Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (NCT NCT02718898)

Last Updated: 2019-09-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

149 participants

Primary outcome timeframe

Week 12

Results posted on

2019-09-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Placebo - Blinded Treatment 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.	Ixekizumab 80mg Q2W - Blinded Treatment 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.	Placebo/Ixekizumab 80mg Q4W - Open Label 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.	Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment 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.	Placebo - Post Treatment Follow-up Participants did not receive any study treatment during post treatment follow-up period.	Ixeqizumab 80mg Q4W - Post Treatment Follow-up Period Participants did not receive any study treatment during post treatment follow-up period.	Ixekizumab 80mg Q2W - Post Treatment Follow-up Participants did not receive any study treatment during post treatment follow-up period.
Blinded Treatment Period STARTED	74	75	0	0	0	0	0
Blinded Treatment Period COMPLETED	65	74	0	0	0	0	0
Blinded Treatment Period NOT COMPLETED	9	1	0	0	0	0	0
Open Label Treatment Period (OLTP) STARTED	0	0	65	74	0	0	0
Open Label Treatment Period (OLTP) COMPLETED	0	0	62	64	0	0	0
Open Label Treatment Period (OLTP) NOT COMPLETED	0	0	3	10	0	0	0
Post Treatment Follow-up Period STARTED	0	0	0	0	1	78	49
Post Treatment Follow-up Period COMPLETED	0	0	0	0	0	67	44
Post Treatment Follow-up Period NOT COMPLETED	0	0	0	0	1	11	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo - Blinded Treatment 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.	Ixekizumab 80mg Q2W - Blinded Treatment 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.	Placebo/Ixekizumab 80mg Q4W - Open Label 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.	Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment 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.	Placebo - Post Treatment Follow-up Participants did not receive any study treatment during post treatment follow-up period.	Ixeqizumab 80mg Q4W - Post Treatment Follow-up Period Participants did not receive any study treatment during post treatment follow-up period.	Ixekizumab 80mg Q2W - Post Treatment Follow-up Participants did not receive any study treatment during post treatment follow-up period.
Blinded Treatment Period Adverse Event	5	1	0	0	0	0	0
Blinded Treatment Period Physician Decision	1	0	0	0	0	0	0
Blinded Treatment Period Lack of Efficacy	1	0	0	0	0	0	0
Blinded Treatment Period Lost to Follow-up	2	0	0	0	0	0	0
Open Label Treatment Period (OLTP) Adverse Event	0	0	1	1	0	0	0
Open Label Treatment Period (OLTP) Lost to Follow-up	0	0	0	2	0	0	0
Open Label Treatment Period (OLTP) Withdrawal by Subject	0	0	1	3	0	0	0
Open Label Treatment Period (OLTP) Lack of Efficacy	0	0	1	2	0	0	0
Open Label Treatment Period (OLTP) Subject discontinued in OLTP	0	0	0	1	0	0	0
Open Label Treatment Period (OLTP) Ttt of undisclosed addiction-Pt withdrew	0	0	0	1	0	0	0
Post Treatment Follow-up Period Adverse Event	0	0	0	0	0	1	1
Post Treatment Follow-up Period Lost to Follow-up	0	0	0	0	1	5	1
Post Treatment Follow-up Period Withdrawal by Subject	0	0	0	0	0	5	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=74 Participants 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.	Ixekizumab 80mg Q2W n=75 Participants 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 n=149 Participants Total of all reporting groups
Age, Continuous	44.4 years STANDARD_DEVIATION 12.55 • n=5 Participants	43.1 years STANDARD_DEVIATION 12.95 • n=7 Participants	43.7 years STANDARD_DEVIATION 12.72 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	60 Participants n=7 Participants	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	67 Participants n=7 Participants	131 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Puerto Rico	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Austria	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Netherlands	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Turkey	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Belgium	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment Australia	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
sPGA of Genitalia	3.5 units on a scale STANDARD_DEVIATION 0.53 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 0.57 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: All randomized participants.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants 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.	Ixekizumab 80mg Q2W n=75 Participants 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.
Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)	6 Participants	55 Participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants.

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.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants 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.	Ixekizumab 80mg Q2W n=75 Participants 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.
Number of Participants Achieving Overall sPGA (0,1)	2 Participants	55 Participants

SECONDARY outcome

Timeframe: Week 12

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

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).

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants 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.	Ixekizumab 80mg Q2W n=62 Participants 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.
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)	5 Participants	37 Participants

SECONDARY outcome

Timeframe: Week 12

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

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).

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants 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.	Ixekizumab 80mg Q2W n=37 Participants 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.
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	9 Participants	29 Participants

SECONDARY outcome

Timeframe: Week 12

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

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)

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants 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.	Ixekizumab 80mg Q2W n=30 Participants 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.
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)	9 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants 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.	Ixekizumab 80mg Q2W n=74 Participants 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	-1.4 units on a scale Standard Error 0.62	-9.7 units on a scale Standard Error 0.59

SECONDARY outcome

Timeframe: Baseline, Week 12

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants 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.	Ixekizumab 80mg Q2W n=74 Participants 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.
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score	-3.9 units on a scale Standard Error 1.56	-23.9 units on a scale Standard Error 1.48

SECONDARY outcome

Timeframe: Week 12

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

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).

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants 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.	Ixekizumab 80mg Q2W n=72 Participants 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.
Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)	11 Participants	51 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants 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.	Ixekizumab 80mg Q2W n=72 Participants 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.
Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)	0.687 units on a scale Standard Error 0.7998	5.193 units on a scale Standard Error 0.7942

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants 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.	Ixekizumab 80mg Q2W n=72 Participants 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.
Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)	2.186 units on a scale Standard Error 0.7333	3.982 units on a scale Standard Error 0.7281

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants with baseline and post baseline observation for GPSS total or individual item scores.

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.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants 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.	Ixekizumab 80mg Q2W n=69 Participants 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.
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Redness	-0.63 units on a scale Standard Error 0.287	-4.45 units on a scale Standard Error 0.272
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Total Score	-2.82 units on a scale Standard Error 2.190	-31.57 units on a scale Standard Error 2.070
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Itch	-0.21 units on a scale Standard Error 0.290	-4.02 units on a scale Standard Error 0.274
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Pain	-0.34 units on a scale Standard Error 0.294	-3.84 units on a scale Standard Error 0.278
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Discomfort	-0.42 units on a scale Standard Error 0.298	-4.27 units on a scale Standard Error 0.282
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Stinging	-0.51 units on a scale Standard Error 0.298	-3.74 units on a scale Standard Error 0.281
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Burning	-0.53 units on a scale Standard Error 0.289	-3.73 units on a scale Standard Error 0.273
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Scaling	-0.02 units on a scale Standard Error 0.273	-3.80 units on a scale Standard Error 0.259
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items Cracking	-0.19 units on a scale Standard Error 0.280	-3.74 units on a scale Standard Error 0.264

SECONDARY outcome

Timeframe: Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants 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.	Ixekizumab 80mg Q2W n=75 Participants 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.
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 TE-ADA positive	—	5 Participants
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 TE-ADA negative	6 Participants	50 Participants
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 NAb inconclusive	—	5 Participants

Adverse Events

Placebo - Blinded Treatment Period

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Ixekizumab 80 mg Q2W - Blinded Treatment Period

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo - Post Treatment Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Ixekizumab 80mg Q4W - Post Treatment Follow-up

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Blinded Treatment Period n=74 participants at risk 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.	Ixekizumab 80 mg Q2W - Blinded Treatment Period n=75 participants at risk 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.	Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period n=65 participants at risk 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.	Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment n=74 participants at risk 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.	Placebo - Post Treatment Follow-up n=1 participants at risk Participants did not receive any study treatment during post treatment follow-up period.	Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period n=49 participants at risk Participants did not receive any study treatment during post treatment follow-up period.	Ixekizumab 80mg Q4W - Post Treatment Follow-up n=78 participants at risk Participants did not receive any study treatment during post treatment follow-up period.
Gastrointestinal disorders Colitis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatitis acute	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/49 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.5% 1/65 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/49 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Escherichia bacteraemia	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.5% 1/65 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Suicide attempt	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/56 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral ischaemia	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/74 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Placebo - Blinded Treatment Period n=74 participants at risk 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.	Ixekizumab 80 mg Q2W - Blinded Treatment Period n=75 participants at risk 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.	Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period n=65 participants at risk 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.	Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment n=74 participants at risk 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.	Placebo - Post Treatment Follow-up n=1 participants at risk Participants did not receive any study treatment during post treatment follow-up period.	Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period n=49 participants at risk Participants did not receive any study treatment during post treatment follow-up period.	Ixekizumab 80mg Q4W - Post Treatment Follow-up n=78 participants at risk Participants did not receive any study treatment during post treatment follow-up period.
Gastrointestinal disorders Diarrhoea	5.4% 4/74 • Number of events 4 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.3% 1/75 • Number of events 2 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site reaction	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 5/75 • Number of events 7 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 10/65 • Number of events 24 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.1% 3/74 • Number of events 6 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bacterial vaginosis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/16 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	5.4% 4/74 • Number of events 4 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 2/75 • Number of events 2 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.8% 9/65 • Number of events 13 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 7/74 • Number of events 8 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	6.8% 5/74 • Number of events 5 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 12/75 • Number of events 12 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 10/65 • Number of events 12 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.1% 6/74 • Number of events 6 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 2/65 • Number of events 2 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.4% 4/74 • Number of events 4 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 1/16 • Number of events 2 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/16 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.8% 5/74 • Number of events 5 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	5.4% 4/74 • Number of events 6 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 3/75 • Number of events 3 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 2/65 • Number of events 2 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.1% 6/74 • Number of events 6 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/16 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/16 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/75 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	5.4% 4/74 • Number of events 4 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/65 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/74 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/49 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/78 • Up to 667 Days Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Disclosures are prohibited until after the sponsor discloses the primary and secondary publications of clinical trial data.
Publication restrictions are in place

Restriction type: OTHER