Clinical trial NCT03573323: A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: biologic
biologic therapy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 1027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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

Primary outcomes:
measure: Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving PASI 75
timeFrame: Week 2
measure: Percentage of Participants Achieving PASI 90
timeFrame: Week 4
measure: Percentage of Participants Achieving PASI 100
timeFrame: Week 4
measure: Percentage of Participants Achieving PASI 90
timeFrame: Week 8
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)
timeFrame: Week 12
measure: Percentage of Participants Achieving PASI 50
timeFrame: Week 1
measure: Percentage of Participants Achieving PASI 100
timeFrame: Week 8
measure: Percentage of Participants Achieving PASI 100
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center PC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Beverly Hills
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Encinitas
country: United States
facility: California Dermatology and Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Los Alamitos
country: United States
facility: Advanced Research Center
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Newport Beach
country: United States
facility: Dermatology Clinical Trials
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Sacramento
country: United States
facility: Northern California Research Corporation
state: California
city: San Diego
country: United States
facility: Advanced Research Center
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: San Francisco
country: United States
facility: Synergy Dermatology
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Santa Monica
country: United States
facility: Mosaic Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Walnut Creek
country: United States
facility: Care Access Research-Walnut Creek
state: California
city: Shelton
country: United States
facility: Dermatology Physicians of Connecticut
state: Connecticut
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Miami Dermatology & Laser Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Sanford
country: United States
facility: International Clinical Research
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein Research Center, PC
state: Georgia
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Wheaton
country: United States
facility: Dermatology Institute of Dupage Medical Group
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research LLC
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: New Albany
country: United States
facility: Dermatology Specialists Research Indiana
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialist
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Dermatology Associates
state: Kentucky
city: Rockville
country: United States
facility: Lawrence J Green, M.D, LLC
state: Maryland
city: Beverly
country: United States
facility: ActivMed Practices & Research, Inc
state: Massachusetts
city: Ann Arbor
country: United States
facility: Fivenson Dermatology
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center- New Center One
state: Michigan
city: Saint Joseph
country: United States
facility: St Joseph Dermatology and Vein Clinic
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Charlotte
country: United States
facility: Piedmont Plastic Surgery and Dermatology
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Fairborn
country: United States
facility: Wright State Univ School of Medicine
state: Ohio
city: Gahanna
country: United States
facility: Ohio State Univ College Of Medicine
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Exton
country: United States
facility: Dermatology and Skin Surgery Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Austin
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Stephen L Miller, MD, PA
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dematology
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Norfolk
country: United States
facility: Virginia Dermatology & Skin Cancer Center
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc.
state: Alberta
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: St. John's
country: Canada
facility: Karma Clinical Trials Inc
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Assoicates Ltd
state: Nova Scotia
city: Hamilton
country: Canada
facility: Dermatrials Research Inc.
state: Ontario
city: London
country: Canada
facility: Mediprobe Research Inc
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc
state: Ontario
city: Drummondville
country: Canada
facility: Dr Isabelle Delorme Inc.
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc
state: Quebec
city: Bayamón
country: Puerto Rico
facility: Santa Cruz Behavioral PSC
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico de Caguas
city: Caguas
country: Puerto Rico
facility: Office of Dr. Samuel Sanchez PSC
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine CAIMED Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.
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.