A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
IXORA-P
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
3 other identifiers
interventional
1,257
14 countries
125
Brief Summary
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2017
CompletedResults Posted
Study results publicly available
April 18, 2018
CompletedJune 17, 2020
June 1, 2020
1.3 years
July 30, 2015
November 20, 2017
June 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
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.
Week 52
Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
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.
Week 52
Secondary Outcomes (17)
Percentage of Participants Achieving sPGA (0)
Week 52
Percentage of Participants Achieving PASI 90
Week 52
Percentage of Participants Achieving PASI 100
Week 52
Change From Baseline in PASI
Baseline, Week 52
Percent Improvement in PASI
Baseline, Week 52
- +12 more secondary outcomes
Study Arms (6)
80 mg Ixekizumab Q2W
EXPERIMENTAL160 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.
80 mg Ixekizumab Q4W
EXPERIMENTAL160 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.
80 mg Ixekizumab Q4W/Q2W
EXPERIMENTAL160 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.
80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort
EXPERIMENTAL160 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.
80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
EXPERIMENTAL160 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.
80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
EXPERIMENTAL160 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.
Interventions
Administered SQ
Administered SQ
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (125)
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, 35205, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
David Stoll, M.D.
Beverly Hills, California, 90212, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Center for Dermatology and Laser Surgery
Sacramento, California, 95819, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Cherry Creek Research, Inc
Denver, Colorado, 80209, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134, United States
Avail Clinical Research LLC
DeLand, Florida, 32720, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Ameriderm Research
Ormond Beach, Florida, 32174, United States
University of South Florida
Tampa, Florida, 33624, United States
Advanced Medical Research
Atlanta, Georgia, 30342, United States
University Dermatology
Darien, Illinois, 60561, United States
Deaconess Clinic Inc
Evansville, Indiana, 47714, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46256, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
Kansas City Dermatology, PA
Overland Park, Kansas, 66215, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Dermatology Specialist
Louisville, Kentucky, 40202, United States
Dr. Shondra Smith MD
Lake Charles, Louisiana, 70605, United States
DermAssociates, P.C.
Rockville, Maryland, 20850, United States
ActivMed Practices & Research, Inc
Beverly, Massachusetts, 01915, United States
Central Dermatology PC
St Louis, Missouri, 63117, United States
ActivMed Practices & Research, Inc
Newington, New Hampshire, 03801, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239, United States
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, 10029, United States
Skin Search of Rochester, Inc
Rochester, New York, 14623, United States
University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Wilmington Dermatology Center
Wilmington, North Carolina, 28405, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5055, United States
Healthcare Research Consultant
Tulsa, Oklahoma, 74135, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, 19341, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Wyomissing, Pennsylvania, 19610, United States
Yardley Dermatology
Yardley, Pennsylvania, 19067, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
The Skin Wellness Center PC
Knoxville, Tennessee, 37922, United States
Austin Dermatology Associates
Austin, Texas, 78705, United States
Menter Dermatology Research Institute
Dallas, Texas, 75246, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Center for Clinical Studies
Houston, Texas, 77065, United States
Pflugerville Dermatology Clinical Research Center
Pflugerville, Texas, 78660, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Virginia Clinical Research
Norfolk, Virginia, 23507, United States
Dermatology Associates
Seattle, Washington, 98101, United States
Multicare Health System
Tacoma, Washington, 98405, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
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Buenos Aires, C1425DKG, Argentina
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Mendoza, 5500, Argentina
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Benowa, 4217, Australia
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Carlton, 3053, Australia
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Darlinghurst, 2010, Australia
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Fremantle, 6160, Australia
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Phillip, 02606, Australia
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Woolloongabba, 4102, Australia
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Barrie, L4M 6L2, Canada
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Calgary, T2G 1B1, Canada
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Halifax, B3H1Z2, Canada
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Hamilton, L8N1V6, Canada
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London, N6A 3H7, Canada
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Markham, L3P1X2, Canada
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Montreal, H2K4L5, Canada
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Oakville, L6J7W5, Canada
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Peterborough, K9J 5K2, Canada
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Québec, G1V 4X7, Canada
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Richmond Hill, L4B 1A5, Canada
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Sherbrooke, J1J 2G2, Canada
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Surrey, V3V 0C6, Canada
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Waterloo, N2J 1C4, Canada
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Windsor, N8W 1E6, Canada
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Brno, 656 91, Czechia
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Nový Jičín, 741 01, Czechia
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Plzen-Bory, 305-99, Czechia
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Prague, 100 34, Czechia
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Berlin, 10789, Germany
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Darmstadt, 64283, Germany
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Kiel, 24148, Germany
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Mahlow, 15831, Germany
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Münster, 48159, Germany
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Budapest, 1238, Hungary
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Debrecen, 4032, Hungary
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Orosháza, 5901, Hungary
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Szolnok, 5000, Hungary
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Osaka, 545-8586, Japan
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Takaoka, 9330871, Japan
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Tsu, 514-8507, Japan
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Mexicali, 21100, Mexico
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Mexico City, 3100, Mexico
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Monterrey, 64060, Mexico
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Morelia, CP 58249, Mexico
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Bialystok, 15-351, Poland
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Gdansk, 80-546, Poland
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Kielce, 25-316, Poland
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Krakow, 30-438, Poland
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Lodz, 90-265, Poland
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Szczecin, 70-332, Poland
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Świdnik, 21-040, Poland
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Wroclaw, 51-318, Poland
Office of Dr. Samuel Sanchez PSC
Caguas, 00727, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, 00985, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, 00716, Puerto Rico
GCM Medical Group PSC
San Juan, 00909, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
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Bucharest, 011025, Romania
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Cluj-Napoca, 400006, Romania
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Constanța, 900125, Romania
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Craiova, 200642, Romania
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Bucheon-si, 420-717, South Korea
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Pusan, 602-739, South Korea
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Seongnam, 463-707, South Korea
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Seoul, 100799, South Korea
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Tainan, 70166, Taiwan
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Taipei, 10048, Taiwan
Related Links
MeSH Terms
Interventions
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
- GT60
- 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
July 30, 2015
First Posted
July 31, 2015
Study Start
August 1, 2015
Primary Completion
November 1, 2016
Study Completion
August 3, 2017
Last Updated
June 17, 2020
Results First Posted
April 18, 2018
Record last verified: 2020-06
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.