A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
IXORA-R
A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis
2 other identifiers
interventional
1,027
3 countries
124
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2018
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedStudy Start
First participant enrolled
November 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2020
CompletedResults Posted
Study results publicly available
July 28, 2020
CompletedJuly 28, 2020
February 1, 2020
8 months
June 20, 2018
July 10, 2020
July 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
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.
Week 12
Secondary Outcomes (8)
Percentage of Participants Achieving PASI 75
Week 2
Percentage of Participants Achieving PASI 90
Week 4
Percentage of Participants Achieving PASI 100
Week 4
Percentage of Participants Achieving PASI 90
Week 8
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)
Week 12
- +3 more secondary outcomes
Study Arms (2)
Ixekizumab
EXPERIMENTALA 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
EXPERIMENTALDuring 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (124)
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, 35205, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032, United States
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309, United States
Wallace Medical Group, Inc.
Beverly Hills, California, 90211, United States
California Dermatology and Clinical Research Institute
Encinitas, California, 92024, United States
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, 92708, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Advanced Research Center
Los Alamitos, California, 90720, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Dermatology Clinical Trials
Newport Beach, California, 92660, United States
Quest Dermatology Research
Northridge, California, 91324, United States
Northern California Research Corporation
Sacramento, California, 95821, United States
Advanced Research Center
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Synergy Dermatology
San Francisco, California, 94132, United States
Southern California Dermatology
Santa Ana, California, 92701, United States
Mosaic Dermatology
Santa Monica, California, 90403, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Unison Clinical Trials
Sherman Oaks, California, 91403, United States
Care Access Research-Walnut Creek
Walnut Creek, California, 94598, United States
Dermatology Physicians of Connecticut
Shelton, Connecticut, 06484, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Miami Dermatology & Laser Research
Miami, Florida, 33173, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
International Clinical Research
Sanford, Florida, 32771, United States
MOORE Clinical Research
Tampa, Florida, 33609, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Olympian Clinical Research
Tampa, Florida, 33614, United States
Atlanta Dermatology, Vein Research Center, PC
Alpharetta, Georgia, 30022, United States
Skin Care Physicians of Georgia
Macon, Georgia, 31217, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Dermatology Institute of Dupage Medical Group
Wheaton, Illinois, 60189, United States
Qualmedica Research LLC
Evansville, Indiana, 47715, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250, United States
Dermatology Specialists Research Indiana
New Albany, Indiana, 47150, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Kansas City Dermatology, PA
Overland Park, Kansas, 66215, United States
Dermatology Specialist
Louisville, Kentucky, 40241, United States
Owensboro Dermatology Associates
Owensboro, Kentucky, 42303, United States
Lawrence J Green, M.D, LLC
Rockville, Maryland, 20850, United States
ActivMed Practices & Research, Inc
Beverly, Massachusetts, 01915, United States
Fivenson Dermatology
Ann Arbor, Michigan, 48103, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Clarkston Skin Research
Clarkston, Michigan, 48346, United States
Henry Ford Medical Center- New Center One
Detroit, Michigan, 48202, United States
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, 49085, United States
Central Dermatology PC
St Louis, Missouri, 63117, United States
Impact Clinical Trials
Las Vegas, Nevada, 89106, United States
ActivMed Practices & Research, Inc
Portsmouth, New Hampshire, 03801, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Forest Hills Dermatology Group
Forest Hills, New York, 11375, United States
Sadick Research Group
New York, New York, 10075, United States
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, 28277, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28411, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Wright State Univ School of Medicine
Fairborn, Ohio, 45324, United States
Ohio State Univ College Of Medicine
Gahanna, Ohio, 43230, United States
Dermatologists of Southwest Ohio, Inc.
Mason, Ohio, 45040, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, 19341, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Yardley Dermatology
Yardley, Pennsylvania, 19067, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
International Clinical Research
Murfreesboro, Tennessee, 37130, United States
Arlington Research Center, Inc
Arlington, Texas, 76011, United States
Austin Institute for Clinical Research, Inc.
Austin, Texas, 78705, United States
Bellaire Dermatology
Bellaire, Texas, 77401, United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230, United States
Modern Research Associates PLLC
Dallas, Texas, 75231, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Stephen L Miller, MD, PA
San Antonio, Texas, 78249, United States
University of Utah MidValley Dematology
Murray, Utah, 84107, United States
Virginia Clinical Research
Norfolk, Virginia, 23502, United States
Virginia Dermatology & Skin Cancer Center
Norfolk, Virginia, 23502, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
National Clinical Research - Richmond
Richmond, Virginia, 23294, United States
Dermatology Associates
Seattle, Washington, 98101, United States
West Virginia Research Institute
Morgantown, West Virginia, 26505, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Dermatology Research Institute Inc.
Calgary, Alberta, T1Y 0B4, Canada
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Karma Clinical Trials Inc
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
Eastern Canada Cutaneous Research Assoicates Ltd
Halifax, Nova Scotia, B3H1Z2, Canada
Dermatrials Research Inc.
Hamilton, Ontario, L8N 1Y2, Canada
Mediprobe Research Inc
London, Ontario, N5X 2P1, Canada
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc
Markham, Ontario, L3P1X2, Canada
DermEdge Research Inc
Mississauga, Ontario, L5H 1G9, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, N2J 1C4, Canada
Dr Isabelle Delorme Inc.
Drummondville, Quebec, J2B 5L4, Canada
Innovaderm Research Inc
Montreal, Quebec, H2K4L5, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2, Canada
Centro Reumatologico de Caguas
Caguas, PR, 00725, Puerto Rico
Office of Dr. Samuel Sanchez PSC
Caguas, PR, 00727, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716, Puerto Rico
GCM Medical Group PSC
San Juan, PR, 00909, Puerto Rico
Mindful Medical Research
San Juan, PR, 00918, Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, 00961-6911, Puerto Rico
Related Publications (4)
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.
PMID: 38521874DERIVEDGooderham 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.
PMID: 38332436DERIVEDElewski 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.
PMID: 35279805DERIVEDBlauvelt 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.
PMID: 32880909DERIVED
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 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
June 29, 2018
Study Start
November 9, 2018
Primary Completion
July 15, 2019
Study Completion
January 8, 2020
Last Updated
July 28, 2020
Results First Posted
July 28, 2020
Record last verified: 2020-02
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 European Union (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.
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.