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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02718898
• Collaborator: (none)
• Enrollment: 149
• Locations: 34
• Arms: 2
• Duration (Months): 22.7
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Genital Psoriasis; Psoriasis	Drug: Ixekizumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Feb 22, 2017
• Actual Study Completion Date: Feb 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ixekizumab Blinded Treatment Period: 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10. At week 12, 80 mg ixekizumab and placebo given SC. Open Label Period: 80 mg ixekizumab given SC every 4 weeks (Q4W) with an option for Q2W dosing starting at week 24, week 28 or week 40.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821 ; Drug: Placebo; Administered SC
Placebo Comparator: Placebo Blinded Treatment Period: Placebo given SC at baseline followed by placebo given SC Q2W from week 2 to week 10. At week 12, 160 mg ixekizumab given SC. Open Label Period: 80 mg ixekizumab given SC Q4W with an option for Q2W dosing starting at week 24, week 28 or week 40.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821 ; Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) [Week 12]

   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.

Secondary Outcome Measures

1. Number of Participants Achieving Overall sPGA (0,1) [Week 12]

   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.

2. 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) [Week 12]

   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).

3. 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 [Week 12]

   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).

4. 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) [Week 12]

   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)

5. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score [Baseline, Week 12]

   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.

6. Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score [Baseline, Week 12]

   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.

7. Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) [Week 12]

   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).

8. Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS) [Baseline, Week 12]

   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.

9. Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS) [Baseline, Week 12]

   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.

10. Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items [Baseline, Week 12]

    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.

11. 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 [Week 12]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.

• Have moderate-to-severe psoriasis in the genital area at screening and baseline.

• Have plaque psoriasis in a nongenital area at screening and baseline.

• Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area.

• Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.

Exclusion Criteria:

• Pustular, erythrodermic, and/or guttate forms of psoriasis.

• History of drug-induced psoriasis.

• Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments).

• Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action.

• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study.

• Are currently enrolled in any other clinical trial involving an investigational product.

• Serious disorder or illness other than plaque psoriasis.

• Active or history of malignant disease within 5 years prior to baseline.

• Serious infection within the last 3 months.

• Have received a live vaccine within 3 months of baseline or plan to do so during the study.

• Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.

• Pregnant or breastfeeding (lactating) women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern California Dermatology	Santa Ana	California	United States	92701
2	Clinical Science Institute	Santa Monica	California	United States	90404
3	Olympian Clinical Research	Tampa	Florida	United States	33609
4	Advanced Medical Research	Sandy Springs	Georgia	United States	30328
5	Dawes Fretzin Clinical Research	Indianapolis	Indiana	United States	46256
6	The South Bend Clinic	South Bend	Indiana	United States	46617
7	Tufts Medical Center	Boston	Massachusetts	United States	02111
8	Oregon Medical Research Center	Portland	Oregon	United States	97223
9	Clinical Partners LLC	Johnston	Rhode Island	United States	02919
10	Modern Research Associates PLLC	Dallas	Texas	United States	75231
11	Menter Dermatology Research Institute	Dallas	Texas	United States	75246
12	Pflugerville Dermatology Clinical Research Center	Pflugerville	Texas	United States	78660
13	University of Utah	Salt Lake City	Utah	United States	84132
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Adelaide		Australia	5073
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Carlton		Australia	3053
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Darlinghurst		Australia	2010
17	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Woolloongabba		Australia	4102
18	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Graz		Austria	8036
19	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wien		Austria	1090
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wien		Austria	1130
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brussels		Belgium	1090
22	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brussels		Belgium	1200
23	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gent		Belgium	9000
24	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	London		Canada	N6A 3H7
25	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Markham		Canada	L3P1X2
26	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Montreal		Canada	H2K4L5
27	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Quebec		Canada	G1V 4X7
28	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Surrey		Canada	V3V 0C6
29	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bergen op Zoom		Netherlands	4624 VT
30	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Breda		Netherlands	4818 CK
31	GCM Medical Group PSC	San Juan		Puerto Rico	00909
32	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bursa		Turkey	16059
33	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gaziantep		Turkey	27310
34	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Istanbul		Turkey	34093

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol: Protocol - Nov 14, 2015
• Study Protocol: Protocol (a) - Jan 22, 2016
• Study Protocol: Protocol (b) - Nov 22, 2016
• Statistical Analysis Plan - Mar 8, 2017

More Information

Additional Information:

• Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02718898
• Other Study ID Numbers: 16010; I1F-MC-RHBQ; 2015-002628-14
• First Posted: Mar 24, 2016
• Last Update Posted: Sep 16, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: genital
• Additional relevant MeSH terms: Psoriasis; Ixekizumab

Study Results

Participant Flow

Pre-assignment Detail	12 week Blinded Treatment period, followed by 40 week Open Label Treatment Period, followed by 12 week Post treatment follow-up period. ttt = treatment, Pt = Participant.

Arm/Group Title	Placebo - Blinded Treatment	Ixekizumab 80mg Q2W - Blinded Treatment	Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period	Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment	Placebo - Post Treatment Follow-up	Ixeqizumab 80mg Q4W - Post Treatment Follow-up Period	Ixekizumab 80mg Q2W - Post Treatment Follow-up
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 was given by Subcutaneous injection during blinded treatment period.	Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80mg Ixekizumab and placebo was given SC during blinded treatment period.	Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.	Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.	Participants did not receive any study treatment during post treatment follow-up period.	Participants did not receive any study treatment during post treatment follow-up period.	Participants did not receive any study treatment during post treatment follow-up period.
Period Title: Blinded Treatment Period
STARTED	74	75	0	0	0	0	0
COMPLETED	65	74	0	0	0	0	0
NOT COMPLETED	9	1	0	0	0	0	0
Period Title: Blinded Treatment Period
STARTED	0	0	65	74	0	0	0
COMPLETED	0	0	62	64	0	0	0
NOT COMPLETED	0	0	3	10	0	0	0
Period Title: Blinded Treatment Period
STARTED	0	0	0	0	1	78	49
COMPLETED	0	0	0	0	0	67	44
NOT COMPLETED	0	0	0	0	1	11	5

Baseline Characteristics

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W	Total
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 Participants	74	75	149
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.4 (12.55)	43.1 (12.95)	43.7 (12.72)
Sex: Female, Male (Count of Participants)
Female	17 23%	19 25.3%	36 24.2%
Male	57 77%	56 74.7%	113 75.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 18.9%	13 17.3%	27 18.1%
Not Hispanic or Latino	57 77%	60 80%	117 78.5%
Unknown or Not Reported	3 4.1%	2 2.7%	5 3.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.3%	1 0.7%
Asian	7 9.5%	3 4%	10 6.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 2.7%	0 0%	2 1.3%
White	64 86.5%	67 89.3%	131 87.9%
More than one race	1 1.4%	4 5.3%	5 3.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Canada	16 21.6%	13 17.3%	29 19.5%
Puerto Rico	4 5.4%	7 9.3%	11 7.4%
Austria	4 5.4%	4 5.3%	8 5.4%
Netherlands	2 2.7%	3 4%	5 3.4%
Turkey	3 4.1%	4 5.3%	7 4.7%
Belgium	3 4.1%	4 5.3%	7 4.7%
United States	31 41.9%	31 41.3%	62 41.6%
Australia	11 14.9%	9 12%	20 13.4%
sPGA of Genitalia (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.53)	3.4 (0.61)	3.4 (0.57)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
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

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W
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 was given by subcutaneous injection.	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.
Measure Participants	74	75
Count of Participants [Participants]	6 8.1%	55 73.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	33.80
	Confidence Interval	(2-Sided) 95%; 12.39 to 92.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants Achieving Overall sPGA (0,1)
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

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W
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 was by given subcutaneous injection.	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.
Measure Participants	74	75
Count of Participants [Participants]	2 2.7%	55 73.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	102.55
	Confidence Interval	(2-Sided) 95%; 22.79 to 461.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

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)
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

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline GPSS Itch NRS Score >= 3.

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W
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 was by given subcutaneous injection.	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.
Measure Participants	60	62
Count of Participants [Participants]	5 6.8%	37 49.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	16.27
	Confidence Interval	(2-Sided) 95%; 5.71 to 46.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
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

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline GenPs-SFQ Item 2 Score >= 2.

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W
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 was by given subcutaneous injection.	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.
Measure Participants	42	37
Count of Participants [Participants]	9 12.2%	29 38.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	13.57
	Confidence Interval	(2-Sided) 95%; 4.57 to 40.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

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)
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

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline GPSIS sexual activity avoidance subscale score >= 3.

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W
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 was by given subcutaneous injection.	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.
Measure Participants	35	30
Count of Participants [Participants]	9 12.2%	23 30.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9.84
	Confidence Interval	(2-Sided) 95%; 3.08 to 31.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
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

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post baseline observation for DLQI.

Arm/Group Title	Placebo	Ixekizumab Q2W
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 was by given subcutaneous injection.	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.
Measure Participants	70	74
Least Squares Mean (Standard Error) [units on a scale]	-1.4 (0.62)	-9.7 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

7. Secondary Outcome

Title	Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
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

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post baseline observation for mGPASI.

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W
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 was by given subcutaneous injection.	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.
Measure Participants	73	74
Least Squares Mean (Standard Error) [units on a scale]	-3.9 (1.56)	-23.9 (1.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

8. Secondary Outcome

Title	Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)
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

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline PatGA-Genital score >= 2.

Arm/Group Title	Placebo	Ixekizumab 80mg Q2W
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 was by given subcutaneous injection.	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.
Measure Participants	73	72
Count of Participants [Participants]	11 14.9%	51 68%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	13.95
	Confidence Interval	(2-Sided) 95%; 6.12 to 31.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
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

Outcome Measure Data

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
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 was by given subcutaneous injection.	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.
Measure Participants	71	72
Least Squares Mean (Standard Error) [units on a scale]	0.687 (0.7998)	5.193 (0.7942)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
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

10. Secondary Outcome

Title	Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
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

Outcome Measure Data

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
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 was by given subcutaneous injection.	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.
Measure Participants	71	72
Least Squares Mean (Standard Error) [units on a scale]	2.186 (0.7333)	3.982 (0.7281)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.085
	Comments
	Method	ANCOVA
	Comments
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

11. Secondary Outcome

Title	Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
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

Outcome Measure Data

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
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 was by given subcutaneous injection.	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.
Measure Participants	66	69
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Total Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Itch
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Pain
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Discomfort
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Stinging
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Burning
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Redness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Scaling
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments	Cracking
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
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

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
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

Outcome Measure Data

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
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 was by given subcutaneous injection.	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.
Measure Participants	73	75
TE-ADA positive	5 6.8%
TE-ADA negative	6 8.1%	50 66.7%
NAb inconclusive	5 6.8%

Adverse Events

Time Frame	Up to 667 Days
Adverse Event Reporting Description	Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Arm/Group Title	Placebo - Blinded Treatment Period		Ixekizumab 80 mg Q2W - Blinded Treatment Period		Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period		Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment		Placebo - Post Treatment Follow-up		Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period		Ixekizumab 80mg Q4W - Post Treatment Follow-up
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 was given by subcutaneous injection during blinded treatment period.		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.		Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.		Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.		Participants did not receive any study treatment during post treatment follow-up period.		Participants did not receive any study treatment during post treatment follow-up period.		Participants did not receive any study treatment during post treatment follow-up period.
All Cause Mortality
	Placebo - Blinded Treatment Period		Ixekizumab 80 mg Q2W - Blinded Treatment Period		Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period		Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment		Placebo - Post Treatment Follow-up		Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period		Ixekizumab 80mg Q4W - 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	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/75 (0%)		0/65 (0%)		0/74 (0%)		0/1 (0%)		0/49 (0%)		0/78 (0%)
Serious Adverse Events
	Placebo - Blinded Treatment Period		Ixekizumab 80 mg Q2W - Blinded Treatment Period		Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period		Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment		Placebo - Post Treatment Follow-up		Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period		Ixekizumab 80mg Q4W - 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	Affected / at Risk (%)	# Events
Total	1/74 (1.4%)		0/75 (0%)		2/65 (3.1%)		5/74 (6.8%)		0/1 (0%)		2/49 (4.1%)		1/78 (1.3%)
Gastrointestinal disorders
Colitis	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	1/74 (1.4%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Pancreatitis acute	1/74 (1.4%)	1	0/75 (0%)	0	0/65 (0%)	0	0/74 (0%)	0	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	1/74 (1.4%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Infections and infestations
Appendicitis	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	0/74 (0%)	0	0/1 (0%)	0	1/49 (2%)	1	0/78 (0%)	0
Cellulitis	0/74 (0%)	0	0/75 (0%)	0	1/65 (1.5%)	1	0/74 (0%)	0	0/1 (0%)	0	1/49 (2%)	1	0/78 (0%)	0
Escherichia bacteraemia	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	1/74 (1.4%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Sepsis	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	1/74 (1.4%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Injury, poisoning and procedural complications
Extradural haematoma	0/74 (0%)	0	0/75 (0%)	0	1/65 (1.5%)	1	0/74 (0%)	0	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Psychiatric disorders
Depression	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	0/74 (0%)	0	0/1 (0%)	0	0/49 (0%)	0	1/78 (1.3%)	1
Suicide attempt	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	1/74 (1.4%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Renal and urinary disorders
Ureterolithiasis	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	1/74 (1.4%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/74 (0%)	0	0/75 (0%)	0	0/49 (0%)	0	1/56 (1.8%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Vascular disorders
Peripheral ischaemia	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	1/74 (1.4%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo - Blinded Treatment Period		Ixekizumab 80 mg Q2W - Blinded Treatment Period		Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period		Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment		Placebo - Post Treatment Follow-up		Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period		Ixekizumab 80mg Q4W - 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	Affected / at Risk (%)	# Events
Total	19/74 (25.7%)		21/75 (28%)		28/65 (43.1%)		27/74 (36.5%)		0/1 (0%)		1/49 (2%)		0/78 (0%)
Gastrointestinal disorders
Diarrhoea	4/74 (5.4%)	4	1/75 (1.3%)	2	0/65 (0%)	0	0/74 (0%)	0	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
General disorders
Injection site reaction	0/74 (0%)	0	5/75 (6.7%)	7	10/65 (15.4%)	24	3/74 (4.1%)	6	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Infections and infestations
Bacterial vaginosis	0/74 (0%)	0	0/75 (0%)	0	0/16 (0%)	0	1/18 (5.6%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Nasopharyngitis	4/74 (5.4%)	4	2/75 (2.7%)	2	9/65 (13.8%)	13	7/74 (9.5%)	8	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Upper respiratory tract infection	5/74 (6.8%)	5	12/75 (16%)	12	10/65 (15.4%)	12	6/74 (8.1%)	6	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Urinary tract infection	0/74 (0%)	0	0/75 (0%)	0	2/65 (3.1%)	2	4/74 (5.4%)	4	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Vulvovaginal candidiasis	0/74 (0%)	0	0/75 (0%)	0	1/16 (6.3%)	2	0/18 (0%)	0	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Vulvovaginal mycotic infection	0/74 (0%)	0	0/75 (0%)	0	0/16 (0%)	0	1/18 (5.6%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	5/74 (6.8%)	5	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Nervous system disorders
Headache	4/74 (5.4%)	6	3/75 (4%)	3	2/65 (3.1%)	2	6/74 (8.1%)	6	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/74 (0%)	0	0/75 (0%)	0	0/16 (0%)	0	1/18 (5.6%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Vaginal haemorrhage	0/74 (0%)	0	0/75 (0%)	0	0/16 (0%)	0	1/18 (5.6%)	1	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0
Vulvovaginal discomfort	0/74 (0%)	0	0/75 (0%)	0	0/65 (0%)	0	0/74 (0%)	0	0/0 (NaN)	0	1/11 (9.1%)	1	0/21 (0%)	0
Skin and subcutaneous tissue disorders
Psoriasis	4/74 (5.4%)	4	1/75 (1.3%)	1	0/65 (0%)	0	0/74 (0%)	0	0/1 (0%)	0	0/49 (0%)	0	0/78 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Disclosures are prohibited until after the sponsor discloses the primary and secondary publications of clinical trial data.