IXORA-P: A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02513550
• Collaborator: (none)
• Enrollment: 1,257
• Locations: 125
• Arms: 6
• Duration (Months): 24.1
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

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

Detailed Description

The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Aug 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 80 mg Ixekizumab Q2W 160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52. Placebo administered SQ, Q2W to maintain blind.	Drug: Ixekizumab; Administered SQ; Other Names: LY2439821 ; Drug: Placebo; Administered SQ
Experimental: 80 mg Ixekizumab Q4W 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.	Drug: Ixekizumab; Administered SQ; Other Names: LY2439821 ; Drug: Placebo; Administered SQ
Experimental: 80 mg Ixekizumab Q4W/Q2W 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	Drug: Ixekizumab; Administered SQ; Other Names: LY2439821 ; Drug: Placebo; Administered SQ
Experimental: 80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.	Drug: Ixekizumab; Administered SQ; Other Names: LY2439821 ; Drug: Placebo; Administered SQ
Experimental: 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	Drug: Ixekizumab; Administered SQ; Other Names: LY2439821 ; Drug: Placebo; Administered SQ
Experimental: 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	Drug: Ixekizumab; Administered SQ; Other Names: LY2439821 ; Drug: Placebo; Administered SQ

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) [Week 52]

   The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was 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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.

2. Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) [Week 52]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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 separately 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). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.

Secondary Outcome Measures

1. Percentage of Participants Achieving sPGA (0) [Week 52]

   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. Participant's Ps was 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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.

2. Percentage of Participants Achieving PASI 90 [Week 52]

   PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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 separately 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).

3. Percentage of Participants Achieving PASI 100 [Week 52]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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 separately 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).

4. Change From Baseline in PASI [Baseline, Week 52]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

5. Percent Improvement in PASI [Baseline, Week 52]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

6. Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement [Baseline, Week 52]

   The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous 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 analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

7. Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score [Baseline, Week 52]

   The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and 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 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

8. Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score [Baseline, Week 52]

   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 change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

9. Mean Change From Baseline in Palmoplantar PASI (PPASI) [Baseline, Week 52]

   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 PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

10. Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline [Baseline, Week 52]

    The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.

11. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1]) [Week 52]

    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). Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.

12. Change From Baseline in DLQI Total Score [Baseline, Week 52]

    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). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

13. Change From Baseline in Itch NRS Score [Baseline, Week 52]

    The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "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. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

14. Change From Baseline in Skin Pain Visual Analog Scale (VAS) [Baseline, Week 52]

    The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

15. Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS [Baseline, Week 52]

    EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

16. Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab [Predose, Week 4, 12, 24, 36 and 52 Post dose]

    Trough concentrations at steady state of Ixekizumab were evaluated.

17. Number of Participants With Anti-Ixekizumab Antibodies [Baseline through Week 52]

    Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.

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 psoriasis for at least 6 months prior to enrollment

• At least 10% BSA of psoriasis at screening and at enrollment

• sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment

• Candidates for phototherapy and/or systemic therapy

• Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion Criteria:

• Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis

• History of drug-induced psoriasis

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

• Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment

• Concurrent or recent use of any biologic agent

• Have participated in any study with ixekizumab

• Received a live vaccination within 12 weeks prior to enrollment

• Serious disorder or illness other than psoriasis

• Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis

• Major surgery within 8 weeks of baseline, or will require surgery during the study

• Breastfeeding or nursing (lactating) women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Skin and Beauty Dermatology Center PC	Birmingham	Alabama	United States	35205
2	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
3	David Stoll, M.D.	Beverly Hills	California	United States	90212
4	Dermatology Research Associates	Los Angeles	California	United States	90045
5	Center for Dermatology and Laser Surgery	Sacramento	California	United States	95819
6	Medical Center for Clinical Research	San Diego	California	United States	92108
7	University Clinical Trials, Inc.	San Diego	California	United States	92123
8	Clinical Science Institute	Santa Monica	California	United States	90404
9	Cherry Creek Research, Inc	Denver	Colorado	United States	80209
10	Florida Academic Dermatology Centers	Coral Gables	Florida	United States	33134
11	Avail Clinical Research LLC	DeLand	Florida	United States	32720
12	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
13	Renstar Medical Research	Ocala	Florida	United States	34471
14	Ameriderm Research	Ormond Beach	Florida	United States	32174
15	University of South Florida	Tampa	Florida	United States	33624
16	Advanced Medical Research	Atlanta	Georgia	United States	30342
17	University Dermatology	Darien	Illinois	United States	60561
18	Deaconess Clinic Inc	Evansville	Indiana	United States	47714
19	Dawes Fretzin Clinical Research	Indianapolis	Indiana	United States	46256
20	The South Bend Clinic	South Bend	Indiana	United States	46617
21	Kansas City Dermatology, PA	Overland Park	Kansas	United States	66215
22	Heartland Research Associates	Wichita	Kansas	United States	67207
23	Dermatology Specialist	Louisville	Kentucky	United States	40202
24	Dr. Shondra Smith MD	Lake Charles	Louisiana	United States	70605
25	DermAssociates, P.C.	Rockville	Maryland	United States	20850
26	ActivMed Practices & Research, Inc	Beverly	Massachusetts	United States	01915
27	Central Dermatology PC	Saint Louis	Missouri	United States	63117
28	ActivMed Practices & Research, Inc	Newington	New Hampshire	United States	03801
29	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey	United States	08520
30	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106-5239
31	Mount Sinai School of Medicine Dermatology Clinical Trials	New York	New York	United States	10029
32	Skin Search of Rochester, Inc	Rochester	New York	United States	14623
33	University of North Carolina Dermatology and Skin Cancer Center	Chapel Hill	North Carolina	United States	27516
34	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
35	Wilmington Dermatology Center	Wilmington	North Carolina	United States	28405
36	Piedmont Medical Research	Winston-Salem	North Carolina	United States	27103
37	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106-5055
38	Healthcare Research Consultant	Tulsa	Oklahoma	United States	74135
39	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
40	Oregon Medical Research Center	Portland	Oregon	United States	97223
41	Dermatology and Skin Surgery Center	Exton	Pennsylvania	United States	19341
42	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
43	Pennsylvania Regional Center for Arthritis & Osteoarthritis	Wyomissing	Pennsylvania	United States	19610
44	Yardley Dermatology	Yardley	Pennsylvania	United States	19067
45	Clinical Partners LLC	Johnston	Rhode Island	United States	02919
46	Coastal Carolina Research Center, Inc.	Mount Pleasant	South Carolina	United States	29464
47	The Skin Wellness Center PC	Knoxville	Tennessee	United States	37922
48	Austin Dermatology Associates	Austin	Texas	United States	78705
49	Menter Dermatology Research Institute	Dallas	Texas	United States	75246
50	Center for Clinical Studies	Houston	Texas	United States	77004
51	Center for Clinical Studies	Houston	Texas	United States	77065
52	Pflugerville Dermatology Clinical Research Center	Pflugerville	Texas	United States	78660
53	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
54	Center for Clinical Studies	Webster	Texas	United States	77598
55	University of Utah Medical Center	Salt Lake City	Utah	United States	84132
56	Virginia Clinical Research	Norfolk	Virginia	United States	23507
57	Dermatology Associates	Seattle	Washington	United States	98101
58	Multicare Health System	Tacoma	Washington	United States	98405
59	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington	United States	98801
60	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Buenos Aires		Argentina	C1425DKG
61	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mendoza		Argentina	5500
62	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Benowa		Australia	4217
63	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Carlton		Australia	3053
64	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Darlinghurst		Australia	2010
65	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Fremantle		Australia	6160
66	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Phillip		Australia	02606
67	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Woolloongabba		Australia	4102
68	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barrie		Canada	L4M 6L2
69	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Calgary		Canada	T2G 1B1
70	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Halifax		Canada	B3H1Z2
71	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hamilton		Canada	L8N1V6
72	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London		Canada	N6A 3H7
73	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Markham		Canada	L3P1X2
74	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Montreal		Canada	H2K4L5
75	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Oakville		Canada	L6J7W5
76	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Peterborough		Canada	K9J 5K2
77	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Quebec		Canada	G1V 4X7
78	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Richmond Hill		Canada	L4B 1A5
79	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sherbrooke		Canada	J1J 2G2
80	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Surrey		Canada	V3V 0C6
81	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Waterloo		Canada	N2J 1C4
82	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Windsor		Canada	N8W 1E6
83	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brno		Czechia	656 91
84	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Novy Jicin		Czechia	741 01
85	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Plzen-Bory		Czechia	305-99
86	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Praha		Czechia	100 34
87	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Berlin		Germany	10789
88	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Darmstadt		Germany	64283
89	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kiel		Germany	24148
90	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mahlow		Germany	15831
91	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Munster		Germany	48159
92	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Budapest		Hungary	1238
93	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Debrecen		Hungary	4032
94	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Oroshaza		Hungary	5901
95	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Szolnok		Hungary	5000
96	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Osaka		Japan	545-8586
97	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Takaoka		Japan	9330871
98	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tsu		Japan	514-8507
99	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bucheon		Korea, Republic of	420-717
100	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pusan		Korea, Republic of	602-739
101	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seongnam		Korea, Republic of	463-707
102	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seoul		Korea, Republic of	100799
103	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mexicali		Mexico	21100
104	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mexico City		Mexico	3100
105	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Monterrey		Mexico	64060
106	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Morelia		Mexico	CP 58249
107	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bialystok		Poland	15-351
108	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gdansk		Poland	80-546
109	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kielce		Poland	25-316
110	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Krakow		Poland	30-438
111	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lodz		Poland	90-265
112	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Swidnik		Poland	21-040
113	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Szczecin		Poland	70-332
114	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wroclaw		Poland	51-318
115	Office of Dr. Samuel Sanchez PSC	Caguas		Puerto Rico	00727
116	Office of Dr. Alma M. Cruz	Carolina		Puerto Rico	00985
117	Ponce School of Medicine CAIMED Center	Ponce		Puerto Rico	00716
118	GCM Medical Group PSC	San Juan		Puerto Rico	00909
119	Mindful Medical Research	San Juan		Puerto Rico	00918
120	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bucuresti		Romania	011025
121	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cluj Napoca		Romania	400006
122	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Constanta		Romania	900125
123	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Craiova		Romania	200642
124	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tainan		Taiwan	70166
125	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taipei		Taiwan	10048

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)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02513550
• Other Study ID Numbers: 15988; I1F-MC-RHBP; 2015-000190-12
• First Posted: Jul 31, 2015
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Psoriasis; Ixekizumab

Study Results

Participant Flow

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W	80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Period Title: Double Blind Treatment Period
STARTED	310	306	611	9	5	16
Received at Least One Dose of Study Drug	310	306	609	9	5	16
COMPLETED	274	268	537	9	4	15
NOT COMPLETED	36	38	74	0	1	1
Period Title: Double Blind Treatment Period
STARTED	285	283	559	9	4	15
COMPLETED	254	244	496	9	4	15
NOT COMPLETED	31	39	63	0	0	0

Baseline Characteristics

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W	80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort	80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort	Total
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.	Total of all reporting groups
Overall Participants	310	306	611	9	5	16	1257
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.4 (13.50)	45.9 (12.85)	49.0 (13.61)	40.0 (9.62)	46.0 (13.17)	46.1 (13.05)	47.8 (13.45)
Sex: Female, Male (Count of Participants)
Female	111 35.8%	107 35%	199 32.6%	2 22.2%	0 0%	4 25%	423 33.7%
Male	199 64.2%	199 65%	412 67.4%	7 77.8%	5 100%	12 75%	834 66.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	59 19%	55 18%	111 18.2%	0 0%	0 0%	0 0%	225 17.9%
Not Hispanic or Latino	243 78.4%	244 79.7%	489 80%	9 100%	5 100%	16 100%	1006 80%
Unknown or Not Reported	8 2.6%	7 2.3%	11 1.8%	0 0%	0 0%	0 0%	26 2.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	11 3.5%	12 3.9%	23 3.8%	0 0%	0 0%	0 0%	46 3.7%
Asian	31 10%	32 10.5%	64 10.5%	9 100%	5 100%	16 100%	157 12.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	4 0.7%	0 0%	0 0%	0 0%	4 0.3%
Black or African American	14 4.5%	8 2.6%	22 3.6%	0 0%	0 0%	0 0%	44 3.5%
White	251 81%	253 82.7%	486 79.5%	0 0%	0 0%	0 0%	990 78.8%
More than one race	3 1%	1 0.3%	12 2%	0 0%	0 0%	0 0%	16 1.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Puerto Rico	14 4.5%	16 5.2%	29 4.7%	0 0%	0 0%	0 0%	59 4.7%
Argentina	9 2.9%	9 2.9%	19 3.1%	0 0%	0 0%	0 0%	37 2.9%
Romania	5 1.6%	5 1.6%	9 1.5%	0 0%	0 0%	0 0%	19 1.5%
Hungary	11 3.5%	10 3.3%	23 3.8%	0 0%	0 0%	0 0%	44 3.5%
United States	119 38.4%	118 38.6%	238 39%	0 0%	0 0%	0 0%	475 37.8%
Czechia	3 1%	3 1%	8 1.3%	0 0%	0 0%	0 0%	14 1.1%
Japan	5 1.6%	2 0.7%	9 1.5%	0 0%	0 0%	0 0%	16 1.3%
Canada	49 15.8%	49 16%	99 16.2%	0 0%	0 0%	0 0%	197 15.7%
South Korea	11 3.5%	12 3.9%	22 3.6%	9 100%	5 100%	16 100%	75 6%
Taiwan	5 1.6%	6 2%	9 1.5%	0 0%	0 0%	0 0%	20 1.6%
Poland	43 13.9%	43 14.1%	83 13.6%	0 0%	0 0%	0 0%	169 13.4%
Mexico	10 3.2%	8 2.6%	17 2.8%	0 0%	0 0%	0 0%	35 2.8%
Australia	14 4.5%	14 4.6%	28 4.6%	0 0%	0 0%	0 0%	56 4.5%
Germany	12 3.9%	11 3.6%	18 2.9%	0 0%	0 0%	0 0%	41 3.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Description	The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was 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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	310	306	611
Number [Percentage of participants]	70.6 22.8%	72.5 23.7%	78.6 12.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.005
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	7.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q4W/Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.522
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants Achieving 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) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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 separately 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). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	310	306	611
Number [Percentage of participants]	79 25.5%	83.7 27.4%	85.9 14.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.006
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	6.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	80 mg Ixekizumab Q4W, 80 mg Ixekizumab Q4W/Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.118
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	4.6
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Achieving sPGA (0)
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. Participant's Ps was 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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	310	306	611
Number [Percentage of participants]	44.8 14.5%	48.7 15.9%	60.1 9.8%

4. Secondary Outcome

Title	Percentage of Participants Achieving PASI 90
Description	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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 separately 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 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	310	306	611
Number [Percentage of participants]	65.2 21%	73.9 24.2%	79.5 13%

5. Secondary Outcome

Title	Percentage of Participants Achieving PASI 100
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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 separately 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 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	310	306	611
Number [Percentage of participants]	43.5 14%	49.3 16.1%	59.7 9.8%

6. Secondary Outcome

Title	Change From Baseline in PASI
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	274	268	538
Least Squares Mean (Standard Error) [units on a scale]	-18.34 (0.22)	-18.95 (0.22)	-19.41 (0.17)

7. Secondary Outcome

Title	Percent Improvement in PASI
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	274	268	538
Least Squares Mean (Standard Error) [Percent change]	91.09 (0.89)	94.24 (0.90)	96.25 (0.71)

8. Secondary Outcome

Title	Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
Description	The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous 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 analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned who had baseline and a post-baseline measurement for BSA affected by Psoriasis. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	274	268	538
Least Squares Mean (Standard Error) [Percent Body Surface Affected]	-23.93 (0.34)	-24.62 (0.34)	-25.01 (0.27)

9. Secondary Outcome

Title	Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Description	The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and 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 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned who had baseline fingernail involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	156	148	314
Least Squares Mean (Standard Error) [units on a scale]	-19.27 (0.81)	-19.87 (0.83)	-20.82 (0.62)

10. Secondary Outcome

Title	Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
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 change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and had baseline scalp involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	252	245	477
Least Squares Mean (Standard Error) [units on a scale]	-18.35 (0.31)	-18.73 (0.31)	-18.65 (0.24)

11. Secondary Outcome

Title	Mean Change From Baseline in Palmoplantar PASI (PPASI)
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 PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and had baseline palmoplantar Ps involvement and had post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	72	82	150
Least Squares Mean (Standard Error) [units on a scale]	-9.55 (0.31)	-9.37 (0.30)	-9.00 (0.26)

12. Secondary Outcome

Title	Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
Description	The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and who had baseline Itch NRS score greater than or equal to (>=) 4. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	254	260	505
Number [Percentage of participants]	74.0 23.9%	72.3 23.6%	77.2 12.6%

13. Secondary Outcome

Title	Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
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). Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	310	306	611
Number [Percentage of participants]	66.1 21.3%	70.3 23%	74.0 12.1%

14. Secondary Outcome

Title	Change From Baseline in 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). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline DLQI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind..	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	273	265	538
Least Squares Mean (Standard Error) [units on a scale]	-9.70 (0.21)	-9.97 (0.22)	-10.23 (0.17)

15. Secondary Outcome

Title	Change From Baseline in Itch NRS Score
Description	The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "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. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline Itch NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	274	268	537
Least Squares Mean (Standard Error) [units on a scale]	-4.90 (0.13)	-5.15 (0.13)	-5.33 (0.10)

16. Secondary Outcome

Title	Change From Baseline in Skin Pain Visual Analog Scale (VAS)
Description	The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline skin pain VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	271	262	532
Least Squares Mean (Standard Error) [mm]	-35.50 (0.94)	-36.77 (0.96)	-38.07 (0.74)

17. Secondary Outcome

Title	Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
Description	EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post baseline EQ-5D-5L VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	268	264	519
Least Squares Mean (Standard Error) [mm]	11.93 (0.94)	12.47 (0.95)	14.42 (0.74)

18. Secondary Outcome

Title	Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Description	Trough concentrations at steady state of Ixekizumab were evaluated.
Time Frame	Predose, Week 4, 12, 24, 36 and 52 Post dose

Outcome Measure Data

Analysis Population Description

All randomized participants analyzed according to treatment to which they were assigned with evaluable PK samples that met the definition of being a trough concentration. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W Continuous	80 mg Ixekizumab Q4W/Q2W No Step	80 mg Ixekizumab Q4W/Q2W Step up	80 mg Ixekizumab Q2W Continuous
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	304	232	73	602
Week 4	3.55 (76)	4.03 (72)	2.78 (67)	7.87 (63)
Week 12	2.72 (72)	2.81 (80)	1.95 (70)	8.23 (56)
Week 24	2.65 (73)	2.71 (85)	3.48 (78)	7.89 (66)
Week 36	2.83 (74)	2.88 (73)	5.76 (67)	7.73 (76)
Week 52	2.43 (79)	2.77 (73)	5.73 (68)	6.96 (87)

19. Secondary Outcome

Title	Number of Participants With Anti-Ixekizumab Antibodies
Description	Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
Time Frame	Baseline through Week 52

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of Ixekizumab and had evaluable anti-ixekizumab antibody measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title	80 mg Ixekizumab Q4W	80 mg Ixekizumab Q4W/Q2W	80 mg Ixekizumab Q2W
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Measure Participants	307	305	606
Number [participants]	71 22.9%	64 20.9%	84 13.7%

Adverse Events

Time Frame	Up to 19 months
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	Ixekizumab 80 mg Q4W - Treatment Period		80 mg Ixekizumab Q4W/Q2W - Treatment Period		80 mg Ixekizumab Q2W - Treatment Period		80 mg Ixekizumab Q4W - Post-Treatment Period		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period		80 mg Ixekizumab Q2W - Post-Treatment Period		80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
Arm/Group Description	160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.		160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.		160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.		Participants didn't receive any intervention.		Participants didn't receive any intervention.		Participants didn't receive any intervention.		160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.		160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.		160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.		Participants didn't receive any intervention.		Participants didn't receive any intervention.		Participants didn't receive any intervention.
All Cause Mortality
	Ixekizumab 80 mg Q4W - Treatment Period		80 mg Ixekizumab Q4W/Q2W - Treatment Period		80 mg Ixekizumab Q2W - Treatment Period		80 mg Ixekizumab Q4W - Post-Treatment Period		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period		80 mg Ixekizumab Q2W - Post-Treatment Period		80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
	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	0/310 (0%)		0/306 (0%)		0/609 (0%)		0/285 (0%)		0/283 (0%)		0/559 (0%)		0/9 (0%)		0/5 (0%)		0/16 (0%)		0/9 (0%)		0/4 (0%)		0/15 (0%)
Serious Adverse Events
	Ixekizumab 80 mg Q4W - Treatment Period		80 mg Ixekizumab Q4W/Q2W - Treatment Period		80 mg Ixekizumab Q2W - Treatment Period		80 mg Ixekizumab Q4W - Post-Treatment Period		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period		80 mg Ixekizumab Q2W - Post-Treatment Period		80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
	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	16/310 (5.2%)		16/306 (5.2%)		32/609 (5.3%)		1/285 (0.4%)		2/283 (0.7%)		7/559 (1.3%)		0/9 (0%)		1/5 (20%)		0/16 (0%)		0/9 (0%)		0/4 (0%)		0/15 (0%)
Cardiac disorders
Acute myocardial infarction	1/310 (0.3%)	1	0/306 (0%)	0	1/609 (0.2%)	3	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Atrial fibrillation	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Cardiac failure	0/310 (0%)	0	0/306 (0%)	0	2/609 (0.3%)	2	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Coronary artery disease	0/310 (0%)	0	1/306 (0.3%)	2	2/609 (0.3%)	2	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Myocardial infarction	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Pericarditis	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Ear and labyrinth disorders
Vertigo	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Endocrine disorders
Goitre	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Eye disorders
Retinal detachment	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gastrointestinal disorders
Colitis ulcerative	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Crohn's disease	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gastroenteritis eosinophilic	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	2	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gastrointestinal haemorrhage	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Intra-abdominal haematoma	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Oesophageal rupture	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Pancreatitis	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Umbilical hernia	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
General disorders
Chest discomfort	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Non-cardiac chest pain	1/310 (0.3%)	1	0/306 (0%)	0	2/609 (0.3%)	2	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Vascular stent restenosis	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Cholecystitis chronic	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Cholelithiasis	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Immune system disorders
Drug hypersensitivity	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Infections and infestations
Abscess limb	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Abscess oral	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Appendicitis	0/310 (0%)	0	1/306 (0.3%)	1	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Carbuncle	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Cellulitis	2/310 (0.6%)	2	2/306 (0.7%)	2	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Chronic sinusitis	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Chronic tonsillitis	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gastroenteritis shigella	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Pneumonia	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Pyelonephritis	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Pyelonephritis acute	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Sepsis	1/310 (0.3%)	1	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Urosepsis	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Injury, poisoning and procedural complications
Clavicle fracture	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Fall	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Femur fracture	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Hand fracture	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Injury	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Joint dislocation	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Lower limb fracture	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Pelvic fracture	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Rib fracture	0/310 (0%)	0	2/306 (0.7%)	2	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Road traffic accident	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Wound dehiscence	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Investigations
International normalised ratio increased	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gout	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Hypokalaemia	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Lactic acidosis	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Cartilage hypertrophy	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Intervertebral disc compression	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Musculoskeletal chest pain	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	2	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Adenocarcinoma gastric	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Adenocarcinoma of colon	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Benign bone neoplasm	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	1/5 (20%)	1	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Breast cancer metastatic	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	1/283 (0.4%)	1	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Colon cancer	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Dermatofibrosarcoma protuberans	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Invasive breast carcinoma	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Invasive ductal breast carcinoma	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Neurilemmoma benign	0/310 (0%)	0	1/306 (0.3%)	1	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Plasma cell myeloma	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	1/285 (0.4%)	1	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Nervous system disorders
Basilar migraine	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Cerebrovascular accident	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	1/283 (0.4%)	1	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Hyposmia	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Transient ischaemic attack	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy	0/111 (0%)	0	0/107 (0%)	0	0/199 (0%)	0	0/98 (0%)	0	0/98 (0%)	0	1/184 (0.5%)	1	0/2 (0%)	0	0/0 (NaN)	0	0/4 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/4 (0%)	0
Tubal rupture	0/111 (0%)	0	0/107 (0%)	0	0/199 (0%)	0	0/98 (0%)	0	0/98 (0%)	0	1/184 (0.5%)	1	0/2 (0%)	0	0/0 (NaN)	0	0/4 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/4 (0%)	0
Psychiatric disorders
Anxiety	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Depression	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Major depression	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Stress	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Suicide attempt	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Renal and urinary disorders
Renal haematoma	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Urinary retention	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/199 (0.5%)	1	0/199 (0%)	0	0/410 (0%)	0	0/187 (0%)	0	0/185 (0%)	0	0/375 (0%)	0	0/7 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/7 (0%)	0	0/4 (0%)	0	0/11 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis contact	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Psoriasis	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Rash macular	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Stevens-johnson syndrome	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Vascular disorders
Deep vein thrombosis	0/310 (0%)	0	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Other (Not Including Serious) Adverse Events
	Ixekizumab 80 mg Q4W - Treatment Period		80 mg Ixekizumab Q4W/Q2W - Treatment Period		80 mg Ixekizumab Q2W - Treatment Period		80 mg Ixekizumab Q4W - Post-Treatment Period		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period		80 mg Ixekizumab Q2W - Post-Treatment Period		80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort		80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
	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	157/310 (50.6%)		136/306 (44.4%)		285/609 (46.8%)		16/285 (5.6%)		20/283 (7.1%)		40/559 (7.2%)		6/9 (66.7%)		4/5 (80%)		11/16 (68.8%)		2/9 (22.2%)		0/4 (0%)		2/15 (13.3%)
Blood and lymphatic system disorders
Neutropenia	2/310 (0.6%)	2	0/306 (0%)	0	1/609 (0.2%)	2	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Eye disorders
Retinal vein occlusion	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gastrointestinal disorders
Dry mouth	0/310 (0%)	0	2/306 (0.7%)	2	2/609 (0.3%)	2	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Dyspepsia	2/310 (0.6%)	2	1/306 (0.3%)	1	4/609 (0.7%)	4	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gastric ulcer	1/310 (0.3%)	1	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Gastritis	3/310 (1%)	3	1/306 (0.3%)	1	4/609 (0.7%)	4	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Mouth ulceration	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
General disorders
Injection site erythema	4/310 (1.3%)	14	3/306 (1%)	4	18/609 (3%)	49	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	2/16 (12.5%)	24	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Injection site oedema	1/310 (0.3%)	4	0/306 (0%)	0	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	2/16 (12.5%)	24	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Injection site pain	4/310 (1.3%)	4	6/306 (2%)	7	8/609 (1.3%)	26	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Injection site pruritus	1/310 (0.3%)	4	0/306 (0%)	0	4/609 (0.7%)	13	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Injection site reaction	18/310 (5.8%)	68	5/306 (1.6%)	15	49/609 (8%)	256	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Injection site swelling	2/310 (0.6%)	11	0/306 (0%)	0	7/609 (1.1%)	11	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Xerosis	1/310 (0.3%)	1	2/306 (0.7%)	2	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Infections and infestations
Furuncle	3/310 (1%)	3	1/306 (0.3%)	1	5/609 (0.8%)	5	1/285 (0.4%)	1	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Hordeolum	4/310 (1.3%)	7	2/306 (0.7%)	2	4/609 (0.7%)	4	0/285 (0%)	0	1/283 (0.4%)	1	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/15 (0%)	0
Influenza	6/310 (1.9%)	6	9/306 (2.9%)	10	5/609 (0.8%)	5	1/285 (0.4%)	1	2/283 (0.7%)	2	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Mumps	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	1/5 (20%)	1	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Otitis externa	3/310 (1%)	4	3/306 (1%)	4	8/609 (1.3%)	8	0/285 (0%)	0	1/283 (0.4%)	1	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Tinea pedis	6/310 (1.9%)	6	4/306 (1.3%)	4	8/609 (1.3%)	10	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Tonsillitis	1/310 (0.3%)	2	2/306 (0.7%)	2	6/609 (1%)	6	0/285 (0%)	0	0/283 (0%)	0	2/559 (0.4%)	2	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Upper respiratory tract infection	46/310 (14.8%)	60	39/306 (12.7%)	56	69/609 (11.3%)	93	1/285 (0.4%)	1	3/283 (1.1%)	3	3/559 (0.5%)	3	2/9 (22.2%)	2	1/5 (20%)	1	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Urinary tract infection	16/310 (5.2%)	21	4/306 (1.3%)	4	15/609 (2.5%)	20	0/285 (0%)	0	2/283 (0.7%)	2	6/559 (1.1%)	6	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Vaginal infection	0/111 (0%)	0	1/107 (0.9%)	1	0/199 (0%)	0	0/98 (0%)	0	0/98 (0%)	0	0/184 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	1/4 (25%)	1	0/2 (0%)	0	0/0 (NaN)	0	0/4 (0%)	0
Viral upper respiratory tract infection	41/310 (13.2%)	49	53/306 (17.3%)	69	73/609 (12%)	89	6/285 (2.1%)	7	0/283 (0%)	0	9/559 (1.6%)	9	1/9 (11.1%)	1	1/5 (20%)	1	6/16 (37.5%)	9	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Investigations
Alanine aminotransferase increased	7/310 (2.3%)	7	2/306 (0.7%)	2	3/609 (0.5%)	3	0/285 (0%)	0	1/283 (0.4%)	1	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Aspartate aminotransferase increased	5/310 (1.6%)	5	2/306 (0.7%)	2	3/609 (0.5%)	3	0/285 (0%)	0	1/283 (0.4%)	1	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Blood glucose increased	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	1/283 (0.4%)	1	0/559 (0%)	0	0/9 (0%)	0	1/5 (20%)	1	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Helicobacter test positive	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	7/310 (2.3%)	8	5/306 (1.6%)	5	25/609 (4.1%)	29	2/285 (0.7%)	3	1/283 (0.4%)	1	4/559 (0.7%)	4	0/9 (0%)	0	1/5 (20%)	1	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Myalgia	2/310 (0.6%)	2	0/306 (0%)	0	6/609 (1%)	6	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	2/16 (12.5%)	2	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Osteoarthritis	4/310 (1.3%)	4	2/306 (0.7%)	2	4/609 (0.7%)	4	0/285 (0%)	0	1/283 (0.4%)	1	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Periarthritis	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	1/5 (20%)	1	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Nervous system disorders
Dizziness	1/310 (0.3%)	1	0/306 (0%)	0	9/609 (1.5%)	10	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Headache	14/310 (4.5%)	16	16/306 (5.2%)	18	29/609 (4.8%)	34	0/285 (0%)	0	1/283 (0.4%)	1	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	11/310 (3.5%)	11	2/306 (0.7%)	3	23/609 (3.8%)	25	1/285 (0.4%)	1	1/283 (0.4%)	1	2/559 (0.4%)	2	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/15 (6.7%)	1
Dysphonia	0/310 (0%)	0	0/306 (0%)	0	0/609 (0%)	0	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Epistaxis	1/310 (0.3%)	1	0/306 (0%)	0	3/609 (0.5%)	3	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Oropharyngeal pain	6/310 (1.9%)	6	5/306 (1.6%)	5	17/609 (2.8%)	17	0/285 (0%)	0	0/283 (0%)	0	1/559 (0.2%)	1	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Skin and subcutaneous tissue disorders
Dermal cyst	2/310 (0.6%)	2	1/306 (0.3%)	1	2/609 (0.3%)	2	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Dry skin	0/310 (0%)	0	1/306 (0.3%)	1	1/609 (0.2%)	1	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Dyshidrotic eczema	2/310 (0.6%)	2	1/306 (0.3%)	1	2/609 (0.3%)	2	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	0/9 (0%)	0	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Eczema	6/310 (1.9%)	8	5/306 (1.6%)	6	11/609 (1.8%)	12	1/285 (0.4%)	1	0/283 (0%)	0	1/559 (0.2%)	1	1/9 (11.1%)	2	0/5 (0%)	0	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Psoriasis	4/310 (1.3%)	4	3/306 (1%)	3	3/609 (0.5%)	3	3/285 (1.1%)	4	5/283 (1.8%)	5	6/559 (1.1%)	7	0/9 (0%)	0	0/5 (0%)	0	0/16 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	1/15 (6.7%)	1
Rash	3/310 (1%)	3	3/306 (1%)	3	4/609 (0.7%)	4	0/285 (0%)	0	0/283 (0%)	0	3/559 (0.5%)	5	0/9 (0%)	0	1/5 (20%)	1	0/16 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0
Urticaria	3/310 (1%)	3	4/306 (1.3%)	4	6/609 (1%)	7	0/285 (0%)	0	0/283 (0%)	0	0/559 (0%)	0	1/9 (11.1%)	1	0/5 (0%)	0	1/16 (6.3%)	1	0/9 (0%)	0	0/4 (0%)	0	0/15 (0%)	0

Limitations/Caveats

[Not Specified]

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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.