Clinical trial NCT02513550: A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-07-31
Enrollment: 1257
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 main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

Detailed description: The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.

Eligibility criteria: Inclusion Criteria:

* Present with chronic plaque psoriasis for at least 6 months prior to enrollment
* At least 10% BSA of psoriasis at screening and at enrollment
* sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
* Candidates for phototherapy and/or systemic therapy
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
* Concurrent or recent use of any biologic agent
* Have participated in any study with ixekizumab
* Received a live vaccination within 12 weeks prior to enrollment
* Serious disorder or illness other than psoriasis
* Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
* Major surgery within 8 weeks of baseline, or will require surgery during the study
* Breastfeeding or nursing (lactating) women

Primary outcomes:
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
timeFrame: Week 52
measure: Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving sPGA (0)
timeFrame: Week 52
measure: Percentage of Participants Achieving PASI 90
timeFrame: Week 52
measure: Percentage of Participants Achieving PASI 100
timeFrame: Week 52
measure: Change From Baseline in PASI
timeFrame: Baseline, Week 52
measure: Percent Improvement in PASI
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in Palmoplantar PASI (PPASI)
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
timeFrame: Week 52
measure: Change From Baseline in DLQI Total Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Itch NRS Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Skin Pain Visual Analog Scale (VAS)
timeFrame: Baseline, Week 52
measure: Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
timeFrame: Baseline, Week 52
measure: Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
timeFrame: Predose, Week 4, 12, 24, 36 and 52 Post dose
measure: Number of Participants With Anti-Ixekizumab Antibodies
timeFrame: Baseline through Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center PC
state: Alabama
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Beverly Hills
country: United States
facility: David Stoll, M.D.
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
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: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc
state: Colorado
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Advanced Medical Research
state: Georgia
city: Darien
country: United States
facility: University Dermatology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Inc
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialist
state: Kentucky
city: Lake Charles
country: United States
facility: Dr. Shondra Smith MD
state: Louisiana
city: Rockville
country: United States
facility: DermAssociates, P.C.
state: Maryland
city: Beverly
country: United States
facility: ActivMed Practices & Research, Inc
state: Massachusetts
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Newington
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: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine Dermatology Clinical Trials
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Dermatology and Skin Cancer Center
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Tulsa
country: United States
facility: Healthcare Research Consultant
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
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: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pennsylvania Regional Center for Arthritis & Osteoarthritis
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: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center PC
state: Tennessee
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Pflugerville
country: United States
facility: Pflugerville Dermatology Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Buenos Aires
country: Argentina
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Mendoza
country: Argentina
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city: Benowa
country: Australia
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city: Carlton
country: Australia
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city: Darlinghurst
country: Australia
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city: Fremantle
country: Australia
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city: Phillip
country: Australia
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city: Woolloongabba
country: Australia
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city: Barrie
country: Canada
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city: Calgary
country: Canada
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city: Halifax
country: Canada
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city: Hamilton
country: Canada
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city: London
country: Canada
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city: Markham
country: Canada
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city: Montreal
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Oakville
country: Canada
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city: Peterborough
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Quebec
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Richmond Hill
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sherbrooke
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Surrey
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Waterloo
country: Canada
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city: Windsor
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Brno
country: Czechia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Novy Jicin
country: Czechia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Plzen-Bory
country: Czechia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Praha
country: Czechia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Berlin
country: Germany
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city: Darmstadt
country: Germany
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city: Kiel
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Mahlow
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Munster
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Budapest
country: Hungary
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Debrecen
country: Hungary
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Oroshaza
country: Hungary
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city: Szolnok
country: Hungary
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city: Osaka
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Takaoka
country: Japan
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city: Tsu
country: Japan
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city: Bucheon
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pusan
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seongnam
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Mexicali
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Mexico City
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Monterrey
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Morelia
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bialystok
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gdansk
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kielce
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Krakow
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lodz
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Swidnik
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Szczecin
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Wroclaw
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Caguas
country: Puerto Rico
facility: Office of Dr. Samuel Sanchez PSC
city: Carolina
country: Puerto Rico
facility: Office of Dr. Alma M. Cruz
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
city: Bucuresti
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Cluj Napoca
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Constanta
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Craiova
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Tainan
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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: