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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02561806
• Collaborator: (none)
• Enrollment: 302
• Locations: 48
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 302 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ustekinumab 45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.	Drug: Ustekinumab; Administered SC; Drug: Placebo; Administered SC
Experimental: Ixekizumab 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821 ; Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline [Week 12]

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

Secondary Outcome Measures

1. Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline [Week 12]

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

2. Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline [Week 12]

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

3. Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline [Week 12]

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

4. Percentage of Participants With a sPGA (0) Remission [Week 12]

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

5. Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis [Baseline, Week 12]

   The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group as fixed effects.

6. Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score [Baseline, Week 12]

   The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

7. Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score [Baseline, Week 12]

   The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

8. Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score [Baseline, Week 12]

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

9. Change From Baseline in Itch Numeric Rating Scale (NRS) [Baseline, Week 12]

   The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

10. Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100) [Baseline, Week 12]

    Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

11. Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1) [Week 12]

    The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life.

12. Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale [Baseline, Week 12]

    The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

13. Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale. [Baseline, Week 12]

    The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

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

    The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

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

    The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

16. Change From Baseline on Patient Global Assessment of Disease Severity (PatGA) [Baseline, Week 12]

    The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

17. Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index [Baseline, Week 12]

    The European Quality of Life - 5 Dimensions 5 Level (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 a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health). ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

18. Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS [Baseline, Week 12]

    The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

19. Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score [Baseline, Week 12]

    The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

20. Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism [Baseline, Week 12]

    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

21. Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism [Baseline, Week 12]

    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

22. Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score. [Baseline, Week 12]

    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

23. Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work [Baseline, Week 12]

    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Chronic plaque psoriasis for at least 6 months before baseline

• Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)

• Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline

• Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment

Exclusion Criteria:

• Predominant pattern of pustular, erythrodermic, and/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 before baseline and during the study

• Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline

• Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline

• Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol

• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists

• Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study

• Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study

• Have a known allergy or hypersensitivity to latex

• Have had any major surgery within 8 weeks of baseline or will require such during the study

• Have active or history of malignant disease within 5 years prior to baseline

• Significant uncontrolled disorder

• Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline

• Are women who are lactating or breast-feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.	Wein		Austria	1090
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brussels		Belgium	1200
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gent		Belgium	9000
4	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Calgary		Canada	T3A 2N1
5	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Edmonton		Canada	T5K 1X3
6	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Mississauga		Canada	L5H 1GO
7	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	North Bay		Canada	P1B 3Z7
8	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	St. John's		Canada	A1A4Y3
9	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Toronto		Canada	M3H 5Y8
10	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.	Marseille		France	13008
11	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.	Martigues		France	13500
12	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.	Nice		France	06202
13	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.	Rouen		France	76031
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Toulouse		France	31059
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Frankfurt am Main		Germany	60590
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Giessen		Germany	35390
17	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hamburg		Germany	20354
18	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Heidelberg		Germany	69120
19	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kiel		Germany	24148
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lübeck		Germany	23538
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	München		Germany	80802
22	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tübingen		Germany	72076
23	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Witten		Germany	58453
24	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	1135
25	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.	Kecskemet		Hungary	6000
26	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.	Szeged		Hungary	6720
27	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
28	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.	Catania		Italy	95125
29	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pisa		Italy	56100
30	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nijmegen		Netherlands	6525 GL
31	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
32	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lodz		Poland	90-265
33	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Swidnik		Poland	21-040
34	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warsaw		Poland	01-142
35	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.	Warsaw		Poland	01-518
36	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.	Warszawa		Poland	02-507
37	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.	Badalona		Spain	08916
38	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.	Barcelona		Spain	08041
39	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.	Madrid		Spain	28031
40	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.	Madrid		Spain	28041
41	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.	Sevilla		Spain	41071
42	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.	Malmö		Sweden	20502
43	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.	Stockholm		Sweden	SE-118 83
44	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.	Genève		Switzerland	1211
45	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.	Lausanne		Switzerland	1011
46	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.	Zürich		Switzerland	8091
47	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.	Dundee		United Kingdom	DD1 9SY
48	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.	Salford		United Kingdom	M6 8HD

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: NCT02561806
• Other Study ID Numbers: 16012; I1F-MC-RHBS; 2015-000892-28
• First Posted: Sep 28, 2015
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Psoriasis; Ustekinumab; Ixekizumab

Study Results

Participant Flow

Recruitment Details	Induction period occurring from week 0 to week 12 followed by maintenance period occurring week 12 to week 52 followed by post-treatment follow-up period occurring from last treatment period visit (week 52) or Early termination visit, for a minimum of 12 weeks following that visit.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.	160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Period Title: Induction Period
STARTED	166	136
Received At Least One Dose of Study Drug	166	135
COMPLETED	164	131
NOT COMPLETED	2	5
Period Title: Induction Period
STARTED	164	131
COMPLETED	151	123
NOT COMPLETED	13	8
Period Title: Induction Period
STARTED	157	60
COMPLETED	155	59
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Ustekinumab	Ixekizumab	Total
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.	Total of all reporting groups
Overall Participants	166	136	302
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	44 (13.25)	42.7 (12.67)	43.4 (12.99)
Sex: Female, Male (Count of Participants)
Female	54 32.5%	46 33.8%	100 33.1%
Male	112 67.5%	90 66.2%	202 66.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 3%	4 2.9%	9 3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 0.6%	3 2.2%	4 1.3%
White	157 94.6%	125 91.9%	282 93.4%
More than one race	1 0.6%	2 1.5%	3 1%
Unknown or Not Reported	2 1.2%	2 1.5%	4 1.3%
Region of Enrollment (Count of Participants)
Hungary	12 7.2%	11 8.1%	23 7.6%
United Kingdom	4 2.4%	2 1.5%	6 2%
Switzerland	6 3.6%	5 3.7%	11 3.6%
Spain	13 7.8%	12 8.8%	25 8.3%
Canada	27 16.3%	25 18.4%	52 17.2%
Austria	6 3.6%	6 4.4%	12 4%
Netherlands	0 0%	1 0.7%	1 0.3%
Sweden	4 2.4%	2 1.5%	6 2%
Belgium	4 2.4%	2 1.5%	6 2%
Poland	21 12.7%	17 12.5%	38 12.6%
Italy	4 2.4%	4 2.9%	8 2.6%
France	25 15.1%	23 16.9%	48 15.9%
Germany	40 24.1%	26 19.1%	66 21.9%
Weight (Kilogram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram]	89.4 (24.5)	85.8 (20.30)	87.8 (22.90)
Weight Categorical (Count of Participants)
<= 100 kg	121 72.9%	104 76.5%	225 74.5%
> 100 kg	45 27.1%	31 22.8%	76 25.2%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.7 (6.97)	28.8 (5.55)	29.3 (6.38)
Duration of psoriasis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.2 (12.0)	18.0 (11.14)	18.1 (11.60)
Age group at psoriasis onset (Count of Participants)
<40 years (Type 1 psoriasis)	134 80.7%	113 83.1%	247 81.8%
>=40 years (Type 2 psoriasis)	32 19.3%	23 16.9%	55 18.2%
Psoriasis Area & Severity Index (PASI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	19.8 (9.02)	19.9 (8.15)	19.9 (8.62)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Measure Participants	166	136
Number [percentage of participants]	42.2 25.4%	72.8 53.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ustekinumab, Ixekizumab
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority margin was -12.6% for 97.5% confidence interval
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.321
	Confidence Interval	(2-Sided) 97.5%; 0.198 to 0.445
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding. Ustekinumab: Administered SC	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding. Ixekizumab: Administered SC
Measure Participants	166	136
Number [percentage of participants]	68.7 41.4%	88.2 64.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ustekinumab, Ixekizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.285
	Confidence Interval	(2-Sided) 95%; 1.130 to 1.439
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	166	136
Number [percentage of participants]	14.5 8.7%	36 26.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ustekinumab, Ixekizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.699
	Confidence Interval	(2-Sided) 95%; 1.423 to 3.975
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding. Ustekinumab: Administered SC	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding. Ixekizumab: Administered SC
Measure Participants	166	134
Number [percentage of participants]	57.2 34.5%	83.6 61.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ustekinumab, Ixekizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.469
	Confidence Interval	(2-Sided) 95%; 1.244 to 1.695
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	166	136
Number [percentage of participants]	18.1 10.9%	41.9 30.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ustekinumab, Ixekizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.021
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	3.421
	Confidence Interval	(2-Sided) 95%; 1.353 to 5.488
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis
Description	The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug & had a baseline & post-baseline measurement for BSA affected by Ps. mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Measure Participants	164	135
Least Squares Mean (95% Confidence Interval) [Percent Body Surface Affected]	-16.92	-22.55

7. Secondary Outcome

Title	Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
Description	The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants(Pts) who had psoriasis in palmoplantar regions at baseline & received at least 1 dose of study drug & had baseline & post-baseline PPASI data. mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, Pts who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding. Ustekinumab: Administered SC	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding. Ixekizumab: Administered SC
Measure Participants	28	35
Least Squares Mean (95% Confidence Interval) [units on a scale]	-8.34	-10.31

8. Secondary Outcome

Title	Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total 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). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who had psoriasis in scalp region at baseline & received at least 1 dose of study drug & had baseline & post-baseline PSSI data. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	152	119
Least Squares Mean (95% Confidence Interval) [units on a scale]	-16.00	-19.29

9. Secondary Outcome

Title	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score
Description	NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who had nail psoriasis at baseline & received at least 1 dose of study drug and had baseline & post-baseline NAPSI measurement. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding. Ixekizumab: Administered SC
Measure Participants	103	84
Least Squares Mean (95% Confidence Interval) [units on a scale]	-5.02	-12.24

10. Secondary Outcome

Title	Change From Baseline in Itch Numeric Rating Scale (NRS)
Description	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Itch NRS. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	165	135
Least Squares Mean (95% Confidence Interval) [units on a scale]	-4.12	-4.56

11. Secondary Outcome

Title	Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)
Description	Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for skin pain VAS. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	165	135
Least Squares Mean (95% Confidence Interval) [mm]	-29.92	-33.32

12. Secondary Outcome

Title	Percentage of Participants With Dermatology Life Quality Index (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). A score of 0 or 1 indicates no impact of disease on a participants quality of life.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Measure Participants	166	136
Number [percentage of participants]	44.6 26.9%	61.0 44.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ustekinumab, Ixekizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.391
	Confidence Interval	(2-Sided) 95%; 1.085 to 1.698
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale
Description	The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for HADS depression subscale. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Measure Participants	162	134
Least Squares Mean (95% Confidence Interval) [units on a scale]	-0.96	-1.20

14. Secondary Outcome

Title	Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.
Description	The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for HADS anxiety subscale. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Measure Participants	162	134
Least Squares Mean (95% Confidence Interval) [units on a scale]	-0.90	-1.27

15. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;
Description	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF-36 PCS score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was be used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	164	133
Least Squares Mean (95% Confidence Interval) [units on a scale]	3.10	5.03

16. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score
Description	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF36 MCS score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	164	133
Least Squares Mean (95% Confidence Interval) [units on a scale]	2.36	2.96

17. Secondary Outcome

Title	Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)
Description	The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PatGA. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	164	135
Least Squares Mean (95% Confidence Interval) [units on a scale]	-2.60	-3.07

18. Secondary Outcome

Title	Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index
Description	The European Quality of Life - 5 Dimensions 5 Level (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 a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health). ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L "Bolt On" PSO-Index. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
Measure Participants	165	134
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.11	0.15

19. Secondary Outcome

Title	Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS
Description	The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L VAS. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injectio was used for blinding.
Measure Participants	163	134
Least Squares Mean (95% Confidence Interval) [mm]	8.75	12.24

20. Secondary Outcome

Title	Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score
Description	The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug & had baseline & post-baseline EQ-5D 5L UK population-based index score measurement. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
Measure Participants	165	134
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.12	0.15

21. Secondary Outcome

Title	Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism
Description	The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	90	87
Least Squares Mean (95% Confidence Interval) [units on a scale]	-1.42	-0.46

22. Secondary Outcome

Title	Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism
Description	The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO presenteeism score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	98	92
Least Squares Mean (95% Confidence Interval) [units on a scale]	-15.53	-16.91

23. Secondary Outcome

Title	Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.
Description	The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO work impairment score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	90	87
Least Squares Mean (95% Confidence Interval) [units on a scale]	-15.05	-16.27

24. Secondary Outcome

Title	Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work
Description	The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants(Pts) who received at least 1 dose of study drug & had baseline & post-baseline data for WPAI-PSO impairment in activities performed outside work. mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, pts who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title	Ustekinumab	Ixekizumab
Arm/Group Description	45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injection was used for blinding.	160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injection was used for blinding.
Measure Participants	154	127
Least Squares Mean (95% Confidence Interval) [units on a scale]	-19.14	-23.06

Adverse Events

Adverse Event Reporting Description	All randomized participants who received at least one dose study drug.
Arm/Group Title	Ustekinumab - Induction		Ixekizumab - Induction		Ustekinumab - Maintenance		Ixekizumab - Maintenance		Ustekinumab - Post Treatment Follow up		Ixekizumab - Post Treatment Follow up
Arm/Group Description	45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding.		160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks. Placebo for Ustekinumab injection was used for blinding.		45 milligram (mg) Ustekinumab given as Subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding.		80 mg Ixekizumab given as a single SC injection once every 4 weeks. Placebo for Ustekinumab injection was used for blinding.		Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.		Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
All Cause Mortality
	Ustekinumab - Induction		Ixekizumab - Induction		Ustekinumab - Maintenance		Ixekizumab - Maintenance		Ustekinumab - Post Treatment Follow up		Ixekizumab - Post Treatment Follow up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ustekinumab - Induction		Ixekizumab - Induction		Ustekinumab - Maintenance		Ixekizumab - Maintenance		Ustekinumab - Post Treatment Follow up		Ixekizumab - Post Treatment Follow up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/166 (0%)		2/135 (1.5%)		6/164 (3.7%)		7/131 (5.3%)		2/157 (1.3%)		0/60 (0%)
Cardiac disorders
Angina unstable	0/166 (0%)	0	1/135 (0.7%)	1	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Myocardial infarction	0/166 (0%)	0	0/135 (0%)	0	1/164 (0.6%)	1	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Gastrointestinal disorders
Rectal haemorrhage	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	1/131 (0.8%)	1	0/157 (0%)	0	0/60 (0%)	0
Tooth impacted	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	0/166 (0%)	0	0/135 (0%)	0	1/164 (0.6%)	1	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Cholelithiasis	0/166 (0%)	0	0/135 (0%)	0	1/164 (0.6%)	1	1/131 (0.8%)	1	0/157 (0%)	0	0/60 (0%)	0
Infections and infestations
Erysipelas	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	1/157 (0.6%)	1	0/60 (0%)	0
Gastroenteritis bacterial	0/166 (0%)	0	1/135 (0.7%)	1	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Injury, poisoning and procedural complications
Ankle fracture	0/166 (0%)	0	0/135 (0%)	0	1/164 (0.6%)	1	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Clavicle fracture	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Humerus fracture	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Metabolism and nutrition disorders
Obesity	0/166 (0%)	0	0/135 (0%)	0	1/164 (0.6%)	1	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	1/131 (0.8%)	1	0/157 (0%)	0	0/60 (0%)	0
Pseudarthrosis	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	1/131 (0.8%)	1	0/157 (0%)	0	0/60 (0%)	0
Psoriatic arthropathy	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	1/157 (0.6%)	1	0/60 (0%)	0
Rotator cuff syndrome	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	1/131 (0.8%)	1	0/157 (0%)	0	0/60 (0%)	0
Nervous system disorders
Carotid arteriosclerosis	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Carotid artery stenosis	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Ischaemic stroke	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Psychiatric disorders
Depression	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	1/131 (0.8%)	1	0/157 (0%)	0	0/60 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/166 (0%)	0	0/135 (0%)	0	1/164 (0.6%)	1	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Skin and subcutaneous tissue disorders
Eczema	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	1/131 (0.8%)	1	0/157 (0%)	0	0/60 (0%)	0
Vascular disorders
Hypertensive crisis	0/166 (0%)	0	0/135 (0%)	0	0/164 (0%)	0	0/131 (0%)	0	0/157 (0%)	0	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Ustekinumab - Induction		Ixekizumab - Induction		Ustekinumab - Maintenance		Ixekizumab - Maintenance		Ustekinumab - Post Treatment Follow up		Ixekizumab - Post Treatment Follow up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/166 (33.1%)		40/135 (29.6%)		65/164 (39.6%)		50/131 (38.2%)		0/157 (0%)		0/60 (0%)
General disorders
Injection site erythema	0/166 (0%)	0	10/135 (7.4%)	15	0/164 (0%)	0	2/131 (1.5%)	4	0/157 (0%)	0	0/60 (0%)	0
Infections and infestations
Nasopharyngitis	34/166 (20.5%)	39	23/135 (17%)	27	40/164 (24.4%)	52	36/131 (27.5%)	47	0/157 (0%)	0	0/60 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	8/166 (4.8%)	8	3/135 (2.2%)	3	11/164 (6.7%)	16	8/131 (6.1%)	8	0/157 (0%)	0	0/60 (0%)	0
Back pain	4/166 (2.4%)	5	2/135 (1.5%)	2	9/164 (5.5%)	11	5/131 (3.8%)	5	0/157 (0%)	0	0/60 (0%)	0
Nervous system disorders
Headache	12/166 (7.2%)	17	7/135 (5.2%)	9	12/164 (7.3%)	19	10/131 (7.6%)	17	0/157 (0%)	0	0/60 (0%)	0
Vascular disorders
Hypertension	4/166 (2.4%)	4	2/135 (1.5%)	2	11/164 (6.7%)	11	4/131 (3.1%)	5	0/157 (0%)	0	0/60 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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