A Study of Ixekizumab (LY2439821) in Participants With Mo... | NCT02718898 | Trialant
NCT02718898
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 16, 2019Actual
Enrollment
149Actual
Phase
Phase 3
Conditions
Genital Psoriasis
Psoriasis
Interventions
Ixekizumab
Placebo
Countries
United States
Australia
Austria
Belgium
Canada
Netherlands
Puerto Rico
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT02718898
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16010
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBQ
Other Identifier
Eli Lilly and Company
2015-002628-14
EudraCT Number
Brief Title
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Official Title
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Acronym
IXORA-Q
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 2019
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 2016
Primary Completion Date
Feb 22, 2017Actual
Completion Date
Feb 21, 2018Actual
First Submitted Date
Mar 21, 2016
First Submission Date that Met QC Criteria
Mar 21, 2016
First Posted Date
Mar 24, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 17, 2018
Results First Submitted that Met QC Criteria
Mar 21, 2018
Results First Posted Date
Mar 23, 2018Actual
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 28, 2019
Last Update Posted Date
Sep 16, 2019Actual
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)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Genital Psoriasis
Psoriasis
Keywords
genital
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
149Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ixekizumab
Experimental
Blinded Treatment Period: 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10. At week 12, 80 mg ixekizumab and placebo given SC.
Open Label Period: 80 mg ixekizumab given SC every 4 weeks (Q4W) with an option for Q2W dosing starting at week 24, week 28 or week 40.
Drug: Ixekizumab
Drug: Placebo
Placebo
Placebo Comparator
Blinded Treatment Period: Placebo given SC at baseline followed by placebo given SC Q2W from week 2 to week 10. At week 12, 160 mg ixekizumab given SC.
Open Label Period: 80 mg ixekizumab given SC Q4W with an option for Q2W dosing starting at week 24, week 28 or week 40.
Drug: Ixekizumab
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
Ixekizumab
Placebo
LY2439821
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Achieving Overall sPGA (0,1)
The overall sPGA is the physician's global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.
Have moderate-to-severe psoriasis in the genital area at screening and baseline.
Have plaque psoriasis in a nongenital area at screening and baseline.
Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area.
Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.
Exclusion Criteria:
Pustular, erythrodermic, and/or guttate forms of psoriasis.
History of drug-induced psoriasis.
Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments).
Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action.
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study.
Are currently enrolled in any other clinical trial involving an investigational product.
Serious disorder or illness other than plaque psoriasis.
Active or history of malignant disease within 5 years prior to baseline.
Serious infection within the last 3 months.
Have received a live vaccine within 3 months of baseline or plan to do so during the study.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Southern California Dermatology
Santa Ana
California
92701
United States
Clinical Science Institute
References Module
Citations
Not provided
See Also Links
Label
URL
Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)
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.
12 week Blinded Treatment period, followed by 40 week Open Label Treatment Period, followed by 12 week Post treatment follow-up period.
ttt = treatment, Pt = Participant.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo - Blinded Treatment
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by Subcutaneous injection during blinded treatment period.
FG001
Ixekizumab 80mg Q2W - Blinded Treatment
Periods
Title
Milestones
Reasons Not Completed
Blinded 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: Protocol
Nov 14, 2015
Feb 15, 2018
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
Placebo
Drug
Administered SC
Ixekizumab
Placebo
Week 12
Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS)
GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity).
Week 12
Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2
The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always.
*The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire).
Week 12
Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)
GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity.
The GPSIS Sexual Activity Avoidance Subscale includes 2 items:
Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4)
Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment.
Response categories include:
0 = not at all; 1 = a little; 2 = a lot; 3 = very much; "not relevant" responses scored as "0" and total score range of 0 to 30; higher scores indicate poor quality of life.
Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Baseline, Week 12
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Baseline, Week 12
Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)
Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis "today" by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe).
Week 12
Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
SF-36 is a participant-reported outcome measure evaluating a 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.
Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.
Baseline, Week 12
Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
SF-36 is a participant-reported outcome measure evaluating a 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 MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.
Baseline, Week 12
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Baseline, Week 12
Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
Week 12
Santa Monica
California
90404
United States
Olympian Clinical Research
Tampa
Florida
33609
United States
Advanced Medical Research
Sandy Springs
Georgia
30328
United States
Dawes Fretzin Clinical Research
Indianapolis
Indiana
46256
United States
The South Bend Clinic
South Bend
Indiana
46617
United States
Tufts Medical Center
Boston
Massachusetts
02111
United States
Oregon Medical Research Center
Portland
Oregon
97223
United States
Clinical Partners LLC
Johnston
Rhode Island
02919
United States
Modern Research Associates PLLC
Dallas
Texas
75231
United States
Menter Dermatology Research Institute
Dallas
Texas
75246
United States
Pflugerville Dermatology Clinical Research Center
Pflugerville
Texas
78660
United States
University of Utah
Salt Lake City
Utah
84132
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Adelaide
5073
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Carlton
3053
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Darlinghurst
2010
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Woolloongabba
4102
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Graz
8036
Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vienna
1090
Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vienna
1130
Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brussels
1090
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brussels
1200
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ghent
9000
Belgium
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
London
N6A 3H7
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Markham
L3P1X2
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Montreal
H2K4L5
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Surrey
V3V 0C6
Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bergen op Zoom
4624 VT
Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Breda
4818 CK
Netherlands
GCM Medical Group PSC
San Juan
00909
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bursa
16059
Turkey (Türkiye)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gaziantep
27310
Turkey (Türkiye)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Istanbul
34093
Turkey (Türkiye)
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80mg Ixekizumab and placebo was given SC during blinded treatment period.
FG002
Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period
Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.
Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.
FG003
Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment
Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.
Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.
FG004
Placebo - Post Treatment Follow-up
Participants did not receive any study treatment during post treatment follow-up period.
FG005
Ixeqizumab 80mg Q4W - Post Treatment Follow-up Period
Participants did not receive any study treatment during post treatment follow-up period.
FG006
Ixekizumab 80mg Q2W - Post Treatment Follow-up
Participants did not receive any study treatment during post treatment follow-up period.
FG00074 subjects
FG00175 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00065 subjects
FG00174 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0009 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Open Label Treatment Period (OLTP)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00265 subjects
FG00374 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00262 subjects
FG00364 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG00310 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Post Treatment Follow-up Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjectsOne participant who discontinued from placebo blinded treatment had entered post-treatment follow-up
FG00578 subjects
FG00649 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
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 placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC.
BG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00074
BG00175
BG002149
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
BG00044.4± 12.55
BG00143.1± 12.95
BG00243.7± 12.72
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00014
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG00016
BG00113
BG002
sPGA of Genitalia
The Static Physician Global Assessment (sPGA) of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis is assessed as follows: 0 = clear,1 = minimal,2 = mild,3 = moderate,4 = severe,5 = very severe.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0003.5± 0.53
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
Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
All randomized participants.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Units
Counts
Participants
OG00074
OG00175
Title
Denominators
Categories
Title
Measurements
OG0006
OG00155
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)
33.80
2-Sided
95
12.39
92.23
Superiority
Secondary
Number of Participants Achieving Overall sPGA (0,1)
The overall sPGA is the physician's global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1.
All randomized participants.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Units
Counts
Participants
Secondary
Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS)
GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity).
All randomized participants with baseline GPSS Itch NRS Score >= 3.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Secondary
Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2
The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always.
*The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire).
All randomized participants with baseline GenPs-SFQ Item 2 Score >= 2.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Secondary
Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)
GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity.
The GPSIS Sexual Activity Avoidance Subscale includes 2 items:
Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4)
All randomized participants with baseline GPSIS sexual activity avoidance subscale score >= 3.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment.
Response categories include:
0 = not at all; 1 = a little; 2 = a lot; 3 = very much; "not relevant" responses scored as "0" and total score range of 0 to 30; higher scores indicate poor quality of life.
Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
All randomized participants with baseline and post baseline observation for DLQI.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Secondary
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
All randomized participants with baseline and post baseline observation for mGPASI.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Secondary
Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)
Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis "today" by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe).
All randomized participants with baseline PatGA-Genital score >= 2.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Units
Counts
Participants
Secondary
Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
SF-36 is a participant-reported outcome measure evaluating a 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.
Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.
All randomized participants with baseline and post baseline measurement for SF-36 PCS.
mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation , Participants who discontinued due to other reasons were imputed by their last observation.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Secondary
Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
SF-36 is a participant-reported outcome measure evaluating a 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 MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.
All randomized participants with baseline and post baseline measurement for SF-36 MCS.
mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Secondary
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
All randomized participants with baseline and post baseline observation for GPSS total or individual item scores.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Secondary
Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
All randomized participants who received at least one dose of study drug and either had baseline and at least 1 post-baseline evaluable samples or had no evaluable baseline and all negative post-baseline anti-drug antibody negative samples.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was by given subcutaneous injection.
OG001
Ixekizumab 80mg Q2W
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Time Frame
Up to 667 Days
Description
Gender specific events occurring only 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
Placebo - Blinded Treatment Period
Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by subcutaneous injection during blinded treatment period.
0
74
1
74
19
74
EG001
Ixekizumab 80 mg Q2W - Blinded Treatment Period
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
0
75
0
75
21
75
EG002
Placebo/Ixekizumab 80mg Q4W - Open Label Treatment Period
Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.
Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.
0
65
2
65
28
65
EG003
Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open Label Treatment
Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period.
Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.
0
74
5
74
27
74
EG004
Placebo - Post Treatment Follow-up
Participants did not receive any study treatment during post treatment follow-up period.
0
1
0
1
0
1
EG005
Ixeqizumab 80mg Q2W - Post Treatment Follow-up Period
Participants did not receive any study treatment during post treatment follow-up period.
0
49
2
49
1
49
EG006
Ixekizumab 80mg Q4W - Post Treatment Follow-up
Participants did not receive any study treatment during post treatment follow-up period.
0
78
1
78
0
78
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Colitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG0031 events1 affected74 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected78 at risk
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected65 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Extradural haematoma
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected65 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected49 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0004 events4 affected74 at risk
EG0012 events1 affected75 at risk
EG0020 events0 affected65 at risk
EG0030 events0 affected74 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected78 at risk
Injection site reaction
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0017 events5 affected75 at risk
EG00224 events10 affected65 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0004 events4 affected74 at risk
EG0012 events2 affected75 at risk
EG00213 events9 affected65 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0005 events5 affected74 at risk
EG00112 events12 affected75 at risk
EG00212 events10 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0022 events2 affected65 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0022 events1 affected16 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0006 events4 affected74 at risk
EG0013 events3 affected75 at risk
EG0022 events2 affected65 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected16 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected16 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0004 events4 affected74 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected65 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Disclosures are prohibited until after the sponsor discloses the primary and secondary publications of clinical trial data.
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.
Units
Counts
Participants
OG00071
OG00172
Title
Denominators
Categories
Title
Measurements
OG0000.687± 0.7998
OG0015.193± 0.7942
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
ANCOVA
<0.001
Mean Difference (Final Values)
4.506
Standard Error of the Mean
1.1339
2-Sided
95
2.264
6.748
Superiority
Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period.