Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02513550
Registration number
NCT02513550
Ethics application status
Date submitted
30/07/2015
Date registered
31/07/2015
Titles & IDs
Public title
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Query!
Scientific title
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
Query!
Secondary ID [1]
0
0
I1F-MC-RHBP
Query!
Secondary ID [2]
0
0
15988
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
IXORA-P
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ixekizumab
Treatment: Drugs - Placebo
Experimental: 80 mg Ixekizumab Q2W - 160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52. Placebo administered SQ, Q2W to maintain blind.
Experimental: 80 mg Ixekizumab Q4W - 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
Experimental: 80 mg Ixekizumab Q4W/Q2W - 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Experimental: 80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort - 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Experimental: 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort - 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
Experimental: 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort - 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Treatment: Drugs: Ixekizumab
Administered SQ
Treatment: Drugs: Placebo
Administered SQ
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Query!
Assessment method [1]
0
0
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Query!
Timepoint [1]
0
0
Week 52
Query!
Primary outcome [2]
0
0
Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Query!
Assessment method [2]
0
0
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
Query!
Timepoint [2]
0
0
Week 52
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving sPGA (0)
Query!
Assessment method [1]
0
0
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Query!
Timepoint [1]
0
0
Week 52
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving PASI 90
Query!
Assessment method [2]
0
0
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Query!
Timepoint [2]
0
0
Week 52
Query!
Secondary outcome [3]
0
0
Percentage of Participants Achieving PASI 100
Query!
Assessment method [3]
0
0
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Query!
Timepoint [3]
0
0
Week 52
Query!
Secondary outcome [4]
0
0
Change From Baseline in PASI
Query!
Assessment method [4]
0
0
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [4]
0
0
Baseline, Week 52
Query!
Secondary outcome [5]
0
0
Percent Improvement in PASI
Query!
Assessment method [5]
0
0
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [5]
0
0
Baseline, Week 52
Query!
Secondary outcome [6]
0
0
Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
Query!
Assessment method [6]
0
0
The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [6]
0
0
Baseline, Week 52
Query!
Secondary outcome [7]
0
0
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Query!
Assessment method [7]
0
0
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [7]
0
0
Baseline, Week 52
Query!
Secondary outcome [8]
0
0
Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
Query!
Assessment method [8]
0
0
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [8]
0
0
Baseline, Week 52
Query!
Secondary outcome [9]
0
0
Mean Change From Baseline in Palmoplantar PASI (PPASI)
Query!
Assessment method [9]
0
0
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [9]
0
0
Baseline, Week 52
Query!
Secondary outcome [10]
0
0
Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) =4 Point Reduction From Baseline
Query!
Assessment method [10]
0
0
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Query!
Timepoint [10]
0
0
Baseline, Week 52
Query!
Secondary outcome [11]
0
0
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
Query!
Assessment method [11]
0
0
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Query!
Timepoint [11]
0
0
Week 52
Query!
Secondary outcome [12]
0
0
Change From Baseline in DLQI Total Score
Query!
Assessment method [12]
0
0
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [12]
0
0
Baseline, Week 52
Query!
Secondary outcome [13]
0
0
Change From Baseline in Itch NRS Score
Query!
Assessment method [13]
0
0
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [13]
0
0
Baseline, Week 52
Query!
Secondary outcome [14]
0
0
Change From Baseline in Skin Pain Visual Analog Scale (VAS)
Query!
Assessment method [14]
0
0
The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [14]
0
0
Baseline, Week 52
Query!
Secondary outcome [15]
0
0
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
Query!
Assessment method [15]
0
0
EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Query!
Timepoint [15]
0
0
Baseline, Week 52
Query!
Secondary outcome [16]
0
0
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Query!
Assessment method [16]
0
0
Trough concentrations at steady state of Ixekizumab were evaluated.
Query!
Timepoint [16]
0
0
Predose, Week 4, 12, 24, 36 and 52 Post dose
Query!
Secondary outcome [17]
0
0
Number of Participants With Anti-Ixekizumab Antibodies
Query!
Assessment method [17]
0
0
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
Query!
Timepoint [17]
0
0
Baseline through Week 52
Query!
Eligibility
Key inclusion criteria
* Present with chronic plaque psoriasis for at least 6 months prior to enrollment
* At least 10% BSA of psoriasis at screening and at enrollment
* sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
* Candidates for phototherapy and/or systemic therapy
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
* Concurrent or recent use of any biologic agent
* Have participated in any study with ixekizumab
* Received a live vaccination within 12 weeks prior to enrollment
* Serious disorder or illness other than psoriasis
* Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
* Major surgery within 8 weeks of baseline, or will require surgery during the study
* Breastfeeding or nursing (lactating) women
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
3/08/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1257
Query!
Recruitment in Australia
Recruitment state(s)
Query!
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. - Benowa
Query!
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
Query!
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
Query!
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. - Fremantle
Query!
Recruitment hospital [5]
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. - Phillip
Query!
Recruitment hospital [6]
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
Query!
Recruitment postcode(s) [1]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [2]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [3]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [4]
0
0
6160 - Fremantle
Query!
Recruitment postcode(s) [5]
0
0
02606 - Phillip
Query!
Recruitment postcode(s) [6]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Hampshire
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Mexico
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oklahoma
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Rhode Island
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Tennessee
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Texas
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Utah
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Virginia
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Washington
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Mendoza
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Barrie
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Calgary
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Halifax
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Hamilton
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
London
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Markham
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Montreal
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Oakville
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Peterborough
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Quebec
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Richmond Hill
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Sherbrooke
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Surrey
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Waterloo
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Windsor
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Brno
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Novy Jicin
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Plzen-Bory
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Praha
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Berlin
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Darmstadt
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Kiel
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Mahlow
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Munster
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Budapest
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Debrecen
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Oroshaza
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Szolnok
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Osaka
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Takaoka
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Tsu
Query!
Country [63]
0
0
Korea, Republic of
Query!
State/province [63]
0
0
Bucheon
Query!
Country [64]
0
0
Korea, Republic of
Query!
State/province [64]
0
0
Pusan
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Seongnam
Query!
Country [66]
0
0
Korea, Republic of
Query!
State/province [66]
0
0
Seoul
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Mexicali
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Mexico City
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Monterrey
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
Morelia
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Bialystok
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Gdansk
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Kielce
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Krakow
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Lodz
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Swidnik
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Szczecin
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Wroclaw
Query!
Country [79]
0
0
Puerto Rico
Query!
State/province [79]
0
0
Caguas
Query!
Country [80]
0
0
Puerto Rico
Query!
State/province [80]
0
0
Carolina
Query!
Country [81]
0
0
Puerto Rico
Query!
State/province [81]
0
0
Ponce
Query!
Country [82]
0
0
Puerto Rico
Query!
State/province [82]
0
0
San Juan
Query!
Country [83]
0
0
Romania
Query!
State/province [83]
0
0
Bucuresti
Query!
Country [84]
0
0
Romania
Query!
State/province [84]
0
0
Cluj Napoca
Query!
Country [85]
0
0
Romania
Query!
State/province [85]
0
0
Constanta
Query!
Country [86]
0
0
Romania
Query!
State/province [86]
0
0
Craiova
Query!
Country [87]
0
0
Taiwan
Query!
State/province [87]
0
0
Tainan
Query!
Country [88]
0
0
Taiwan
Query!
State/province [88]
0
0
Taipei
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02513550
Query!
Trial related presentations / publications
Query!
Public notes
Query!
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02513550