A Study of Ixekizumab (LY2439821) in Chinese Participants... | NCT03364309 | Trialant
NCT03364309
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 25, 2021Actual
Enrollment
438Actual
Phase
Phase 3
Conditions
Plaque Psoriasis
Interventions
Ixekizumab
Placebo
Countries
China
Protocol Section
Identification Module
NCT ID
NCT03364309
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14438
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBH
Other Identifier
Eli Lilly and Company
Brief Title
A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Official Title
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 1, 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 26, 2018Actual
Primary Completion Date
Jun 4, 2020Actual
Completion Date
Jun 4, 2020Actual
First Submitted Date
Nov 9, 2017
First Submission Date that Met QC Criteria
Nov 30, 2017
First Posted Date
Dec 6, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jun 3, 2021
Results First Submitted that Met QC Criteria
Jun 3, 2021
Results First Posted Date
Jun 25, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 3, 2021
Last Update Posted Date
Jun 25, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.
Detailed Description
Study I1F-MC-RHBH is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis (Ps) during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, 48-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse or rebound following treatment withdrawal, and response to retreatment following relapse.
Conditions Module
Conditions
Plaque Psoriasis
Keywords
plaque psoriasis
ixekizumab
skin condition
skin disease
itching
psoriasis vulgaris
immune-mediated systemic disease
skin lesions
scaly patches
papules
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
438Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ixekizumab 80mg Q4W
Experimental
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period.
Drug: Ixekizumab
Ixekizumab 80mg Q2W
Experimental
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period.
Drug: Ixekizumab
Drug: Placebo
Placebo
Placebo Comparator
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
Ixekizumab 80mg Q2W
Ixekizumab 80mg Q4W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
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.
Week 12
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
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).
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline.
Have ≥10% BSA involvement at screening and baseline.
Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.
Are candidates for phototherapy and/or systemic therapy.
Exclusion Criteria:
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
Drug-induced psoriasis.
Ongoing use of prohibited treatments.
Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor.
Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to baseline, whichever is longer.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
Gao X, Pan W, Zheng M, Li F, Dong X, Lv D, Guo Z, Li J, Wang X, Geng S. Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab. Adv Ther. 2025 Jan;42(1):334-347. doi: 10.1007/s12325-024-03030-5. Epub 2024 Nov 13.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Induction Dosing Period: Week 0 (baseline) to Week 12. Maintenance Dosing Period and Re-treatment (Maintenance) Period: Week 12 to Week 60.
Post-Treatment Follow-Up Period: Occurred from last treatment period visit or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.
Recruitment Details
Responders were defined as achieving an sPGA score of 0 or 1. Non-responders were defined as having an sPGA score of >1. Responders were monitored for relapse, relapse (loss of response) occurring after Week 12 (Visit 7) was defined as an sPGA score of ≥3. In Re-treatment (Maintenance) Period, participants who relapsed received continued treatment of ixekizumab 80 mg Q4W, regardless of their treatment assignment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PBO-Induction Dosing Period
Participants received placebo (PBO) every two weeks (Q2W) by subcutaneous (SC) injection during induction period.
FG001
IXE80Q4W-Induction Dosing Period
Periods
Title
Milestones
Reasons Not Completed
Induction Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 14, 2019
May 24, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
LY2439821
Placebo
Drug
Administered SC
Ixekizumab 80mg Q2W
Placebo
Week 12
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
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).
Week 12
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
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).
Week 12
Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4
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.
Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life.
Least Square Mean (LS Mean) was calculated using Mixed Model Repeated Measures (MMRM) model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement
NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis
The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.
LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline on Patient Global Assessment of Disease Severity
The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been.
LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Change From Baseline on the Joint Pain Visual Analog Scale (VAS)
The Joint Pain VAS is a participant-administered scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of a participant's joint pain from PsA is indicated by placing a single mark on the horizontal scale (0 = none; 100 = as severe as you can imagine). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 12
Percentage of Participants With Anti-Ixekizumab Antibodies
Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Baseline through Week 12
Beijing
Beijing Municipality
100191
China
Guangdong Province People's Hospital
Guangzhou
Guangdong
510080
China
The Second Xiangya Hospital of Central South University
Changsha
Hunan
410011
China
YanCheng First People's Hospital
Yancheng
Jiangsu
224005
China
The Second Hospital of Jilin University
Changchun
Jilin
130022
China
The First Hospital of China Medical University
Shenyang
Liaoning
110001
China
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Nanjing
210029
China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
710004
China
First Hospital of Shanxi Medical University
Taiyuan
Shanxi
030001
China
West China Hospital of Sichuan University
Chengdu
Sichuan
610041
China
Second Affiliate Hospital of Zhejiang Medical University
Hangzhou
Zhejiang
310009
China
Zhejiang Provincial People's Hospital
Hangzhou
Zhejiang
310014
China
Beijing Chao Yang Hospital
Beijing
100020
China
Peking University First Hospital
Beijing
100034
China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai
200025
China
Shanghai Dermatology Hospital
Shanghai
200443
China
Derived
Li X, Ding Y, Zhang C, Lu Y, Li F, Pan W, Guo S, Li J, Zhao B, Zheng J. Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Psoriasis and Special Body Area Involvement: Sub-analysis of a Randomized, Double-Blind, Multicenter Phase 3 Study. Adv Ther. 2025 Jan;42(1):146-163. doi: 10.1007/s12325-024-02976-w. Epub 2024 Sep 30.
Participants received starting dose of 160 milligrams (mg) Ixekizumab (IXE) at week 0 followed by 80mg Ixekizumab once every four weeks (80Q4W) by subcutaneous injection during induction period
FG002
IXE80Q2W-Induction Dosing Period
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (80Q2W) by subcutaneous injection during induction period
FG003
IXE80Q4W(Res)/PBO-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
FG004
IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
FG005
IXE80Q2W(Res)/PBO-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
FG006
IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
FG007
PBO(Res)/PBO-Maintenance Dosing Period
Participants who received placebo in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
FG008
PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period
Participants who received placebo in induction period and classified as Non-responders (NonResp) received Ixekizumab 80 mg Q4W by SC injection in maintenance dosing period.
FG009
IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q4W in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
FG010
IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q2W in induction period and classified as non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
FG011
PBO(Resp)/PBO-Re-treatment (Maintenance) Period
Participants who were classified as placebo responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
FG012
IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q4W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
FG013
IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q4W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
FG014
IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q2W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
FG015
IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q2W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
FG016
PBO-Follow-up Period
Participants did not receive any intervention in post treatment follow-up period
FG017
IXE80Q4W-Follow-up Period
Participants did not receive any intervention in post treatment follow-up period
FG018
IXE80Q2W-Follow-up Period
Participants did not receive any intervention in post treatment follow-up period
FG00088 subjects
FG001174 subjects
FG002176 subjects
FG0030 subjects
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FG0090 subjects
FG0100 subjects
FG0110 subjects
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FG0130 subjects
FG0140 subjects
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FG0180 subjects
Received at Least One Dose of Study Drug
FG00088 subjects
FG001174 subjects
FG002176 subjects
FG0030 subjects
FG0040 subjects
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FG0060 subjects
FG0070 subjects
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FG0090 subjects
FG0100 subjects
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COMPLETED
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NOT COMPLETED
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Type
Comment
Reasons
Adverse Event
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Withdrawal by Subject
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FG004
Lost to Follow-up
FG0001 subjects
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FG004
Physician Decision
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FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsThis period is to report Maintenance Period participants.
FG0010 subjectsThis period is to report Maintenance Period participants.
FG0020 subjectsThis period is to report Maintenance Period participants.
FG00347 subjectsThis period is to report Maintenance Period participants.
FG00492 subjectsThis period is to report Maintenance Period participants.
FG00550 subjectsThis period is to report Maintenance Period participants.
FG006100 subjectsThis period is to report Maintenance Period participants.
FG0073 subjectsThis period is to report Maintenance Period participants.
FG00879 subjectsThis period is to report Maintenance Period participants.
FG00931 subjectsThis period is to report Maintenance Period participants.
FG01023 subjectsThis period is to report Maintenance Period participants.
FG0110 subjects
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Received at Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00347 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00344 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Re-treatment (Maintenance) Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0040 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0050 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0060 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0070 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0080 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0090 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0100 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0112 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG01243 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0137 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG01445 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG01510 subjectsThis period is to report for Re-treatment (Maintenance) Period.
FG0160 subjects
FG0170 subjects
FG0180 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Post-Treatment Followup Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjectsThis period is to report for Follow-up Period participants.
FG0120 subjectsThis period is to report for Follow-up Period participants.
FG0130 subjectsThis period is to report for Follow-up Period participants.
FG0140 subjectsThis period is to report for Follow-up Period participants.
FG0150 subjectsThis period is to report for Follow-up Period participants.
FG01611 subjectsThis period is to report for Follow-up Period participants.
FG017375 subjectsThis period is to report for Follow-up Period participants.
FG0182 subjectsThis period is to report for Follow-up Period participants.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
BG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
BG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00088
BG001174
BG002176
BG003438
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.9± 12.38
BG00141.2± 11.59
BG00239.2± 10.53
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00145
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
China
Title
Measurements
BG00088
BG001174
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00088
OG001174
OG002176
Title
Denominators
Categories
Title
Measurements
OG0003.4(0.0 to 7.2)
OG00179.9(73.9 to 85.8)
OG00286.4(81.3 to 91.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.0001
Odds Ratio (OR)
99.99
2-Sided
95
33.57
99.99
Superiority
OG000
OG002
Regression, Logistic
<0.001
Primary
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
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).
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.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
Secondary
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Secondary
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
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).
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.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
Secondary
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
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).
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.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
Secondary
Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4
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.
All randomized participants who received at least one dose of study drug and had baseline who had baseline Itch NRS ≥4.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life.
Least Square Mean (LS Mean) was calculated using Mixed Model Repeated Measures (MMRM) model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had baseline and post baseline DLQI total score.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
Secondary
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement
NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had baseline fingernail involvement.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
Secondary
Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis
The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.
LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had postbaseline BSA involvement.
Posted
Least Squares Mean
Standard Error
Percent of BSA
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Secondary
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had baseline scalp involvement.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Secondary
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had post baseline SF-36 PCS score.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Secondary
Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had post baseline SF-36 MCS score.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Secondary
Change From Baseline on Patient Global Assessment of Disease Severity
The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been.
LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had postbaseline patient global assessment score.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Secondary
Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had baseline palmoplantar psoriasis involvement.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Secondary
Change From Baseline on the Joint Pain Visual Analog Scale (VAS)
The Joint Pain VAS is a participant-administered scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of a participant's joint pain from PsA is indicated by placing a single mark on the horizontal scale (0 = none; 100 = as severe as you can imagine). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants who received at least one dose of study drug and had baseline psoriatic arthritis.
Posted
Least Squares Mean
Standard Error
millimeter (mm)
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Secondary
Percentage of Participants With Anti-Ixekizumab Antibodies
Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
All randomized participants who received at least one dose of study drug.
Posted
Number
percentage of participants
Baseline through Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
OG001
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Time Frame
Up to 72 weeks
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PBO-Induction Dosing Period
Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
0
88
3
88
25
88
EG001
IXE80Q4W-Induction Dosing Period
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period
0
174
2
174
89
174
EG002
IXE80Q2W-Induction Dosing Period
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
0
176
1
176
97
176
EG003
IXE80Q4W(Res)/PBO-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
0
47
1
47
24
47
EG004
IXE80Q4W(Res)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q4W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
0
92
5
92
68
92
EG005
IXE80Q2W(Res)/PBO-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
0
50
1
50
22
50
EG006
IXE80Q2W(Res)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q2W in induction period and classified as responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
0
100
2
100
66
100
EG007
PBO(Res)/PBO-Maintenance Dosing Period
Participants who received placebo in induction period and classified as responders received placebo Q4W by SC injection in maintenance dosing period.
0
3
1
3
1
3
EG008
PBO(NonResp)/IXE80Q4W-Maintenance Dosing Period
Participants who received placebo in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
1
79
5
79
58
79
EG009
IXE80Q4W(NonResp)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q4W in induction period and classified as Non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
0
31
0
31
22
31
EG010
IXE80Q2W(NonResp)/IXE80Q4W-Maintenance Dosing Period
Participants who received Ixekizumab 80mg Q2W in induction period and classified as non-responders received Ixekizumab 80mg Q4W by SC injection in maintenance dosing period.
0
23
1
23
14
23
EG011
PBO(Resp)/PBO-Re-treatment (Maintenance) Period
Participants who were classified as placebo responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
0
2
0
2
1
2
EG012
IXE80Q4W(Resp)/PBO-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q4W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
0
43
1
43
24
43
EG013
IXE80Q4W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q4W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
0
7
0
7
4
7
EG014
IXE80Q2W(Resp)/PBO-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q2W responders and received PBO during maintenance dosing period and after relapse retreated with Ixekizumab 80mg Q4W by SC injection.
0
45
2
45
27
45
EG015
IXE80Q2W(Resp)/IXE80Q4W-Re-treatment (Maintenance) Period
Participants who were classified as Ixekizumab 80mg Q2W responders and received Ixekizumab 80mg Q4W during maintenance dosing period and after relapse received Ixekizumab 80mg Q4W by SC injection.
0
10
0
10
5
10
EG016
PBO-Follow-up Period
Participants did not receive any intervention in post treatment follow-up period
0
11
0
11
0
11
EG017
IXE80Q4W-Follow-up Period
Participants did not receive any intervention in post treatment follow-up period
0
375
7
375
27
375
EG018
IXE80Q2W-Follow-up Period
Participants did not receive any intervention in post treatment follow-up period
0
2
0
2
0
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG0030 events0 affected47 at risk
EG0040 events0 affected92 at risk
EG0050 events0 affected50 at risk
EG0060 events0 affected100 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected79 at risk
EG0090 events0 affected31 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected43 at risk
EG0130 events0 affected7 at risk
EG0141 events1 affected45 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected11 at risk
EG0170 events0 affected375 at risk
EG0180 events0 affected2 at risk
Anal fistula
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Jaw cyst
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Eyelid naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected88 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected176 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00088
OG001174
OG002176
Title
Denominators
Categories
Title
Measurements
OG0008.0(2.3 to 13.6)
OG00187.4(82.4 to 92.3)
OG00293.8(90.2 to 97.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
79.95
2-Sided
95
32.76
99.99
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
99.99
2-Sided
95
64.87
99.99
Superiority
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00088
OG001174
OG002176
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 0.0)
OG00135.6(28.5 to 42.7)
OG00236.4(29.3 to 43.5)
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00088
OG001174
OG002176
Title
Denominators
Categories
Title
Measurements
OG0002.3(0.0 to 5.4)
OG00175.9(69.5 to 82.2)
OG00282.4(76.8 to 88.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
99.99
2-Sided
95
31.88
99.99
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
99.99
2-Sided
95
46.96
99.99
Superiority
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00088
OG001174
OG002176
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 0.0)
OG00129.3(22.5 to 36.1)
OG00233.0(26.0 to 39.9)
Units
Counts
Participants
OG00062
OG001128
OG002125
Title
Denominators
Categories
Title
Measurements
OG0008.1(1.3 to 14.8)
OG00176.6(69.2 to 83.9)
OG00278.4(71.2 to 85.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
37.24
2-Sided
95
13.68
99.99
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
41.38
2-Sided
95
15.09
99.99
Superiority
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00082
OG001170
OG002175
Title
Denominators
Categories
Title
Measurements
OG0000.92± 0.495
OG001-8.60± 0.346
OG002-8.86± 0.343
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
LSMean Difference
-9.52
Standard Error of the Mean
0.604
2-Sided
95
-10.71
-8.33
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
-9.78
Standard Error of the Mean
0.603
2-Sided
95
-10.96
-8.59
Superiority
OG002
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00066
OG001132
OG002130
Title
Denominators
Categories
Title
Measurements
OG000-1.26± 1.365
OG001-11.35± 0.967
OG002-10.07± 0.974
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
LSMean Difference
-10.09
Standard Error of the Mean
1.673
2-Sided
95
-13.38
-6.79
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
-8.81
Standard Error of the Mean
1.677
2-Sided
95
-12.11
-5.51
Superiority
Units
Counts
Participants
OG00082
OG001170
OG002175
Title
Denominators
Categories
Title
Measurements
OG000-0.36± 1.660
OG001-35.32± 1.157
OG002-36.70± 1.146
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
LSMean Difference
-34.96
Standard Error of the Mean
2.023
2-Sided
95
-38.94
-30.98
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
-36.34
Standard Error of the Mean
2.018
2-Sided
95
-40.30
-32.37
Superiority
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00078
OG001166
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-1.59± 0.787
OG001-18.33± 0.544
OG002-19.52± 0.539
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
LSMean Difference
-16.74
Standard Error of the Mean
0.957
2-Sided
95
-18.62
-14.86
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
-17.93
Standard Error of the Mean
0.954
2-Sided
95
-19.80
-16.05
Superiority
Ixekizumab 80mg Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period
Units
Counts
Participants
OG00082
OG001170
OG002175
Title
Denominators
Categories
Title
Measurements
OG000-1.812± 0.5492
OG0014.417± 0.3815
OG0024.724± 0.3766
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
LSMean Difference
6.228
Standard Error of the Mean
0.6681
2-Sided
95
4.915
7.541
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
6.536
Standard Error of the Mean
0.6668
2-Sided
95
5.225
7.847
Superiority
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period