A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT02513550
Last Updated: 2020-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1257 participants
INTERVENTIONAL
2015-08-31
2017-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Ixekizumab
Administered SQ
Placebo
Administered SQ
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.
Ixekizumab
Administered SQ
Placebo
Administered SQ
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.
Ixekizumab
Administered SQ
Placebo
Administered SQ
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.
Ixekizumab
Administered SQ
Placebo
Administered SQ
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.
Ixekizumab
Administered SQ
Placebo
Administered SQ
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.
Ixekizumab
Administered SQ
Placebo
Administered SQ
Interventions
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Ixekizumab
Administered SQ
Placebo
Administered SQ
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
David Stoll, M.D.
Beverly Hills, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Center for Dermatology and Laser Surgery
Sacramento, California, United States
Medical Center for Clinical Research
San Diego, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Cherry Creek Research, Inc
Denver, Colorado, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, United States
Avail Clinical Research LLC
DeLand, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Ameriderm Research
Ormond Beach, Florida, United States
University of South Florida
Tampa, Florida, United States
Advanced Medical Research
Atlanta, Georgia, United States
University Dermatology
Darien, Illinois, United States
Deaconess Clinic Inc
Evansville, Indiana, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Dermatology Specialist
Louisville, Kentucky, United States
Dr. Shondra Smith MD
Lake Charles, Louisiana, United States
DermAssociates, P.C.
Rockville, Maryland, United States
ActivMed Practices & Research, Inc
Beverly, Massachusetts, United States
Central Dermatology PC
St Louis, Missouri, United States
ActivMed Practices & Research, Inc
Newington, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, United States
Skin Search of Rochester, Inc
Rochester, New York, United States
University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Piedmont Medical Research
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Healthcare Research Consultant
Tulsa, Oklahoma, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Wyomissing, Pennsylvania, United States
Yardley Dermatology
Yardley, Pennsylvania, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, United States
The Skin Wellness Center PC
Knoxville, Tennessee, United States
Austin Dermatology Associates
Austin, Texas, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Pflugerville Dermatology Clinical Research Center
Pflugerville, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Dermatology Associates
Seattle, Washington, United States
Multicare Health System
Tacoma, Washington, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
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Buenos Aires, , Argentina
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Mendoza, , Argentina
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Benowa, , Australia
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Carlton, , Australia
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Darlinghurst, , Australia
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Fremantle, , Australia
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Phillip, , Australia
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Woolloongabba, , Australia
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Barrie, , Canada
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Calgary, , Canada
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Halifax, , Canada
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Hamilton, , Canada
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London, , Canada
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Markham, , Canada
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Montreal, , Canada
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Oakville, , Canada
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Peterborough, , Canada
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Québec, , Canada
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Richmond Hill, , Canada
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Sherbrooke, , Canada
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Surrey, , Canada
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Waterloo, , Canada
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Windsor, , Canada
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Brno, , Czechia
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Nový Jičín, , Czechia
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Plzen-Bory, , Czechia
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Prague, , Czechia
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Berlin, , Germany
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Darmstadt, , Germany
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Kiel, , Germany
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Mahlow, , Germany
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Münster, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Orosháza, , Hungary
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Szolnok, , Hungary
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Osaka, , Japan
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Takaoka, , Japan
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Tsu, , Japan
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Mexicali, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Bialystok, , Poland
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Gdansk, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Szczecin, , Poland
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Świdnik, , Poland
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Wroclaw, , Poland
Office of Dr. Samuel Sanchez PSC
Caguas, , Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, , Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, , Puerto Rico
GCM Medical Group PSC
San Juan, , Puerto Rico
Mindful Medical Research
San Juan, , Puerto Rico
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
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Craiova, , Romania
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Bucheon-si, , South Korea
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Pusan, , South Korea
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Seongnam, , South Korea
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Seoul, , South Korea
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Tainan City, , Taiwan
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Taipei, , Taiwan
Countries
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Related Links
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Click here for more information about this study: A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Other Identifiers
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I1F-MC-RHBP
Identifier Type: OTHER
Identifier Source: secondary_id
2015-000190-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15988
Identifier Type: -
Identifier Source: org_study_id
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