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

Plaque Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573323
• Other study ID #: 17119
• Secondary ID: I1F-MC-RHCR
• Status: Completed
• Phase: Phase 4
• 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
• 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).

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

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