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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03573323
Other study ID # 17119
Secondary ID I1F-MC-RHCR
Status Completed
Phase Phase 4
First received
Last updated
Start date November 9, 2018
Est. completion date January 8, 2020

Study information

Verified date February 2020
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1027
Est. completion date January 8, 2020
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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- Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Ixekizumab
Administered SC
Guselkumab
Administered SC
Placebo
Administered SC

Locations

Country Name City State
Canada Dermatology Research Institute Inc. Calgary Alberta
Canada Kirk Barber Research Calgary Alberta
Canada Dr Isabelle Delorme Inc. Drummondville Quebec
Canada Stratica Medical Edmonton Alberta
Canada Eastern Canada Cutaneous Research Assoicates Ltd Halifax Nova Scotia
Canada Dermatrials Research Inc. Hamilton Ontario
Canada Mediprobe Research Inc London Ontario
Canada The Guenther Dermatology Research Centre London Ontario
Canada Lynderm Research Inc Markham Ontario
Canada DermEdge Research Inc Mississauga Ontario
Canada Innovaderm Research Inc Montreal Quebec
Canada North Bay Dermatology Centre North Bay Ontario
Canada SKiN Centre for Dermatology Peterborough Ontario
Canada The Centre for Dermatology Richmond Hill Ontario
Canada Q&T Research Sherbrooke Inc Sherbrooke Quebec
Canada Karma Clinical Trials Inc St. John's Newfoundland and Labrador
Canada Dr. Chih-ho Hong Medical Inc. Surrey British Columbia
Canada Enverus Medical Research Surrey British Columbia
Canada K. Papp Clinical Research Inc Waterloo Ontario
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
Puerto Rico Santa Cruz Behavioral PSC Bayamón
Puerto Rico Centro Reumatologico de Caguas Caguas
Puerto Rico Office of Dr. Samuel Sanchez PSC Caguas
Puerto Rico Ponce School of Medicine CAIMED Center Ponce
Puerto Rico GCM Medical Group PSC San Juan
Puerto Rico Mindful Medical Research San Juan
United States Atlanta Dermatology, Vein Research Center, PC Alpharetta Georgia
United States Fivenson Dermatology Ann Arbor Michigan
United States Arlington Research Center, Inc Arlington Texas
United States Austin Institute for Clinical Research, Inc. Austin Texas
United States Bakersfield Dermatology and Skin Cancer Medical Group Bakersfield California
United States Great Lakes Research Group, Inc. Bay City Michigan
United States Bellaire Dermatology Bellaire Texas
United States ActivMed Practices & Research, Inc Beverly Massachusetts
United States Wallace Medical Group, Inc. Beverly Hills California
United States Bexley Dermatology Research Bexley Ohio
United States Total Skin and Beauty Dermatology Center PC Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
United States Clinical Research Center of the Carolinas Charleston South Carolina
United States Piedmont Plastic Surgery and Dermatology Charlotte North Carolina
United States Clarkston Skin Research Clarkston Michigan
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Florida Academic Dermatology Centers Coral Gables Florida
United States Dermatology Treatment and Research Center Dallas Texas
United States Modern Research Associates PLLC Dallas Texas
United States Henry Ford Medical Center- New Center One Detroit Michigan
United States Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey
United States California Dermatology and Clinical Research Institute Encinitas California
United States Qualmedica Research LLC Evansville Indiana
United States Dermatology and Skin Surgery Center Exton Pennsylvania
United States Wright State Univ School of Medicine Fairborn Ohio
United States Forest Hills Dermatology Group Forest Hills New York
United States Johnson Dermatology Fort Smith Arkansas
United States Tien Q. Nguyen, MD inc. DBA First OC Dermatology Fountain Valley California
United States Center for Dermatology Clinical Research, Inc. Fremont California
United States Ohio State Univ College Of Medicine Gahanna Ohio
United States Dermatology Consulting Services High Point North Carolina
United States Center for Clinical Studies Houston Texas
United States Suzanne Bruce and Associates, PA Houston Texas
United States Dawes Fretzin Clinical Research Indianapolis Indiana
United States Clinical Partners LLC Johnston Rhode Island
United States Olympian Clinical Research Largo Florida
United States Impact Clinical Trials Las Vegas Nevada
United States Advanced Research Center Los Alamitos California
United States Axis Clinical Trials Los Angeles California
United States Dermatology Specialist Louisville Kentucky
United States Skin Care Physicians of Georgia Macon Georgia
United States Dermatologists of Southwest Ohio, Inc. Mason Ohio
United States Miami Dermatology & Laser Research Miami Florida
United States Suncoast Research Group, LLC Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States West Virginia Research Institute Morgantown West Virginia
United States International Clinical Research Murfreesboro Tennessee
United States University of Utah MidValley Dematology Murray Utah
United States Dermatology Specialists Research Indiana New Albany Indiana
United States Suncoast Clinical Research New Port Richey Florida
United States Sadick Research Group New York New York
United States Dermatology Clinical Trials Newport Beach California
United States Eastern Virginia Medical School Norfolk Virginia
United States Virginia Clinical Research Norfolk Virginia
United States Virginia Dermatology & Skin Cancer Center Norfolk Virginia
United States Quest Dermatology Research Northridge California
United States Renstar Medical Research Ocala Florida
United States Sensible Healthcare Ocoee Florida
United States Park Avenue Dermatology Orange Park Florida
United States Kansas City Dermatology, PA Overland Park Kansas
United States Owensboro Dermatology Associates Owensboro Kentucky
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Alliance Dermatology and Mohs Center Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States The Indiana Clinical Trials Center, PC Plainfield Indiana
United States Oregon Medical Research Center Portland Oregon
United States ActivMed Practices & Research, Inc Portsmouth New Hampshire
United States National Clinical Research - Richmond Richmond Virginia
United States Lawrence J Green, M.D, LLC Rockville Maryland
United States PMG Research of Rocky Mount, LLC Rocky Mount North Carolina
United States Arlington Dermatology Rolling Meadows Illinois
United States Northern California Research Corporation Sacramento California
United States St Joseph Dermatology and Vein Clinic Saint Joseph Michigan
United States Central Dermatology PC Saint Louis Missouri
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Progressive Clinical Research San Antonio Texas
United States Stephen L Miller, MD, PA San Antonio Texas
United States Advanced Research Center San Diego California
United States Medical Center for Clinical Research San Diego California
United States University Clinical Trials, Inc. San Diego California
United States Synergy Dermatology San Francisco California
United States International Clinical Research Sanford Florida
United States Southern California Dermatology Santa Ana California
United States Clinical Science Institute Santa Monica California
United States Mosaic Dermatology Santa Monica California
United States Perseverance Research Center Scottsdale Arizona
United States Dermatology Associates Seattle Washington
United States Dermatology Physicians of Connecticut Shelton Connecticut
United States Unison Clinical Trials Sherman Oaks California
United States The South Bend Clinic South Bend Indiana
United States ForCare Clinical Research Tampa Florida
United States MOORE Clinical Research Tampa Florida
United States Olympian Clinical Research Tampa Florida
United States Care Access Research-Walnut Creek Walnut Creek California
United States Integrated Clinical Trial Services, Inc. West Des Moines Iowa
United States Dermatology Institute of Dupage Medical Group Wheaton Illinois
United States PMG Research of Wilmington, LLC Wilmington North Carolina
United States Yardley Dermatology Yardley Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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