A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
IXORA-Q
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
3 other identifiers
interventional
149
7 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2016
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2018
CompletedResults Posted
Study results publicly available
March 23, 2018
CompletedSeptember 16, 2019
August 1, 2019
11 months
March 21, 2016
February 17, 2018
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (11)
Number of Participants Achieving Overall sPGA (0,1)
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)
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
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)
Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Baseline, Week 12
- +6 more secondary outcomes
Study Arms (2)
Ixekizumab
EXPERIMENTALBlinded 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.
Placebo
PLACEBO COMPARATORBlinded 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
- Pregnant or breastfeeding (lactating) women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Southern California Dermatology
Santa Ana, California, 92701, United States
Clinical Science Institute
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
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Darlinghurst, 2010, Australia
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Woolloongabba, 4102, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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London, N6A 3H7, Canada
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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
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Québec, G1V 4X7, Canada
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Surrey, V3V 0C6, Canada
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Bergen op Zoom, 4624 VT, Netherlands
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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)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2016
First Posted
March 24, 2016
Study Start
April 1, 2016
Primary Completion
February 22, 2017
Study Completion
February 21, 2018
Last Updated
September 16, 2019
Results First Posted
March 23, 2018
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.