search
Back to results

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis (IXORA-R)

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ixekizumab
Guselkumab
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring biologic, biologic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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).

Sites / Locations

  • Total Skin and Beauty Dermatology Center PC
  • University of Alabama at Birmingham
  • Alliance Dermatology and Mohs Center
  • Perseverance Research Center
  • Johnson Dermatology
  • Bakersfield Dermatology and Skin Cancer Medical Group
  • Wallace Medical Group, Inc.
  • California Dermatology and Clinical Research Institute
  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology
  • Center for Dermatology Clinical Research, Inc.
  • Advanced Research Center
  • Axis Clinical Trials
  • Dermatology Clinical Trials
  • Quest Dermatology Research
  • Northern California Research Corporation
  • Advanced Research Center
  • Medical Center for Clinical Research
  • University Clinical Trials, Inc.
  • Synergy Dermatology
  • Southern California Dermatology
  • Mosaic Dermatology
  • Clinical Science Institute
  • Unison Clinical Trials
  • Care Access Research-Walnut Creek
  • Dermatology Physicians of Connecticut
  • Florida Academic Dermatology Centers
  • Olympian Clinical Research
  • Suncoast Research Group, LLC
  • Miami Dermatology & Laser Research
  • Suncoast Clinical Research
  • Renstar Medical Research
  • Sensible Healthcare
  • Park Avenue Dermatology
  • International Clinical Research
  • MOORE Clinical Research
  • ForCare Clinical Research
  • Olympian Clinical Research
  • Atlanta Dermatology, Vein Research Center, PC
  • Skin Care Physicians of Georgia
  • Arlington Dermatology
  • Dermatology Institute of Dupage Medical Group
  • Qualmedica Research LLC
  • Dawes Fretzin Clinical Research
  • Dermatology Specialists Research Indiana
  • The Indiana Clinical Trials Center, PC
  • The South Bend Clinic
  • Integrated Clinical Trial Services, Inc.
  • Kansas City Dermatology, PA
  • Dermatology Specialist
  • Owensboro Dermatology Associates
  • Lawrence J Green, M.D, LLC
  • ActivMed Practices & Research, Inc
  • Fivenson Dermatology
  • Great Lakes Research Group, Inc.
  • Clarkston Skin Research
  • Henry Ford Medical Center- New Center One
  • St Joseph Dermatology and Vein Clinic
  • Central Dermatology PC
  • Impact Clinical Trials
  • ActivMed Practices & Research, Inc
  • Psoriasis Treatment Center of Central New Jersey
  • Forest Hills Dermatology Group
  • Sadick Research Group
  • Piedmont Plastic Surgery and Dermatology
  • Dermatology Consulting Services
  • PMG Research of Rocky Mount, LLC
  • PMG Research of Wilmington, LLC
  • Bexley Dermatology Research
  • University Hospitals Cleveland Medical Center
  • Wright State Univ School of Medicine
  • Ohio State Univ College Of Medicine
  • Dermatologists of Southwest Ohio, Inc.
  • Oregon Medical Research Center
  • Dermatology and Skin Surgery Center
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center
  • Yardley Dermatology
  • Clinical Partners LLC
  • Clinical Research Center of the Carolinas
  • International Clinical Research
  • Arlington Research Center, Inc
  • Austin Institute for Clinical Research, Inc.
  • Bellaire Dermatology
  • Dermatology Treatment and Research Center
  • Modern Research Associates PLLC
  • Center for Clinical Studies
  • Suzanne Bruce and Associates, PA
  • Progressive Clinical Research
  • Dermatology Clinical Research Center of San Antonio
  • Stephen L Miller, MD, PA
  • University of Utah MidValley Dematology
  • Virginia Clinical Research
  • Virginia Dermatology & Skin Cancer Center
  • Eastern Virginia Medical School
  • National Clinical Research - Richmond
  • Dermatology Associates
  • West Virginia Research Institute
  • Medical College of Wisconsin
  • Dermatology Research Institute Inc.
  • Kirk Barber Research
  • Stratica Medical
  • Dr. Chih-ho Hong Medical Inc.
  • Enverus Medical Research
  • Wiseman Dermatology Research Inc.
  • Karma Clinical Trials Inc
  • Eastern Canada Cutaneous Research Assoicates Ltd
  • Dermatrials Research Inc.
  • Mediprobe Research Inc
  • The Guenther Dermatology Research Centre
  • Lynderm Research Inc
  • DermEdge Research Inc
  • North Bay Dermatology Centre
  • SKiN Centre for Dermatology
  • The Centre for Dermatology
  • K. Papp Clinical Research Inc
  • Dr Isabelle Delorme Inc.
  • Innovaderm Research Inc
  • Q&T Research Sherbrooke Inc
  • Santa Cruz Behavioral PSC
  • Centro Reumatologico de Caguas
  • Office of Dr. Samuel Sanchez PSC
  • Ponce School of Medicine CAIMED Center
  • GCM Medical Group PSC
  • Mindful Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ixekizumab

Guselkumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 20, 2018
Last Updated
July 10, 2020
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03573323
Brief Title
A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
Acronym
IXORA-R
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
biologic, biologic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1027 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ixekizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Guselkumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab
Other Intervention Name(s)
LY2439821
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving PASI 75
Description
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.
Time Frame
Week 2
Title
Percentage of Participants Achieving PASI 90
Description
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.
Time Frame
Week 4
Title
Percentage of Participants Achieving PASI 100
Description
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.
Time Frame
Week 4
Title
Percentage of Participants Achieving PASI 90
Description
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.
Time Frame
Week 8
Title
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Achieving PASI 50
Description
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.
Time Frame
Week 1
Title
Percentage of Participants Achieving PASI 100
Description
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.
Time Frame
Week 8
Title
Percentage of Participants Achieving PASI 100
Description
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.
Time Frame
Week 24

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org
Citations:
PubMed Identifier
35279805
Citation
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.
Results Reference
derived
PubMed Identifier
32880909
Citation
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.
Results Reference
derived

Learn more about this trial

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

We'll reach out to this number within 24 hrs