A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
NCT ID: NCT03573323
Last Updated: 2020-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1027 participants
INTERVENTIONAL
2018-11-09
2020-01-08
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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Ixekizumab
A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20.
The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Ixekizumab
Administered SC
Guselkumab
During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16.
The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Guselkumab
Administered SC
Placebo
Administered SC
Interventions
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Ixekizumab
Administered SC
Guselkumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are a candidate for phototherapy and/or systemic therapy.
* Have both an Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) score ≥12 at screening and at baseline.
* Have ≥10% body surface area (BSA) involvement at screening and baseline.
* If a male, agree to use a reliable method of birth control during the study.
* If female, agree to use highly effective method of contraception.
Exclusion Criteria
* Have a history of drug-induced psoriasis.
* Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
* Use of tanning booths for at least 4 weeks before baseline.
* Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept \<28 days; infliximab, adalimumab, certolizumab pegol, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; secukinumab \<5 months; or any other biologic agent (e.g., ustekinumab) \<5 half lives.
* Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have received treatment with ixekizumab.
* Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
* Have had a live vaccination within 12 weeks of baseline.
* Have a known allergy or hypersensitivity to any biologic therapy.
* Have had any major surgery within 8 weeks of baseline.
* Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
* Are women who are pregnant, or who are lactating (breast-feeding).
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
University of Alabama at Birmingham
Birmingham, Alabama, United States
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States
Perseverance Research Center
Scottsdale, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
Wallace Medical Group, Inc.
Beverly Hills, California, United States
California Dermatology and Clinical Research Institute
Encinitas, California, United States
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Advanced Research Center
Los Alamitos, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Dermatology Clinical Trials
Newport Beach, California, United States
Quest Dermatology Research
Northridge, California, United States
Northern California Research Corporation
Sacramento, California, United States
Advanced Research Center
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Synergy Dermatology
San Francisco, California, United States
Southern California Dermatology
Santa Ana, California, United States
Mosaic Dermatology
Santa Monica, California, United States
Clinical Science Institute
Santa Monica, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
Care Access Research-Walnut Creek
Walnut Creek, California, United States
Dermatology Physicians of Connecticut
Shelton, Connecticut, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, United States
Olympian Clinical Research
Largo, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Miami Dermatology & Laser Research
Miami, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Sensible Healthcare
Ocoee, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
International Clinical Research
Sanford, Florida, United States
MOORE Clinical Research
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Atlanta Dermatology, Vein Research Center, PC
Alpharetta, Georgia, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Dermatology Institute of Dupage Medical Group
Wheaton, Illinois, United States
Qualmedica Research LLC
Evansville, Indiana, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
Dermatology Specialists Research Indiana
New Albany, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Dermatology Specialist
Louisville, Kentucky, United States
Owensboro Dermatology Associates
Owensboro, Kentucky, United States
Lawrence J Green, M.D, LLC
Rockville, Maryland, United States
ActivMed Practices & Research, Inc
Beverly, Massachusetts, United States
Fivenson Dermatology
Ann Arbor, Michigan, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Clarkston Skin Research
Clarkston, Michigan, United States
Henry Ford Medical Center- New Center One
Detroit, Michigan, United States
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, United States
Central Dermatology PC
St Louis, Missouri, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
ActivMed Practices & Research, Inc
Portsmouth, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
Sadick Research Group
New York, New York, United States
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, United States
Dermatology Consulting Services
High Point, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Wright State Univ School of Medicine
Fairborn, Ohio, United States
Ohio State Univ College Of Medicine
Gahanna, Ohio, United States
Dermatologists of Southwest Ohio, Inc.
Mason, Ohio, United States
Oregon Medical Research Center
Portland, Oregon, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Yardley Dermatology
Yardley, Pennsylvania, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
International Clinical Research
Murfreesboro, Tennessee, United States
Arlington Research Center, Inc
Arlington, Texas, United States
Austin Institute for Clinical Research, Inc.
Austin, Texas, United States
Bellaire Dermatology
Bellaire, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Stephen L Miller, MD, PA
San Antonio, Texas, United States
University of Utah MidValley Dematology
Murray, Utah, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Virginia Dermatology & Skin Cancer Center
Norfolk, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
National Clinical Research - Richmond
Richmond, Virginia, United States
Dermatology Associates
Seattle, Washington, United States
West Virginia Research Institute
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Dermatology Research Institute Inc.
Calgary, Alberta, Canada
Kirk Barber Research
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
Karma Clinical Trials Inc
St. John's, Newfoundland and Labrador, Canada
Eastern Canada Cutaneous Research Assoicates Ltd
Halifax, Nova Scotia, Canada
Dermatrials Research Inc.
Hamilton, Ontario, Canada
Mediprobe Research Inc
London, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
DermEdge Research Inc
Mississauga, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada
Dr Isabelle Delorme Inc.
Drummondville, Quebec, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, Canada
Centro Reumatologico de Caguas
Caguas, PR, Puerto Rico
Office of Dr. Samuel Sanchez PSC
Caguas, PR, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
Mindful Medical Research
San Juan, PR, Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, , Puerto Rico
Countries
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References
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Armstrong A, Gonzalez-Cantero A, Khattri S, Muzy G, Malatestinic WN, Lampropoulou A, Feely M, See SK, Mert C, Blauvelt A. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies. Dermatol Ther (Heidelb). 2024 Apr;14(4):933-952. doi: 10.1007/s13555-024-01136-w. Epub 2024 Mar 23.
Gooderham M, Vender R, Crowley J, Hong HC, Feely M, Garrelts A, See K, Konicek B, Green L. Speed and Cumulative Responses According to Body Regions in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Ixekizumab (Interleukin-17A Antagonist) versus Guselkumab (Interleukin-23p19 Inhibitor). Dermatol Ther (Heidelb). 2024 Feb;14(2):441-451. doi: 10.1007/s13555-023-01075-y. Epub 2024 Feb 9.
Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
Blauvelt A, Leonardi C, Elewski B, Crowley JJ, Guenther LC, Gooderham M, Langley RG, Vender R, Pinter A, Griffiths CEM, Tada Y, Elmaraghy H, Lima RG, Gallo G, Renda L, Burge R, Park SY, Zhu B, Papp K; IXORA-R Study Group. A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial. Br J Dermatol. 2021 Jun;184(6):1047-1058. doi: 10.1111/bjd.19509. Epub 2020 Oct 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I1F-MC-RHCR
Identifier Type: OTHER
Identifier Source: secondary_id
17119
Identifier Type: -
Identifier Source: org_study_id
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