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A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)

Primary Purpose

Genital Psoriasis, Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ixekizumab

Placebo

About this trial

This is an interventional treatment trial for Genital Psoriasis focused on measuring genital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
Pregnant or breastfeeding (lactating) women.

Sites / Locations

Southern California Dermatology
Clinical Science Institute
Olympian Clinical Research
Advanced Medical Research
Dawes Fretzin Clinical Research
The South Bend Clinic
Tufts Medical Center
Oregon Medical Research Center
Clinical Partners LLC
Modern Research Associates PLLC
Menter Dermatology Research Institute
Pflugerville Dermatology Clinical Research Center
University of Utah
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 1-877-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.
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.
GCM Medical Group PSC
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ixekizumab

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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).

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)

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.

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.

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).

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.

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.

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.

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

Full Information

NCT ID

NCT02718898

First Posted

March 21, 2016

Last Updated

August 28, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02718898

Brief Title

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis

Acronym

IXORA-Q

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

February 22, 2017 (Actual)

Study Completion Date

February 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Genital Psoriasis, Psoriasis

Keywords

genital

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ixekizumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ixekizumab

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Number of Participants Achieving Overall sPGA (0,1)

Description

Time Frame

Week 12

Title

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)

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

Description

Time Frame

Week 12

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)

Description

Time Frame

Week 12

Title

Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)

Description

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.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items

Description

Time Frame

Baseline, Week 12

Title

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

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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. Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year. Pregnant or breastfeeding (lactating) women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Southern California Dermatology

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Clinical Science Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Olympian Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Advanced Medical Research

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Dawes Fretzin Clinical Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

The South Bend Clinic

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46617

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Oregon Medical Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Clinical Partners LLC

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Modern Research Associates PLLC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Menter Dermatology Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Pflugerville Dermatology Clinical Research Center

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

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.

City

Adelaide

ZIP/Postal Code

5073

Country

Australia

Facility Name

City

Carlton

ZIP/Postal Code

3053

Country

Australia

Facility Name

City

Darlinghurst

ZIP/Postal Code

2010

Country

Australia

Facility Name

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

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.

City

London

ZIP/Postal Code

N6A 3H7

Country

Canada

Facility Name

City

Markham

ZIP/Postal Code

L3P1X2

Country

Canada

Facility Name

City

Montreal

ZIP/Postal Code

H2K4L5

Country

Canada

Facility Name

City

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

City

Surrey

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

City

Bergen op Zoom

ZIP/Postal Code

4624 VT

Country

Netherlands

Facility Name

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

GCM Medical Group PSC

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Links:

URL

http://www.lillytrialguide.com/en-US/studies/genital-psoriasis/RHBQ#?postal=

Description

Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)

Learn more about this trial

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis

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