A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Registration Number
- NCT03573323
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1027
- Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
- 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.
- Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
- 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- Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Guselkumab Placebo 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. Ixekizumab 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. Guselkumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) Week 12 The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving PASI 100 Week 24 The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Percentage of Participants Achieving PASI 75 Week 2 The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Percentage of Participants Achieving PASI 90 Week 8 The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0) Week 12 The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.
Percentage of Participants Achieving PASI 50 Week 1 The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline.
Trial Locations
- Locations (120)
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, United States
Arlington Research Center, Inc
🇺🇸Arlington, Texas, United States
Dermatology Clinical Trials
🇺🇸Newport Beach, California, United States
Mindful Medical Research
🇵🇷San Juan, Puerto Rico
Suzanne Bruce and Associates, PA
🇺🇸Houston, Texas, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
University Clinical Trials, Inc.
🇺🇸San Diego, California, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Stephen L Miller, MD, PA
🇺🇸San Antonio, Texas, United States
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
Synergy Dermatology
🇺🇸San Francisco, California, United States
Dermatology Specialists Research Indiana
🇺🇸New Albany, Indiana, United States
Dermatology Physicians of Connecticut
🇺🇸Shelton, Connecticut, United States
Ohio State Univ College Of Medicine
🇺🇸Gahanna, Ohio, United States
Dermatology and Skin Surgery Center
🇺🇸Exton, Pennsylvania, United States
Wright State Univ School of Medicine
🇺🇸Fairborn, Ohio, United States
Stratica Medical
🇨🇦Edmonton, Alberta, Canada
Virginia Clinical Research
🇺🇸Norfolk, Virginia, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Bellaire Dermatology
🇺🇸Bellaire, Texas, United States
K. Papp Clinical Research Inc
🇨🇦Waterloo, Ontario, Canada
Modern Research Associates PLLC
🇺🇸Dallas, Texas, United States
DermEdge Research Inc
🇨🇦Mississauga, Ontario, Canada
Q&T Research Sherbrooke Inc
🇨🇦Sherbrooke, Quebec, Canada
University of Utah MidValley Dematology
🇺🇸Murray, Utah, United States
Dr Isabelle Delorme Inc.
🇨🇦Drummondville, Quebec, Canada
Dermatology Associates
🇺🇸Seattle, Washington, United States
Centro Reumatologico de Caguas
🇵🇷Caguas, Puerto Rico
Ponce School of Medicine CAIMED Center
🇵🇷Ponce, Puerto Rico
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
Enverus Medical Research
🇨🇦Surrey, British Columbia, Canada
Innovaderm Research Inc
🇨🇦Montreal, Quebec, Canada
Alliance Dermatology and Mohs Center
🇺🇸Phoenix, Arizona, United States
Henry Ford Medical Center- New Center One
🇺🇸Detroit, Michigan, United States
Kirk Barber Research
🇨🇦Calgary, Alberta, Canada
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
California Dermatology and Clinical Research Institute
🇺🇸Encinitas, California, United States
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
🇺🇸Fountain Valley, California, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
Wallace Medical Group, Inc.
🇺🇸Beverly Hills, California, United States
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
Total Skin and Beauty Dermatology Center PC
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Northern California Research Corporation
🇺🇸Sacramento, California, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Bakersfield Dermatology and Skin Cancer Medical Group
🇺🇸Bakersfield, California, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Advanced Research Center
🇺🇸San Diego, California, United States
Quest Dermatology Research
🇺🇸Northridge, 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
Care Access Research-Walnut Creek
🇺🇸Walnut Creek, California, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
Florida Academic Dermatology Centers
🇺🇸Coral Gables, 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
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Sensible Healthcare
🇺🇸Ocoee, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Atlanta Dermatology, Vein Research Center, PC
🇺🇸Alpharetta, Georgia, United States
MOORE Clinical Research
🇺🇸Tampa, Florida, United States
International Clinical Research
🇺🇸Murfreesboro, Tennessee, United States
Skin Care Physicians of Georgia
🇺🇸Macon, Georgia, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Dermatology Institute of Dupage Medical Group
🇺🇸Wheaton, Illinois, United States
Dawes Fretzin Clinical Research
🇺🇸Indianapolis, Indiana, United States
Qualmedica Research LLC
🇺🇸Evansville, Indiana, United States
The South Bend Clinic
🇺🇸South Bend, Indiana, United States
The Indiana Clinical Trials Center, PC
🇺🇸Plainfield, Indiana, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Owensboro Dermatology Associates
🇺🇸Owensboro, Kentucky, United States
ActivMed Practices & Research, Inc
🇺🇸Portsmouth, New Hampshire, United States
Lawrence J Green, M.D, LLC
🇺🇸Rockville, Maryland, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Clarkston Skin Research
🇺🇸Clarkston, Michigan, United States
St Joseph Dermatology and Vein Clinic
🇺🇸Saint Joseph, Michigan, 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
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Piedmont Plastic Surgery and Dermatology
🇺🇸Charlotte, North Carolina, United States
Central Dermatology PC
🇺🇸Saint Louis, Missouri, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Sadick Research Group
🇺🇸New York, New York, 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
Dermatologists of Southwest Ohio, Inc.
🇺🇸Mason, Ohio, United States
Yardley Dermatology
🇺🇸Yardley, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Virginia Dermatology & Skin Cancer Center
🇺🇸Norfolk, Virginia, United States
West Virginia Research Institute
🇺🇸Morgantown, West Virginia, United States
Dermatology Research Institute Inc.
🇨🇦Calgary, Alberta, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
Karma Clinical Trials Inc
🇨🇦St. John's, Newfoundland and Labrador, Canada
The Guenther Dermatology Research Centre
🇨🇦London, Ontario, Canada
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
Dermatrials Research Inc.
🇨🇦Hamilton, Ontario, Canada
Mediprobe Research Inc
🇨🇦London, Ontario, Canada
Eastern Canada Cutaneous Research Assoicates Ltd
🇨🇦Halifax, Nova Scotia, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Santa Cruz Behavioral PSC
🇵🇷Bayamón, Puerto Rico
Clinical Partners LLC
🇺🇸Johnston, Rhode Island, United States
Office of Dr. Samuel Sanchez PSC
🇵🇷Caguas, Puerto Rico
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Dr. Chih-ho Hong Medical Inc.
🇨🇦Surrey, British Columbia, Canada
Dermatology Specialist
🇺🇸Louisville, Kentucky, United States
Fivenson Dermatology
🇺🇸Ann Arbor, Michigan, United States
Clinical Research Center of the Carolinas
🇺🇸Charleston, South Carolina, United States
National Clinical Research - Richmond
🇺🇸Richmond, Virginia, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States