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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03364309
• Collaborator: (none)
• Enrollment: 438
• Locations: 17
• Arms: 3
• Actual Duration (Months): 25.3
• Patients Per Site: 25.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.

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

Detailed Description

Study I1F-MC-RHBH is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis (Ps) during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, 48-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse or rebound following treatment withdrawal, and response to retreatment following relapse.

Study Design

• Study Type: Interventional
• Actual Enrollment: 438 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
• Actual Study Start Date: Apr 26, 2018
• Actual Primary Completion Date: Jun 4, 2020
• Actual Study Completion Date: Jun 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ixekizumab 80mg Q4W Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821
Experimental: Ixekizumab 80mg Q2W Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821 ; Drug: Placebo; Administered SC
Placebo Comparator: Placebo Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement [Week 12]

   The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

2. Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [Week 12]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Secondary Outcome Measures

1. Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission) [Week 12]

   The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.

2. Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) [Week 12]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

3. Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [Week 12]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

4. Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4 [Week 12]

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

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

   The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life. Least Square Mean (LS Mean) was calculated using Mixed Model Repeated Measures (MMRM) model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

6. Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement [Baseline, Week 12]

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

7. Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis [Baseline, Week 12]

   The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

8. Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement [Baseline, Week 12]

   The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

9. Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score [Baseline, Week 12]

   The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

10. Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score [Baseline, Week 12]

    The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

11. Change From Baseline on Patient Global Assessment of Disease Severity [Baseline, Week 12]

    The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

12. Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement [Baseline, Week 12]

    The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

13. Change From Baseline on the Joint Pain Visual Analog Scale (VAS) [Baseline, Week 12]

    The Joint Pain VAS is a participant-administered scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of a participant's joint pain from PsA is indicated by placing a single mark on the horizontal scale (0 = none; 100 = as severe as you can imagine). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

14. Percentage of Participants With Anti-Ixekizumab Antibodies [Baseline through Week 12]

    Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline.

• Have ≥10% BSA involvement at screening and baseline.

• Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.

• Are candidates for phototherapy and/or systemic therapy.

Exclusion Criteria:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.

• Drug-induced psoriasis.

• Ongoing use of prohibited treatments.

• Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor.

• Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to baseline, whichever is longer.

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing	Beijing	China	100044
2	Peking University Third Hospital	Beijing	Beijing	China	100191
3	Guangdong Province People's Hospital	Guangzhou	Guangdong	China	510080
4	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410011
5	YanCheng First People's Hospital	Yancheng	Jiangsu	China	224005
6	The Second Hospital of Jilin University	Changchun	Jilin	China	130022
7	The First Hospital of China Medical University	Shenyang	Liaoning	China	110001
8	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Nanjing	China	210029
9	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710004
10	First Hospital of Shanxi Medical University	Taiyuan	Shan XI	China	030001
11	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041
12	Second Affiliate Hospital of Zhejiang Medical University	Hangzhou	Zhejiang	China	310009
13	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310014
14	Beijing Chao Yang Hospital	Beijing		China	100020
15	Peking University First Hospital	Beijing		China	100034
16	Ruijin Hospital Affiliated to Shanghai Jiao Tong University	Shanghai		China	200025
17	Shanghai Dermatology Hospital	Shanghai		China	200443

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 - Jun 14, 2019
• Statistical Analysis Plan - Jul 27, 2020

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03364309
• Other Study ID Numbers: 14438; I1F-MC-RHBH
• First Posted: Dec 6, 2017
• Last Update Posted: Jun 25, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Eli Lilly and Company: plaque psoriasis; ixekizumab; skin condition; skin disease; itching; psoriasis vulgaris; immune-mediated systemic disease; skin lesions; scaly patches; papules
• Additional relevant MeSH terms: Psoriasis; Ixekizumab

Study Results

Participant Flow

Recruitment Details

Responders were defined as achieving an sPGA score of 0 or 1. Non-responders were defined as having an sPGA score of >1. Responders were monitored for relapse, relapse (loss of response) occurring after Week 12 (Visit 7) was defined as an sPGA score of ≥3. In Re-treatment (Maintenance) Period, participants who relapsed received continued treatment of ixekizumab 80 mg Q4W, regardless of their treatment assignment.

Pre-assignment Detail

Induction Dosing Period: Week 0 (baseline) to Week 12. Maintenance Dosing Period and Re-treatment (Maintenance) Period: Week 12 to Week 60. Post-Treatment Follow-Up Period: Occurred from last treatment period visit or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.

Arm/Group Title	PBO-Induction Dosing Period	IXE80Q4W-Induction Dosing Period	IXE80Q2W-Induction Dosing Period	IXE80Q4W(Res)/PBO-Maintenance Dosing Period	IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period	IXE80Q2W(Res)/PBO-Maintenance Dosing Period	IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period	PBO(Res)/PBO-Maintenance Dosing Period	PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period	IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period	IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period	PBO(Resp)/PBO-Re-treatment (Maintenance) Period	IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period	IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period	IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period	IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period	PBO-Follow-up Period	IXE80Q4W-Follow-up Period	IXE80Q2W-Follow-up Period
Arm/Group Description	Participants received placebo (PBO) every two weeks (Q2W) by subcutaneous (SC) injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab (IXE) at week 0 followed by 80mg Ixekizumab once every four weeks (80Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (80Q2W) by subcutaneous injection during induction period	Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.	Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.	Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.	Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.	Participants who received placebo in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.	Participants who received placebo in induction period and classified as Non-responders (NonResp) received Ixekizumab 80 mg Q4W by SC injection in maintenance dosing period.	Participants who received Ixekizumab 80mg Q4W in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.	Participants who received Ixekizumab 80mg Q2W in induction period and classified as non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.	Participants who were classified as placebo responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.	Participants who were classified as Ixekizumab 80mg Q4W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.	Participants who were classified as Ixekizumab 80mg Q4W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.	Participants who were classified as Ixekizumab 80mg Q2W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.	Participants who were classified as Ixekizumab 80mg Q2W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.	Participants did not receive any intervention in post treatment follow-up period	Participants did not receive any intervention in post treatment follow-up period	Participants did not receive any intervention in post treatment follow-up period
Period Title: Induction Period
STARTED	88	174	176	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Received at Least One Dose of Study Drug	88	174	176	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	82	170	175	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	6	4	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Induction Period
STARTED	0	0	0	47	92	50	100	3	79	31	23	0	0	0	0	0	0	0	0
Received at Least One Dose of Study Drug	0	0	0	47	92	50	100	3	79	31	23	0	0	0	0	0	0	0	0
COMPLETED	0	0	0	3	80	4	84	1	73	27	17	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	44	12	46	16	2	6	4	6	0	0	0	0	0	0	0	0
Period Title: Induction Period
STARTED	0	0	0	0	0	0	0	0	0	0	0	2	43	7	45	10	0	0	0
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	2	42	6	43	8	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	1	1	2	2	0	0	0
Period Title: Induction Period
STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	11	375	2
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	344	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	31	2

Baseline Characteristics

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W	Total
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period	Total of all reporting groups
Overall Participants	88	174	176	438
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.9 (12.38)	41.2 (11.59)	39.2 (10.53)	40.5 (11.37)
Sex: Female, Male (Count of Participants)
Female	24 27.3%	45 25.9%	34 19.3%	103 23.5%
Male	64 72.7%	129 74.1%	142 80.7%	335 76.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	88 100%	174 100%	176 100%	438 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
China	88 100%	174 100%	176 100%	438 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Description	The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	88	174	176
Number (95% Confidence Interval) [Percentage of participants]	3.4 3.9%	79.9 45.9%	86.4 49.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	99.99
	Confidence Interval	(2-Sided) 95%; 33.57 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

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	99.99
	Confidence Interval	(2-Sided) 95%; 52.49 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	88	174	176
Number (95% Confidence Interval) [Percentage of participants]	8.0 9.1%	87.4 50.2%	93.8 53.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	79.95
	Confidence Interval	(2-Sided) 95%; 32.76 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

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	99.99
	Confidence Interval	(2-Sided) 95%; 64.87 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)
Description	The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for sPGA (0). Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	88	174	176
Number (95% Confidence Interval) [Percentage of participants]	0.0 0%	35.6 20.5%	36.4 20.7%

4. Secondary Outcome

Title	Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	88	174	176
Number (95% Confidence Interval) [Percentage of participants]	2.3 2.6%	75.9 43.6%	82.4 46.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	99.99
	Confidence Interval	(2-Sided) 95%; 31.88 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

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	99.99
	Confidence Interval	(2-Sided) 95%; 46.96 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	88	174	176
Number (95% Confidence Interval) [Percentage of participants]	0.0 0%	29.3 16.8%	33.0 18.8%

6. Secondary Outcome

Title	Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4
Description	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline who had baseline Itch NRS ≥4.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	62	128	125
Number (95% Confidence Interval) [percentage of participants]	8.1 9.2%	76.6 44%	78.4 44.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	37.24
	Confidence Interval	(2-Sided) 95%; 13.68 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

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	41.38
	Confidence Interval	(2-Sided) 95%; 15.09 to 99.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Description	The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life. Least Square Mean (LS Mean) was calculated using Mixed Model Repeated Measures (MMRM) model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline DLQI total score.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	82	170	175
Least Squares Mean (Standard Error) [units on a scale]	0.92 (0.495)	-8.60 (0.346)	-8.86 (0.343)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	LSMean Difference
	Estimated Value	-9.52
	Confidence Interval	(2-Sided) 95%; -10.71 to -8.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.604
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	-9.78
	Confidence Interval	(2-Sided) 95%; -10.96 to -8.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.603
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement
Description	NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline fingernail involvement.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	66	132	130
Least Squares Mean (Standard Error) [units on a scale]	-1.26 (1.365)	-11.35 (0.967)	-10.07 (0.974)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	LSMean Difference
	Estimated Value	-10.09
	Confidence Interval	(2-Sided) 95%; -13.38 to -6.79
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.673
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	-8.81
	Confidence Interval	(2-Sided) 95%; -12.11 to -5.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.677
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis
Description	The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had postbaseline BSA involvement.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	82	170	175
Least Squares Mean (Standard Error) [Percent of BSA]	-0.36 (1.660)	-35.32 (1.157)	-36.70 (1.146)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	LSMean Difference
	Estimated Value	-34.96
	Confidence Interval	(2-Sided) 95%; -38.94 to -30.98
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.023
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	-36.34
	Confidence Interval	(2-Sided) 95%; -40.30 to -32.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.018
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement
Description	The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline scalp involvement.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	78	166	171
Least Squares Mean (Standard Error) [units on a scale]	-1.59 (0.787)	-18.33 (0.544)	-19.52 (0.539)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	LSMean Difference
	Estimated Value	-16.74
	Confidence Interval	(2-Sided) 95%; -18.62 to -14.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.957
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	-17.93
	Confidence Interval	(2-Sided) 95%; -19.80 to -16.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.954
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Description	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had post baseline SF-36 PCS score.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	82	170	175
Least Squares Mean (Standard Error) [units on a scale]	-1.812 (0.5492)	4.417 (0.3815)	4.724 (0.3766)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	LSMean Difference
	Estimated Value	6.228
	Confidence Interval	(2-Sided) 95%; 4.915 to 7.541
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6681
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	6.536
	Confidence Interval	(2-Sided) 95%; 5.225 to 7.847
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6668
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score
Description	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had post baseline SF-36 MCS score.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	82	170	175
Least Squares Mean (Standard Error) [units on a scale]	-1.233 (0.7798)	3.960 (0.5414)	4.129 (0.5342)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	LSMean Difference
	Estimated Value	5.193
	Confidence Interval	(2-Sided) 95%; 3.328 to 7.058
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9489
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	5.362
	Confidence Interval	(2-Sided) 95%; 3.503 to 7.222
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9460
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline on Patient Global Assessment of Disease Severity
Description	The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had postbaseline patient global assessment score.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	82	170	175
Least Squares Mean (Standard Error) [units on a scale]	-0.5 (0.12)	-3.1 (0.08)	-3.1 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	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	LSMean Difference
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -2.9 to -2.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -2.9 to -2.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement
Description	The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline palmoplantar psoriasis involvement.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	26	41	51
Least Squares Mean (Standard Error) [units on a scale]	-2.99 (0.861)	-6.34 (0.688)	-7.78 (0.626)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	-3.35
	Confidence Interval	(2-Sided) 95%; -5.56 to -1.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.110
	Estimation Comments

Statistical Analysis 2

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	LSMean Difference
	Estimated Value	-4.79
	Confidence Interval	(2-Sided) 95%; -6.90 to -2.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.064
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline on the Joint Pain Visual Analog Scale (VAS)
Description	The Joint Pain VAS is a participant-administered scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of a participant's joint pain from PsA is indicated by placing a single mark on the horizontal scale (0 = none; 100 = as severe as you can imagine). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline psoriatic arthritis.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	3	8	12
Least Squares Mean (Standard Error) [millimeter (mm)]	-12.2 (9.64)	-39.6 (5.48)	-37.4 (4.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q4W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	-27.4
	Confidence Interval	(2-Sided) 95%; -50.5 to -4.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 11.07
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab 80mg Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.031
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	-25.2
	Confidence Interval	(2-Sided) 95%; -47.8 to -2.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 10.87
	Estimation Comments

16. Secondary Outcome

Title	Percentage of Participants With Anti-Ixekizumab Antibodies
Description	Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	Placebo	Ixekizumab 80mg Q4W	Ixekizumab 80mg Q2W
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Measure Participants	88	174	176
Number [percentage of participants]	0 0%	19 10.9%	12.5 7.1%

Adverse Events

Time Frame	Up to 72 weeks
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Arm/Group Title	PBO-Induction Dosing Period		IXE80Q4W-Induction Dosing Period		IXE80Q2W-Induction Dosing Period		IXE80Q4W(Res)/PBO-Maintenance Dosing Period		IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(Res)/PBO-Maintenance Dosing Period		IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period		PBO(Res)/PBO-Maintenance Dosing Period		PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period		PBO(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		PBO-Follow-up Period		IXE80Q4W-Follow-up Period		IXE80Q2W-Follow-up Period
Arm/Group Description	Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.		Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period		Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period		Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.		Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.		Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.		Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.		Participants who received placebo in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.		Participants who received placebo in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.		Participants who received Ixekizumab 80mg Q4W in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.		Participants who received Ixekizumab 80mg Q2W in induction period and classified as non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.		Participants who were classified as placebo responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.		Participants who were classified as Ixekizumab 80mg Q4W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.		Participants who were classified as Ixekizumab 80mg Q4W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.		Participants who were classified as Ixekizumab 80mg Q2W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.		Participants who were classified as Ixekizumab 80mg Q2W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.		Participants did not receive any intervention in post treatment follow-up period		Participants did not receive any intervention in post treatment follow-up period		Participants did not receive any intervention in post treatment follow-up period
All Cause Mortality
	PBO-Induction Dosing Period		IXE80Q4W-Induction Dosing Period		IXE80Q2W-Induction Dosing Period		IXE80Q4W(Res)/PBO-Maintenance Dosing Period		IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(Res)/PBO-Maintenance Dosing Period		IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period		PBO(Res)/PBO-Maintenance Dosing Period		PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period		PBO(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		PBO-Follow-up Period		IXE80Q4W-Follow-up Period		IXE80Q2W-Follow-up Period
	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	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	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/88 (0%)		0/174 (0%)		0/176 (0%)		0/47 (0%)		0/92 (0%)		0/50 (0%)		0/100 (0%)		0/3 (0%)		1/79 (1.3%)		0/31 (0%)		0/23 (0%)		0/2 (0%)		0/43 (0%)		0/7 (0%)		0/45 (0%)		0/10 (0%)		0/11 (0%)		0/375 (0%)		0/2 (0%)
Serious Adverse Events
	PBO-Induction Dosing Period		IXE80Q4W-Induction Dosing Period		IXE80Q2W-Induction Dosing Period		IXE80Q4W(Res)/PBO-Maintenance Dosing Period		IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(Res)/PBO-Maintenance Dosing Period		IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period		PBO(Res)/PBO-Maintenance Dosing Period		PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period		PBO(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		PBO-Follow-up Period		IXE80Q4W-Follow-up Period		IXE80Q2W-Follow-up Period
	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	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	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/88 (3.4%)		2/174 (1.1%)		1/176 (0.6%)		1/47 (2.1%)		5/92 (5.4%)		1/50 (2%)		2/100 (2%)		1/3 (33.3%)		5/79 (6.3%)		0/31 (0%)		1/23 (4.3%)		0/2 (0%)		1/43 (2.3%)		0/7 (0%)		2/45 (4.4%)		0/10 (0%)		0/11 (0%)		7/375 (1.9%)		0/2 (0%)
Cardiac disorders
Arteriosclerosis coronary artery	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Gastrointestinal disorders
Anal fistula	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	1/92 (1.1%)	1	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Gastric ulcer	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Hepatobiliary disorders
Bile duct stone	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Cholangitis	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Hepatic function abnormal	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Infections and infestations
Anal abscess	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Appendicitis	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Chronic tonsillitis	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	1/92 (1.1%)	1	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Infection	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	1/50 (2%)	1	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Pneumonia	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	1/92 (1.1%)	1	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	1/23 (4.3%)	1	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Injury	0/88 (0%)	0	1/174 (0.6%)	1	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Multiple fractures	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Metabolism and nutrition disorders
Hyperglycaemia	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Type 2 diabetes mellitus	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	1/47 (2.1%)	1	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Jaw cyst	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	1/50 (2%)	1	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Osteonecrosis	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	1/100 (1%)	1	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Eyelid naevus	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	1/92 (1.1%)	1	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Invasive ductal breast carcinoma	0/88 (0%)	0	0/174 (0%)	0	1/176 (0.6%)	1	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Nervous system disorders
Cerebral infarction	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	1/100 (1%)	2	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Generalised tonic-clonic seizure	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy	0/24 (0%)	0	0/45 (0%)	0	0/34 (0%)	0	0/10 (0%)	0	1/27 (3.7%)	1	0/14 (0%)	0	0/15 (0%)	0	0/1 (0%)	0	0/21 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	0/10 (0%)	0	0/3 (0%)	0	0/12 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/84 (0%)	0	0/1 (0%)	0
Renal and urinary disorders
Ureterolithiasis	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Reproductive system and breast disorders
Hydrosalpinx	0/24 (0%)	0	0/45 (0%)	0	0/34 (0%)	0	0/10 (0%)	0	0/27 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/1 (100%)	1	0/21 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	0/1 (0%)	0	0/10 (0%)	0	0/3 (0%)	0	0/12 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/84 (0%)	0	0/1 (0%)	0
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis	2/88 (2.3%)	2	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Psoriasis	1/88 (1.1%)	1	1/174 (0.6%)	1	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Pustular psoriasis	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Vascular disorders
Hypertension	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	1/47 (2.1%)	1	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Shock haemorrhagic	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	PBO-Induction Dosing Period		IXE80Q4W-Induction Dosing Period		IXE80Q2W-Induction Dosing Period		IXE80Q4W(Res)/PBO-Maintenance Dosing Period		IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(Res)/PBO-Maintenance Dosing Period		IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period		PBO(Res)/PBO-Maintenance Dosing Period		PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period		IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period		PBO(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period		IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period		PBO-Follow-up Period		IXE80Q4W-Follow-up Period		IXE80Q2W-Follow-up Period
	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	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	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/88 (28.4%)		89/174 (51.1%)		97/176 (55.1%)		24/47 (51.1%)		68/92 (73.9%)		22/50 (44%)		66/100 (66%)		1/3 (33.3%)		58/79 (73.4%)		22/31 (71%)		14/23 (60.9%)		1/2 (50%)		24/43 (55.8%)		4/7 (57.1%)		27/45 (60%)		5/10 (50%)		0/11 (0%)		27/375 (7.2%)		0/2 (0%)
Blood and lymphatic system disorders
Neutropenia	0/88 (0%)	0	0/174 (0%)	0	2/176 (1.1%)	2	0/47 (0%)	0	3/92 (3.3%)	3	1/50 (2%)	1	1/100 (1%)	1	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	1	1/7 (14.3%)	2	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Eye disorders
Vitreous opacities	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	1/3 (33.3%)	1	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
General disorders
Injection site hypersensitivity	0/88 (0%)	0	0/174 (0%)	0	1/176 (0.6%)	1	0/47 (0%)	0	2/92 (2.2%)	4	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	2/31 (6.5%)	2	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Injection site reaction	0/88 (0%)	0	13/174 (7.5%)	18	19/176 (10.8%)	43	0/47 (0%)	0	17/92 (18.5%)	62	0/50 (0%)	0	17/100 (17%)	64	0/3 (0%)	0	8/79 (10.1%)	40	3/31 (9.7%)	6	2/23 (8.7%)	12	0/2 (0%)	0	3/43 (7%)	5	1/7 (14.3%)	2	5/45 (11.1%)	20	1/10 (10%)	10	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Injection site swelling	0/88 (0%)	0	0/174 (0%)	0	3/176 (1.7%)	3	0/47 (0%)	0	1/92 (1.1%)	4	0/50 (0%)	0	3/100 (3%)	19	0/3 (0%)	0	2/79 (2.5%)	6	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	6	1/7 (14.3%)	5	2/45 (4.4%)	13	1/10 (10%)	1	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Soft tissue inflammation	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Hepatobiliary disorders
Hepatic function abnormal	2/88 (2.3%)	2	10/174 (5.7%)	10	4/176 (2.3%)	4	0/47 (0%)	0	1/92 (1.1%)	1	2/50 (4%)	2	5/100 (5%)	5	0/3 (0%)	0	4/79 (5.1%)	5	3/31 (9.7%)	3	3/23 (13%)	3	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	2/45 (4.4%)	2	0/10 (0%)	0	0/11 (0%)	0	5/375 (1.3%)	5	0/2 (0%)	0
Infections and infestations
Folliculitis	0/88 (0%)	0	4/174 (2.3%)	4	3/176 (1.7%)	3	0/47 (0%)	0	3/92 (3.3%)	3	1/50 (2%)	1	6/100 (6%)	7	0/3 (0%)	0	4/79 (5.1%)	4	2/31 (6.5%)	5	3/23 (13%)	4	0/2 (0%)	0	2/43 (4.7%)	2	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Nasopharyngitis	0/88 (0%)	0	4/174 (2.3%)	5	8/176 (4.5%)	10	2/47 (4.3%)	3	6/92 (6.5%)	7	2/50 (4%)	4	4/100 (4%)	4	0/3 (0%)	0	3/79 (3.8%)	6	1/31 (3.2%)	1	3/23 (13%)	4	0/2 (0%)	0	2/43 (4.7%)	2	1/7 (14.3%)	1	2/45 (4.4%)	2	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Pharyngitis	2/88 (2.3%)	2	5/174 (2.9%)	7	4/176 (2.3%)	4	0/47 (0%)	0	5/92 (5.4%)	5	1/50 (2%)	1	6/100 (6%)	6	0/3 (0%)	0	9/79 (11.4%)	9	0/31 (0%)	0	3/23 (13%)	3	1/2 (50%)	1	1/43 (2.3%)	1	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Rhinitis	1/88 (1.1%)	1	1/174 (0.6%)	1	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	3/43 (7%)	4	0/7 (0%)	0	1/45 (2.2%)	2	1/10 (10%)	1	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Skin infection	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	1/7 (14.3%)	1	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Tinea cruris	0/88 (0%)	0	0/174 (0%)	0	1/176 (0.6%)	1	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	2/100 (2%)	2	0/3 (0%)	0	1/79 (1.3%)	1	2/31 (6.5%)	3	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Tinea pedis	0/88 (0%)	0	9/174 (5.2%)	9	9/176 (5.1%)	9	3/47 (6.4%)	3	11/92 (12%)	12	3/50 (6%)	3	10/100 (10%)	11	0/3 (0%)	0	6/79 (7.6%)	11	4/31 (12.9%)	4	2/23 (8.7%)	2	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	2/45 (4.4%)	2	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Tonsillitis	0/88 (0%)	0	2/174 (1.1%)	2	2/176 (1.1%)	2	0/47 (0%)	0	0/92 (0%)	0	1/50 (2%)	1	2/100 (2%)	2	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	2/7 (28.6%)	2	1/45 (2.2%)	2	1/10 (10%)	1	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Upper respiratory tract infection	9/88 (10.2%)	10	25/174 (14.4%)	27	28/176 (15.9%)	34	7/47 (14.9%)	8	25/92 (27.2%)	35	6/50 (12%)	6	31/100 (31%)	42	0/3 (0%)	0	22/79 (27.8%)	24	8/31 (25.8%)	12	3/23 (13%)	4	1/2 (50%)	1	7/43 (16.3%)	8	2/7 (28.6%)	2	9/45 (20%)	11	0/10 (0%)	0	0/11 (0%)	0	4/375 (1.1%)	4	0/2 (0%)	0
Investigations
Blood glucose decreased	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	1/3 (33.3%)	1	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Blood glucose increased	2/88 (2.3%)	4	4/174 (2.3%)	4	3/176 (1.7%)	3	2/47 (4.3%)	2	3/92 (3.3%)	4	0/50 (0%)	0	2/100 (2%)	2	0/3 (0%)	0	5/79 (6.3%)	5	2/31 (6.5%)	3	4/23 (17.4%)	4	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	4/45 (8.9%)	4	0/10 (0%)	0	0/11 (0%)	0	4/375 (1.1%)	4	0/2 (0%)	0
Blood immunoglobulin a increased	0/88 (0%)	0	0/174 (0%)	0	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	2/100 (2%)	2	0/3 (0%)	0	1/79 (1.3%)	1	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Blood triglycerides increased	1/88 (1.1%)	1	5/174 (2.9%)	5	2/176 (1.1%)	2	0/47 (0%)	0	1/92 (1.1%)	1	4/50 (8%)	5	2/100 (2%)	2	0/3 (0%)	0	0/79 (0%)	0	3/31 (9.7%)	4	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Blood uric acid increased	2/88 (2.3%)	3	1/174 (0.6%)	1	0/176 (0%)	0	1/47 (2.1%)	1	5/92 (5.4%)	5	0/50 (0%)	0	2/100 (2%)	2	0/3 (0%)	0	1/79 (1.3%)	2	3/31 (9.7%)	4	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	3/375 (0.8%)	3	0/2 (0%)	0
Blood urine present	0/88 (0%)	0	2/174 (1.1%)	2	1/176 (0.6%)	1	1/47 (2.1%)	1	1/92 (1.1%)	1	0/50 (0%)	0	1/100 (1%)	1	0/3 (0%)	0	5/79 (6.3%)	5	4/31 (12.9%)	4	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	0/45 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Lymphocyte count abnormal	0/88 (0%)	0	2/174 (1.1%)	2	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	1/31 (3.2%)	1	2/23 (8.7%)	2	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Protein urine present	1/88 (1.1%)	1	3/174 (1.7%)	3	5/176 (2.8%)	5	2/47 (4.3%)	2	4/92 (4.3%)	4	0/50 (0%)	0	1/100 (1%)	1	0/3 (0%)	0	3/79 (3.8%)	3	2/31 (6.5%)	2	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Urine ketone body present	0/88 (0%)	0	0/174 (0%)	0	2/176 (1.1%)	2	0/47 (0%)	0	1/92 (1.1%)	1	0/50 (0%)	0	1/100 (1%)	1	0/3 (0%)	0	1/79 (1.3%)	1	2/31 (6.5%)	2	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Urine leukocyte esterase positive	0/88 (0%)	0	0/174 (0%)	0	1/176 (0.6%)	1	0/47 (0%)	0	1/92 (1.1%)	1	0/50 (0%)	0	1/100 (1%)	1	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	0/45 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Metabolism and nutrition disorders
Hyperlipidaemia	1/88 (1.1%)	1	6/174 (3.4%)	6	3/176 (1.7%)	3	2/47 (4.3%)	2	4/92 (4.3%)	4	0/50 (0%)	0	3/100 (3%)	4	0/3 (0%)	0	6/79 (7.6%)	6	1/31 (3.2%)	1	3/23 (13%)	3	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	2/375 (0.5%)	2	0/2 (0%)	0
Hyperuricaemia	1/88 (1.1%)	1	3/174 (1.7%)	3	3/176 (1.7%)	4	1/47 (2.1%)	1	5/92 (5.4%)	7	1/50 (2%)	1	5/100 (5%)	6	0/3 (0%)	0	3/79 (3.8%)	5	1/31 (3.2%)	1	2/23 (8.7%)	2	0/2 (0%)	0	2/43 (4.7%)	2	1/7 (14.3%)	1	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/88 (2.3%)	2	4/174 (2.3%)	5	2/176 (1.1%)	2	2/47 (4.3%)	2	2/92 (2.2%)	2	2/50 (4%)	3	4/100 (4%)	4	0/3 (0%)	0	0/79 (0%)	0	1/31 (3.2%)	1	2/23 (8.7%)	2	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	3/375 (0.8%)	3	0/2 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/88 (0%)	0	4/174 (2.3%)	4	3/176 (1.7%)	4	0/47 (0%)	0	8/92 (8.7%)	9	2/50 (4%)	3	5/100 (5%)	5	0/3 (0%)	0	2/79 (2.5%)	2	1/31 (3.2%)	1	2/23 (8.7%)	2	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	2/45 (4.4%)	2	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Oropharyngeal pain	1/88 (1.1%)	1	6/174 (3.4%)	6	5/176 (2.8%)	5	4/47 (8.5%)	8	2/92 (2.2%)	2	5/50 (10%)	6	4/100 (4%)	4	0/3 (0%)	0	2/79 (2.5%)	2	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	5/45 (11.1%)	6	0/10 (0%)	0	0/11 (0%)	0	1/375 (0.3%)	1	0/2 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/88 (0%)	0	1/174 (0.6%)	1	0/176 (0%)	0	0/47 (0%)	0	0/92 (0%)	0	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	0/79 (0%)	0	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	0/45 (0%)	0	1/10 (10%)	1	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Dermatitis allergic	0/88 (0%)	0	2/174 (1.1%)	2	1/176 (0.6%)	1	0/47 (0%)	0	1/92 (1.1%)	1	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	4/79 (5.1%)	4	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	0/43 (0%)	0	1/7 (14.3%)	1	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Eczema	0/88 (0%)	0	1/174 (0.6%)	1	4/176 (2.3%)	5	1/47 (2.1%)	2	8/92 (8.7%)	8	0/50 (0%)	0	6/100 (6%)	8	0/3 (0%)	0	1/79 (1.3%)	1	2/31 (6.5%)	2	1/23 (4.3%)	1	0/2 (0%)	0	2/43 (4.7%)	2	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	2/375 (0.5%)	2	0/2 (0%)	0
Pruritus	2/88 (2.3%)	2	8/174 (4.6%)	11	8/176 (4.5%)	9	4/47 (8.5%)	4	0/92 (0%)	0	0/50 (0%)	0	1/100 (1%)	1	0/3 (0%)	0	2/79 (2.5%)	3	0/31 (0%)	0	1/23 (4.3%)	1	0/2 (0%)	0	0/43 (0%)	0	0/7 (0%)	0	1/45 (2.2%)	1	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Urticaria	1/88 (1.1%)	1	5/174 (2.9%)	7	10/176 (5.7%)	10	1/47 (2.1%)	1	4/92 (4.3%)	5	0/50 (0%)	0	7/100 (7%)	10	0/3 (0%)	0	9/79 (11.4%)	12	2/31 (6.5%)	2	1/23 (4.3%)	1	0/2 (0%)	0	3/43 (7%)	3	0/7 (0%)	0	4/45 (8.9%)	5	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0
Vascular disorders
Hypertension	3/88 (3.4%)	3	5/174 (2.9%)	5	4/176 (2.3%)	4	1/47 (2.1%)	1	3/92 (3.3%)	3	0/50 (0%)	0	0/100 (0%)	0	0/3 (0%)	0	4/79 (5.1%)	4	0/31 (0%)	0	0/23 (0%)	0	0/2 (0%)	0	1/43 (2.3%)	1	0/7 (0%)	0	0/45 (0%)	0	0/10 (0%)	0	0/11 (0%)	0	0/375 (0%)	0	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.