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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
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
Secondary ID [1] 0 0
I1F-MC-RHBP
Secondary ID [2] 0 0
15988
Universal Trial Number (UTN)
Trial acronym
IXORA-P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque 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: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving sPGA (0)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving PASI 90
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving PASI 100
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Change From Baseline in PASI
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Percent Improvement in PASI
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Mean Change From Baseline in Palmoplantar PASI (PPASI)
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) =4 Point Reduction From Baseline
Timepoint [10] 0 0
Baseline, Week 52
Secondary outcome [11] 0 0
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Change From Baseline in DLQI Total Score
Timepoint [12] 0 0
Baseline, Week 52
Secondary outcome [13] 0 0
Change From Baseline in Itch NRS Score
Timepoint [13] 0 0
Baseline, Week 52
Secondary outcome [14] 0 0
Change From Baseline in Skin Pain Visual Analog Scale (VAS)
Timepoint [14] 0 0
Baseline, Week 52
Secondary outcome [15] 0 0
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
Timepoint [15] 0 0
Baseline, Week 52
Secondary outcome [16] 0 0
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Timepoint [16] 0 0
Predose, Week 4, 12, 24, 36 and 52 Post dose
Secondary outcome [17] 0 0
Number of Participants With Anti-Ixekizumab Antibodies
Timepoint [17] 0 0
Baseline through Week 52

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2017
Sample size
Target
Accrual to date
Final
1257
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. - Benowa
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. - Fremantle
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
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
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment postcode(s) [5] 0 0
02606 - Phillip
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
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Kansas
Country [9] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Missouri
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Canada
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Barrie
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Canada
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Calgary
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Canada
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Halifax
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Hamilton
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London
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Markham
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Montreal
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Oakville
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Peterborough
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Richmond Hill
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Praha
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Kiel
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Germany
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Mahlow
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Munster
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Oroshaza
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Szolnok
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Tsu
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Pusan
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Seongnam
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Seoul
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Mexicali
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Mexico City
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Morelia
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Poland
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Bialystok
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Gdansk
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Kielce
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Krakow
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Wroclaw
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Caguas
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Carolina
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Ponce
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Romania
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Constanta
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Craiova
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Taiwan
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Tainan
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Taiwan
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Taipei

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?

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