A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
Study Purpose
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 Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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 sPGA score of ≥3 and a 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- - Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating other IL-17 or IL-23p19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).
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03573323 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
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) |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Canada, Puerto Rico, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Plaque Psoriasis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, 35205
Status
Recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Status
Recruiting
Address
Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032
Status
Recruiting
Address
Perseverance Research Center
Scottsdale, Arizona, 85254
Status
Recruiting
Address
Johnson Dermatology
Fort Smith, Arkansas, 72916
Status
Recruiting
Address
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309
Status
Recruiting
Address
Wallace Medical Group, Inc.
Beverly Hills, California, 90211
Status
Recruiting
Address
California Dermatology and Clinical Research Institute
Encinitas, California, 92024
Status
Recruiting
Address
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, 92708
Status
Recruiting
Address
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Status
Recruiting
Address
Advanced Research Center
Los Alamitos, California, 90720
Status
Recruiting
Address
Axis Clinical Trials
Los Angeles, California, 90036
Status
Recruiting
Address
Dermatology Clinical Trials
Newport Beach, California, 92660
Status
Recruiting
Address
Quest Dermatology Research
Northridge, California, 91324
Status
Recruiting
Address
Northern California Research Corporation
Sacramento, California, 95821
Status
Recruiting
Address
Advanced Research Center
San Diego, California, 92103
Status
Recruiting
Address
Medical Center for Clinical Research
San Diego, California, 92108
Status
Recruiting
Address
University Clinical Trials, Inc.
San Diego, California, 92123
Status
Recruiting
Address
Synergy Dermatology
San Francisco, California, 94132
Status
Recruiting
Address
Southern California Dermatology
Santa Ana, California, 92701
Status
Recruiting
Address
Mosaic Dermatology
Santa Monica, California, 90403
Status
Recruiting
Address
Clinical Science Institute
Santa Monica, California, 90404
Status
Recruiting
Address
Unison Clinical Trials
Sherman Oaks, California, 91403
Status
Recruiting
Address
Care Access Research-Walnut Creek
Walnut Creek, California, 94598
Status
Recruiting
Address
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
Status
Recruiting
Address
Dermatology Physicians of Connecticut
Shelton, Connecticut, 06484
Status
Recruiting
Address
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134
Status
Recruiting
Address
Olympian Clinical Research
Largo, Florida, 33770
Status
Recruiting
Address
Suncoast Research Group, LLC
Miami, Florida, 33135
Status
Recruiting
Address
Miami Dermatology & Laser Research
Miami, Florida, 33173
Status
Recruiting
Address
Suncoast Clinical Research
New Port Richey, Florida, 34652
Status
Recruiting
Address
Renstar Medical Research
Ocala, Florida, 34470
Status
Recruiting
Address
Sensible Healthcare
Ocoee, Florida, 34761
Status
Recruiting
Address
Park Avenue Dermatology
Orange Park, Florida, 32073
Status
Recruiting
Address
International Clinical Research
Sanford, Florida, 32771
Status
Recruiting
Address
MOORE Clinical Research
Tampa, Florida, 33609
Status
Recruiting
Address
ForCare Clinical Research
Tampa, Florida, 33613
Status
Recruiting
Address
Olympian Clinical Research
Tampa, Florida, 33614
Status
Recruiting
Address
Atlanta Dermatology, Vein Research Center, PC
Alpharetta, Georgia, 30022
Status
Recruiting
Address
Skin Care Physicians of Georgia
Macon, Georgia, 31217
Status
Recruiting
Address
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Status
Recruiting
Address
Dermatology Institute of Dupage Medical Group
Wheaton, Illinois, 60189
Status
Recruiting
Address
Qualmedica Research LLC
Evansville, Indiana, 47715
Status
Recruiting
Address
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250
Status
Recruiting
Address
Dermatology Specialists Research Indiana
New Albany, Indiana, 47150
Status
Recruiting
Address
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Status
Recruiting
Address
The South Bend Clinic
South Bend, Indiana, 46617
Status
Recruiting
Address
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265
Status
Recruiting
Address
Kansas City Dermatology, PA
Overland Park, Kansas, 66215
Status
Recruiting
Address
Dermatology Specialist
Louisville, Kentucky, 40241
Status
Recruiting
Address
Owensboro Dermatology Associates
Owensboro, Kentucky, 42303
Status
Recruiting
Address
Lawrence J Green, M.D, LLC
Rockville, Maryland, 20850
Status
Recruiting
Address
ActivMed Practices & Research, Inc
Beverly, Massachusetts, 01915
Status
Recruiting
Address
Fivenson Dermatology
Ann Arbor, Michigan, 48103
Status
Recruiting
Address
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Status
Recruiting
Address
Clarkston Skin Research
Clarkston, Michigan, 48346
Status
Recruiting
Address
Henry Ford Medical Center- New Center One
Detroit, Michigan, 48202
Status
Recruiting
Address
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, 49085
Status
Recruiting
Address
Central Dermatology PC
Saint Louis, Missouri, 63117
Status
Recruiting
Address
Impact Clinical Trials
Las Vegas, Nevada, 89106
Status
Recruiting
Address
ActivMed Practices & Research, Inc
Portsmouth, New Hampshire, 03801
Status
Recruiting
Address
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Status
Recruiting
Address
Forest Hills Dermatology Group
Forest Hills, New York, 11375
Status
Recruiting
Address
Sadick Research Group
New York, New York, 10075
Status
Recruiting
Address
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, 28277
Status
Recruiting
Address
Dermatology Consulting Services
High Point, North Carolina, 27262
Status
Recruiting
Address
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804
Status
Recruiting
Address
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28411
Status
Recruiting
Address
Bexley Dermatology Research
Bexley, Ohio, 43209
Status
Recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Status
Recruiting
Address
Wright State Univ School of Medicine
Fairborn, Ohio, 45324
Status
Recruiting
Address
Ohio State Univ College Of Medicine
Gahanna, Ohio, 43230
Status
Recruiting
Address
Dermatologists of Southwest Ohio, Inc.
Mason, Ohio, 45040
Status
Recruiting
Address
Oregon Medical Research Center
Portland, Oregon, 97223
Status
Recruiting
Address
Dermatology and Skin Surgery Center
Exton, Pennsylvania, 19341
Status
Recruiting
Address
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Yardley Dermatology
Yardley, Pennsylvania, 19067
Status
Recruiting
Address
Clinical Partners LLC
Johnston, Rhode Island, 02919
Status
Recruiting
Address
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Status
Recruiting
Address
International Clinical Research
Murfreesboro, Tennessee, 37130
Status
Recruiting
Address
Arlington Research Center, Inc
Arlington, Texas, 76011
Status
Recruiting
Address
Austin Institute for Clinical Research, Inc.
Austin, Texas, 78705
Status
Recruiting
Address
Bellaire Dermatology
Bellaire, Texas, 77401
Status
Recruiting
Address
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Status
Recruiting
Address
Modern Research Associates PLLC
Dallas, Texas, 75231
Status
Recruiting
Address
Center for Clinical Studies
Houston, Texas, 77004
Status
Recruiting
Address
Center for Clinical Studies
Houston, Texas, 77004
Status
Recruiting
Address
Progressive Clinical Research
San Antonio, Texas, 78213
Status
Recruiting
Address
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
Stephen L Miller, MD, PA
San Antonio, Texas, 78249
Status
Recruiting
Address
University of Utah MidValley Dematology
Murray, Utah, 84107
Status
Recruiting
Address
Virginia Clinical Research
Norfolk, Virginia, 23502
Status
Recruiting
Address
Virginia Dermatology & Skin Cancer Center
Norfolk, Virginia, 23502
Status
Recruiting
Address
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Status
Recruiting
Address
National Clinical Research - Richmond
Richmond, Virginia, 23294
Status
Recruiting
Address
Dermatology Associates
Seattle, Washington, 98101
Status
Recruiting
Address
West Virginia Research Institute
Morgantown, West Virginia, 26505
Status
Recruiting
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
Status
Recruiting
Address
Dermatology Research Institute Inc.
Calgary, Alberta, T1Y 0B4
Status
Recruiting
Address
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Status
Recruiting
Address
Stratica Medical
Edmonton, Alberta, T5K 1X3
Status
Recruiting
Address
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Status
Recruiting
Address
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Status
Recruiting
Address
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Status
Recruiting
Address
Karma Clinical Trials Inc
St. John's, Newfoundland and Labrador, A1A 4Y3
Status
Recruiting
Address
Eastern Canada Cutaneous Research Assoicates Ltd
Halifax, Nova Scotia, B3H1Z2
Status
Recruiting
Address
Dermatrials Research Inc.
Hamilton, Ontario, L8N 1Y2
Status
Recruiting
Address
Mediprobe Research Inc
London, Ontario, N5X 2P1
Status
Recruiting
Address
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Status
Recruiting
Address
Lynderm Research Inc
Markham, Ontario, L3P1X2
Status
Recruiting
Address
DermEdge Research Inc
Mississauga, Ontario, L5H 1G9
Status
Recruiting
Address
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Status
Recruiting
Address
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Status
Recruiting
Address
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Status
Recruiting
Address
K. Papp Clinical Research Inc
Waterloo, Ontario, N2J 1C4
Status
Recruiting
Address
Dr Isabelle Delorme Inc.
Drummondville, Quebec, J2B 5L4
Status
Recruiting
Address
Innovaderm Research Inc
Montreal, Quebec, H2K4L5
Status
Recruiting
Address
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2
Status
Recruiting
Address
Santa Cruz Behavioral PSC
Bayamón, , 00961-6911
Status
Recruiting
Address
Centro Reumatologico de Caguas
Caguas, , 00725
Status
Recruiting
Address
Office of Dr. Samuel Sanchez PSC
Caguas, , 00727
Status
Recruiting
Address
Ponce School of Medicine CAIMED Center
Ponce, , 00716
Status
Recruiting
Address
GCM Medical Group PSC
San Juan, , 00909
Status
Recruiting
Address
Mindful Medical Research
San Juan, , 00918
