Study of Ixekizumab (LY2439821) in Children 6 to Less Tha... | NCT03073200 | Trialant
NCT03073200
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 27, 2021Actual
Enrollment
201Actual
Phase
Phase 3
Conditions
Plaque Psoriasis
Interventions
Ixekizumab
Placebo
Etanercept
Countries
United States
Argentina
Canada
Czechia
France
Germany
Hungary
Mexico
Netherlands
Poland
Puerto Rico
Russia
Spain
Protocol Section
Identification Module
NCT ID
NCT03073200
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16367
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHCD
Other Identifier
Eli Lilly and Company
2016-003331-38
EudraCT Number
Brief Title
Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Official Title
Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis
Acronym
Ixora-peds
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 16, 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
Mar 28, 2017Actual
Primary Completion Date
Feb 7, 2019Actual
Completion Date
Mar 23, 2021Actual
First Submitted Date
Mar 3, 2017
First Submission Date that Met QC Criteria
Mar 3, 2017
First Posted Date
Mar 8, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 6, 2020
Results First Submitted that Met QC Criteria
Mar 6, 2020
Results First Posted Date
Mar 17, 2020Actual
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
Aug 30, 2021
Last Update Posted Date
Sep 27, 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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Plaque Psoriasis
Keywords
children
psoriasis treatment
adolescents
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
201Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ixekizumab
Experimental
Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.
Drug: Ixekizumab
Placebo
Placebo Comparator
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
Drug: Placebo
Open-Label Etanercept
Experimental
Etanercept given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period. Participants will only be randomized to etanercept in countries where it is approved for severe pediatric psoriasis treatment.
Drug: Etanercept
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
Ixekizumab
LY2439821
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.
Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.
Have Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician Global Assessment (sPGA) ≥3 and body surface area involvement ≥10% at screening and baseline.
Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.
Male subjects agree to use a reliable method of birth control during the study.
Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.
Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.
All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the American Academy of Paediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.
Exclusion Criteria:
Have pustular, erythrodermic, and/or guttate forms of psoriasis.
Have drug-induced psoriasis.
Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).
Participants with a documented history of immune deficiency syndrome.
Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.
Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy.
Have used any therapeutic agent targeted at reducing interleukin-17.
Have received other therapies within the specified time frames prior to screening (see below):
adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives.
systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy [psoralen plus ultraviolet A]) in the previous 4 weeks.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Years
Maximum Age
17 Years
Standard Ages
Child
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)
Paller AS, Seyger MMB, Magarinos GA, Pinter A, Cather JC, Rodriguez-Capriles C, Zhu D, Somani N, Garrelts A, Papp KA; IXORA-PEDS Investigators. Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis: The IXORA-PEDS Randomized Clinical Trial. JAMA Dermatol. 2022 May 1;158(5):533-541. doi: 10.1001/jamadermatol.2022.0655.
See Also Links
Label
URL
Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
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.
The 48-Week Double-Blind, Randomized Withdrawal Period occurs from Week 60 to Week 108 for participants in the Europe who meet the response criterion at Week 60 (defined as sPGA [0,1]).
Recruitment Details
Double-Blind Treatment Period (Week 0 to Week 12), Open-Label Maintenance Period (Week 12 to Week 60), Extension Period (Week 60 to Week 108) followed by post-treatment follow-up period occurring from last treatment visit (week 108), or Early Termination Visit (ETV) for up to 24 weeks following that visit.
Etanercept (ETN) is reference control group occurred only in Etanercept approved countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PBO (Double-Blinded Treatment Period)
Participants received matching placebo (PBO) for Ixekizumab (IXE) by subcutaneous injection.
FG001
IXEQ4W (Double-Blinded Treatment Period)
Periods
Title
Milestones
Reasons Not Completed
Double Blind Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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: RHCD 05 Protocol (b)_Redacted
Sep 22, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
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
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Placebo
Drug
Administered SC
Placebo
Etanercept
Drug
Administered SC
Open-Label Etanercept
Week 12
Percentage of Participants With a sPGA (0)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis.
Week 12
Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.
Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Week 12
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Week 4
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
Week 4
Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4
Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing "no itching" and 10 representing "worst itch imaginable.
Week 12
Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)
DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms & feelings, daily activities, leisure, work & school , personal relationships, & treatment. The recall period of this scale is over the "last week." Response categories and corresponding scores are:
Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).
Week 12
Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)
NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis & nail matrix psoriasis by area of involvement in the nail unit. Both fingernail & toenail involvement were assessed.The nail is divided with imaginary horizontal & longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) & nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed & nail matrix psoriasis in each quadrant:
0 = None
= present in one quadrant of nail
= present in two quadrants of nail
= present in three quadrants of nail
= present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed & nail matrix from each quadrant (maximum of 8). Each nail is evaluated, & the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)
Baseline, Week 12
Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)
The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows:
Erythema, Induration and Desquamation:
0 = Absent
= Slight
= Moderate
= Severe
= Severest Possible
Percent of Scalp Involved:
= <10%
= 10% - 29%
= 30% - 49%
= 50% - 69%
= 70% - 89%
= 90% - 100%
The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease).
LSMean was calculated using treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
Baseline, Week 12
Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)
PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms & soles on each hand & foot was assessed for erythema, induration, desquamation & percentage of area affected as follows:
0 = None, 1 = <10%, 2 = 10% - 29%, 3 = 30% - 49%, 4 = 50% - 69%, 5 = 70% - 89%, 6 = 90% - 100% PPASI score is a composite score derived from the sum scores for E, I, & D multiplied by a score for the extent of palm & sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease).
Baseline, Week 12
Number of Participants With Anti-Ixekizumab Antibodies
A treatment emergent - antidrug antibody (TE-ADA) positive participant were defined as:
a participant with a >= 4-fold increase over a positive baseline antibody titer; or
for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10.
Baseline through Week 48
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss).
Week 12
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.
Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
Week 12
Fountain Valley
California
92708
United States
Children's National Medical Center
Washington D.C.
District of Columbia
20010
United States
Olympian Clinical Research
Clearwater
Florida
33756
United States
Solutions Through Advanced Research, Inc.
Jacksonville
Florida
32256
United States
University of South Florida
Tampa
Florida
33612
United States
Forward Clinical Trials, Inc
Tampa
Florida
33624
United States
Advanced Medical Research
Sandy Springs
Georgia
30328
United States
Northwestern University
Chicago
Illinois
60611
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
Arlington Dermatology
Rolling Meadows
Illinois
60008
United States
The South Bend Clinic
South Bend
Indiana
46617
United States
University of Missouri
Columbia
Missouri
65212
United States
SSM Health Cardinal Glennon Children's Hospital
St Louis
Missouri
63104
United States
Psoriasis Treatment Center of Central New Jersey
East Windsor
New Jersey
08520
United States
University of North Carolina Dermatology and skin Cancer Cen
Chapel Hill
North Carolina
27516
United States
Wright State Physicians Dermatology
Fairborn
Ohio
45324
United States
Ohio State Univ College Of Medicine
Gahanna
Ohio
43230
United States
Oregon Dermatology and Research Center
Portland
Oregon
97210
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
Dermatology and Skin Surgery Center
Exton
Pennsylvania
19341
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Modern Research Associates PLLC
Dallas
Texas
75231
United States
Texas Dermatology and Laser Specialists
San Antonio
Texas
78218
United States
Virginia Clinical Research
Norfolk
Virginia
23502
United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autonoma de Buenos Aire
Buenos Aires
C1056ABJ
Argentina
Fundación Estudios ClÃnicos- Servicio de DermatologÃa
Participants with >50 kilogram (kg) weight received 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
FG002
ETN (Double-Blinded Treatment Period)
Participants received 0.8 milligrams per kilogram (mg/kg) Etanercept (ETN) not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
FG003
PBO/IXEQ4W (Maintenance Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
FG004
IXEQ4W/IXEQ4W (Maintenance Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
FG005
ETN/IXEQ4W (Maintenance Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
FG006
PBO/IXEQ4W/IXEQ4W (Extension Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
FG007
IXEQ4W/IXEQ4W/IXEQ4W (Extension Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
FG008
ETN/IXEQ4W/IXEQ4W (Extension Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
FG009
PBO (Randomized Withdrawal Period)
Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.
FG010
IXEQ4W (Randomized Withdrawal Period)
Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.
FG011
IXEQ4W_Re-Treatment (Randomized Withdrawal) Period
Participants from EU countries who do not meet the response criterion at Week 60 continued with open-label treatment with ixekizumab.
FG012
PBO (Post-Treatment Follow-Up)
Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
FG013
IXEQ4W (Post-Treatment Follow-Up)
Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
FG014
ETN (Post-Treatment Follow-Up)
Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
FG00056 subjects
FG001115 subjects
FG00230 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Participants in Etanercept Approved Countries
FG00019 subjects
FG00138 subjects
FG00230 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG00054 subjects
FG001114 subjects
FG00230 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Withdrawal by Parent/Guardian
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Open-Label 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.
FG00353 subjectsThis period is to report Maintenance Period participants.
FG004113 subjectsThis period is to report Maintenance Period participants.
FG00528 subjectsThis period is to report Maintenance Period participants.
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00349 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsThis period is to report Extension Period participants.
FG0040 subjectsThis period is to report Extension Period participants.
FG0050 subjectsThis period is to report Extension Period participants.
FG00634 subjectsThis period is to report Extension Period participants.
FG00768 subjectsThis period is to report Extension Period participants.
FG0089 subjectsThis period is to report Extension Period participants.
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 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
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Randomized Withdrawal Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjectsThis period is to report randomized withdrawal period participants.
FG0070 subjectsThis period is to report randomized withdrawal period participants.
FG0080 subjectsThis period is to report randomized withdrawal period participants.
FG00933 subjectsThis period is to report randomized withdrawal period participants.
FG01034 subjectsThis period is to report randomized withdrawal period participants.
FG01133 subjectsThis period is to report randomized withdrawal period participants.
FG0120 subjects
FG0130 subjects
FG0140 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
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Post-Treatment Follow-Up 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 subjectsThis period is to report Follow-Up period participants.
FG0100 subjectsThis period is to report Follow-Up period participants.
FG0110 subjectsThis period is to report Follow-Up period participants.
FG0126 subjectsThis period is to report Follow-Up period participants.
FG013166 subjectsThis period is to report Follow-Up period participants.
FG0142 subjectsThis period is to report 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
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
BG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
BG002
Open-label Etanercept
Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00056
BG001115
BG00230
BG003201
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
BG00013.1± 2.79
BG00113.7± 3.14
BG00213.7± 2.95
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00036
BG00163
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG00130
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0012
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Puerto Rico
Title
Measurements
BG0003
BG0015
BG002
Psoriasis Area Severity Index (PASI)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement).
Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Mean
Standard Deviation
Score on a scale
Title
Denominators
Categories
Title
Measurements
BG00019.73± 8.010
BG001
(sPGA)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5).
Mean
Standard Deviation
Score on a scale
Title
Denominators
Categories
Title
Measurements
BG0003.5± 0.63
BG001
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 ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.
Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
All randomized Participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Units
Counts
Participants
OG00056
OG001115
Title
Denominators
Categories
Title
Measurements
OG00025
OG00188.7
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
Fisher Exact
<0.001
Mean Difference (Final Values)
63.7
2-Sided
95
51.0
76.4
Superiority
Primary
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation(NRI).
Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants With a sPGA (0)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis.
All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.
Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.
Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4
Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing "no itching" and 10 representing "worst itch imaginable.
All randomized participants with baseline Itch NRS Score >=4 in placebo and Ixekizumab arms.
Missing values were imputed by NRI. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)
DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms & feelings, daily activities, leisure, work & school , personal relationships, & treatment. The recall period of this scale is over the "last week." Response categories and corresponding scores are:
Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).
All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
Secondary
Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)
NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis & nail matrix psoriasis by area of involvement in the nail unit. Both fingernail & toenail involvement were assessed.The nail is divided with imaginary horizontal & longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) & nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed & nail matrix psoriasis in each quadrant:
0 = None
= present in one quadrant of nail
= present in two quadrants of nail
= present in three quadrants of nail
= present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed & nail matrix from each quadrant (maximum of 8). Each nail is evaluated, & the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)
All randomized participants with baseline and post baseline NAPSI score in placebo and Ixekizumab arms.
Least squares(LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, region, baseline sPGA score,baseline weight category, baseline value, visit, treatment-by-visit, & baseline-by-visit interactions as fixed factors.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
Secondary
Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)
The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows:
Erythema, Induration and Desquamation:
0 = Absent
= Slight
= Moderate
= Severe
= Severest Possible
Percent of Scalp Involved:
= <10%
= 10% - 29%
= 30% - 49%
= 50% - 69%
= 70% - 89%
= 90% - 100%
The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease).
LSMean was calculated using treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
All randomized participants with baseline and post-baseline PSSI score in placebo and Ixekizumab.
LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)
PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms & soles on each hand & foot was assessed for erythema, induration, desquamation & percentage of area affected as follows:
0 = None, 1 = <10%, 2 = 10% - 29%, 3 = 30% - 49%, 4 = 50% - 69%, 5 = 70% - 89%, 6 = 90% - 100% PPASI score is a composite score derived from the sum scores for E, I, & D multiplied by a score for the extent of palm & sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease).
All randomized participants with baseline PPASI score in placebo and Ixekizumab arms.
LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Number of Participants With Anti-Ixekizumab Antibodies
A treatment emergent - antidrug antibody (TE-ADA) positive participant were defined as:
a participant with a >= 4-fold increase over a positive baseline antibody titer; or
for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10.
All randomized participants from maintenance period (During maintenance period participants were on Ixekizumab treatment).
Posted
Number
participants
Baseline through Week 48
ID
Title
Description
OG000
Ixekizumab (Maintenance Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Units
Counts
Participants
OG000
Secondary
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss).
All randomized participants in Ixekizumab arm with week 12 PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (μg/mL)
Week 12
ID
Title
Description
OG000
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.
Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Secondary
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation.
Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received matching placebo for Ixekizumab by subcutaneous injection.
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Time Frame
Up to 132 Weeks
Description
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been 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 (Double-Blinded Treatment Period)
Participants received matching placebo for Ixekizumab by subcutaneous injection.
0
56
0
56
14
56
EG001
IXEQ4W (Double-Blinded Treatment Period)
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
0
115
1
115
49
115
EG002
ETN (Double-Blinded Treatment Period)
Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
0
30
1
30
7
30
EG003
PBO/IXEQ4W (Maintenance Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
0
53
3
53
33
53
EG004
IXEQ4W/IXEQ4W (Maintenance Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
0
113
7
113
76
113
EG005
ETN/IXEQ4W (Maintenance Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
0
28
1
28
18
28
EG006
PBO/IXEQ4W/IXEQ4W (Extension Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
0
34
0
34
20
34
EG007
IXEQ4W/IXEQ4W/IXEQ4W (Extension Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
0
68
2
68
43
68
EG008
ETN/IXEQ4W/IXEQ4W (Extension Period)
Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
0
9
0
9
5
9
EG009
PBO (Randomized Withdrawal Period)
Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.
0
33
0
33
15
33
EG010
IXEQ4W (Randomized Withdrawal Period)
Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.
0
34
3
34
22
34
EG011
IXEQ4W_Re-Treatment (Randomized Withdrawal) Period
Participants from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab.
0
33
0
33
11
33
EG012
PBO (Post-Treatment Follow-Up)
Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
0
6
0
6
2
6
EG013
IXEQ4W (Post-Treatment Follow-Up)
Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
0
166
1
166
9
166
EG014
ETN (Post-Treatment Follow-Up)
Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
0
2
0
2
0
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Crohn's disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected53 at risk
EG0042 events2 affected113 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected34 at risk
EG0070 events0 affected68 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected33 at risk
EG0100 events0 affected34 at risk
EG0110 events0 affected33 at risk
EG0120 events0 affected6 at risk
EG0131 events1 affected166 at risk
EG0140 events0 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Inflammatory bowel disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Furuncle
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Herpes zoster oticus
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0021 events1 affected30 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Splenic rupture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Glucose tolerance decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected115 at risk
EG0020 events0 affected30 at risk
EG003
Astrocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Units
Counts
Participants
OG00056
OG001115
Title
Denominators
Categories
Title
Measurements
OG00023.2
OG00164.3
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
Fisher Exact
<0.001
Mean Difference (Final Values)
41.1
2-Sided
95
27.0
55.2
Superiority
OG001
Ixekizumab
Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
Units
Counts
Participants
OG00012
OG00134
Title
Denominators
Categories
Title
Measurements
OG0000.17± 5.331
OG001-16.87± 3.110
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
0.005
Mean Difference (Final Values)
-17.04
Standard Error of the Mean
5.747
2-Sided
95
-28.70
-5.38
Superiority
Units
Counts
Participants
OG00050
OG001102
Title
Denominators
Categories
Title
Measurements
OG000-12.28± 2.572
OG001-27.64± 2.320
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
Mean Difference (Final Values)
-15.36
Standard Error of the Mean
1.682
2-Sided
95
-18.69
-12.04
Superiority
Units
Counts
Participants
OG0009
OG00117
Title
Denominators
Categories
Title
Measurements
OG0006.89± 3.37
OG001-5.11± 2.148
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
0.006
Mean Difference (Final Values)
-12.01
Standard Deviation
3.853
2-Sided
95
-20.11
-3.90
Superiority
194
Title
Denominators
Categories
Title
Measurements
OG00056
111
Title
Denominators
Categories
Title
Measurements
OG0003.03± 106
OG002
Open-Label Etanercept
Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Units
Counts
Participants
OG00019
OG00138
OG00230
Title
Denominators
Categories
Title
Measurements
OG00026.3
OG00184.2
OG00263.3
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
OG001
OG002
Fisher Exact
0.089
Mean Difference (Final Values)
20.9
2-Sided
95
0.1
41.7
Superiority
OG002
Open-Label Etanercept
Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.