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

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Ixekizumab; Drug: Placebo; Drug: Guselkumab

• Study Type: Interventional
• Enrollment (Actual): 1027
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research
    • Calgary, Alberta, Canada, T1Y 0B4
      • Dermatology Research Institute Inc.
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-Ho Hong Medical Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials Inc
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H1Z2
      • Eastern Canada Cutaneous Research Assoicates Ltd
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research Inc.
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research Inc
    • Markham, Ontario, Canada, L3P1X2
      • Lynderm Research Inc
    • Mississauga, Ontario, Canada, L5H 1G9
      • DermEdge Research Inc
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research Inc
  • Quebec
    • Drummondville, Quebec, Canada, J2B 5L4
      • Dr Isabelle Delorme Inc.
    • Montreal, Quebec, Canada, H2K4L5
      • Innovaderm Research Inc
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • Q&T Research Sherbrooke Inc
• Puerto Rico
  • Bayamón, Puerto Rico, 00961-6911
    • Santa Cruz Behavioral PSC
  • Caguas, Puerto Rico, 00727
    • Office of Dr. Samuel Sanchez PSC
  • Caguas, Puerto Rico, 00725
    • Centro Reumatologico de Caguas
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine CAIMED Center
  • San Juan, Puerto Rico, 00909
    • GCM Medical Group PSC
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center PC
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Dermatology and Skin Cancer Medical Group
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group, Inc.
    • Encinitas, California, United States, 92024
      • California Dermatology and Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • Tien Q. Nguyen, MD inc. DBA First OC Dermatology
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
    • Los Alamitos, California, United States, 90720
      • Advanced Research Center
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Newport Beach, California, United States, 92660
      • Dermatology Clinical Trials
    • Northridge, California, United States, 91324
      • Quest Dermatology Research
    • Sacramento, California, United States, 95821
      • Northern California Research Corporation
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92123
      • University Clinical Trials, Inc.
    • San Diego, California, United States, 92103
      • Advanced Research Center
    • San Francisco, California, United States, 94132
      • Synergy Dermatology
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Santa Monica, California, United States, 90403
      • Mosaic Dermatology
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
    • Walnut Creek, California, United States, 94598
      • Care Access Research-Walnut Creek
  • Connecticut
    • Shelton, Connecticut, United States, 06484
      • Dermatology Physicians of Connecticut
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Dermatology Centers
    • Largo, Florida, United States, 33770
      • Olympian Clinical Research
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLC
    • Miami, Florida, United States, 33173
      • Miami Dermatology & Laser Research
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology
    • Sanford, Florida, United States, 32771
      • International Clinical Research
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
    • Tampa, Florida, United States, 33609
      • MOORE Clinical Research
    • Tampa, Florida, United States, 33614
      • Olympian Clinical Research
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein Research Center, PC
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Wheaton, Illinois, United States, 60189
      • Dermatology Institute of DuPage Medical Group
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research LLC
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research
    • New Albany, Indiana, United States, 47150
      • Dermatology Specialists Research Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center, PC
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services, Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Kansas City Dermatology, PA
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Dermatology Specialist
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Dermatology Associates
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J Green, M.D, LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ActivMed Practices & Research, Inc
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Fivenson Dermatology
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Clarkston, Michigan, United States, 48346
      • Clarkston Skin Research
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center- New Center One
    • Saint Joseph, Michigan, United States, 49085
      • St Joseph Dermatology and Vein Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology PC
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Impact Clinical Trials
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research, Inc
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
  • New York
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10075
      • Sadick Research Group
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Piedmont Plastic Surgery and Dermatology
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount, LLC
    • Wilmington, North Carolina, United States, 28411
      • PMG Research of Wilmington, LLC
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley Dermatology Research
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Fairborn, Ohio, United States, 45324
      • Wright State Univ School of Medicine
    • Gahanna, Ohio, United States, 43230
      • Ohio State Univ College Of Medicine
    • Mason, Ohio, United States, 45040
      • Dermatologists of Southwest Ohio, Inc.
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Dermatology and Skin Surgery Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Yardley, Pennsylvania, United States, 19067
      • Yardley Dermatology
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc
    • Austin, Texas, United States, 78705
      • Austin Institute for Clinical Research, Inc.
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology
    • Dallas, Texas, United States, 75231
      • Modern Research Associates PLLC
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • San Antonio, Texas, United States, 78249
      • Stephen L Miller, MD, PA
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah MidValley Dematology
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research
    • Norfolk, Virginia, United States, 23502
      • Virginia Dermatology & Skin Cancer Center
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia Research Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821
Experimental: 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.	Drug: Placebo; Administered SC; Drug: Guselkumab; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving PASI 75	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.	Week 2
Percentage of Participants Achieving PASI 90	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.	Week 4
Percentage of Participants Achieving 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 4
Percentage of Participants Achieving PASI 90	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.	Week 8
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)	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.	Week 12
Percentage of Participants Achieving PASI 50	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.	Week 1
Percentage of Participants Achieving 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 8
Percentage of Participants Achieving 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 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: biologic; biologic therapy
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ixekizumab
• Other Study ID Numbers: 17119; I1F-MC-RHCR (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No