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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02718898




Registration number
NCT02718898
Ethics application status
Date submitted
21/03/2016
Date registered
24/03/2016

Titles & IDs
Public title
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Scientific title
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Secondary ID [1] 0 0
I1F-MC-RHBQ
Secondary ID [2] 0 0
16010
Universal Trial Number (UTN)
Trial acronym
IXORA-Q
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genital Psoriasis 0 0
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ixekizumab
Treatment: Drugs - Placebo

Experimental: Ixekizumab - 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.

Placebo comparator: Placebo - 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.


Treatment: Drugs: Ixekizumab
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Number of Participants Achieving Overall sPGA (0,1)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
Timepoint [10] 0 0
Baseline, Week 12
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Week 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.
* Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
* Pregnant or breastfeeding (lactating) women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2018
Sample size
Target
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment hospital [4] 0 0
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
Recruitment postcode(s) [1] 0 0
5073 - Adelaide
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Austria
State/province [10] 0 0
Graz
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Canada
State/province [14] 0 0
London
Country [15] 0 0
Canada
State/province [15] 0 0
Markham
Country [16] 0 0
Canada
State/province [16] 0 0
Montreal
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
State/province [18] 0 0
Surrey
Country [19] 0 0
Netherlands
State/province [19] 0 0
Bergen op Zoom
Country [20] 0 0
Netherlands
State/province [20] 0 0
Breda
Country [21] 0 0
Puerto Rico
State/province [21] 0 0
San Juan
Country [22] 0 0
Turkey
State/province [22] 0 0
Bursa
Country [23] 0 0
Turkey
State/province [23] 0 0
Gaziantep
Country [24] 0 0
Turkey
State/province [24] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02718898