A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to Evaluate the Efficacy and Safety of LY3454738 in Adults With Chronic Spontaneous Urticaria Inadequately Controlled With H1-Antihistamines
Who is this study for? Adults with chronic spontaneous urticaria
What treatments are being studied? LY3454738
Status: Terminated
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Must agree to use appropriate birth control throughout the study
• Must have a diagnosis of CSU for at least 6 months
• Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines
• Must agree to take an anti-histamine every day during the trial
• Must be willing to enter information about symptoms in an electronic diary twice a day
Locations
United States
California
Kern Research, Inc
Bakersfield
First OC Dermatology
Fountain Valley
Antelope Valley Clinical Trials
Lancaster
California Allergy and Asthma Medical Group + Research Center
Los Angeles
Allergy & Asthma Consultants
Redwood City
Florida
Florida Center for Allergy & Asthma Research Landman
Aventura
Florida Center for Allergy & Asthma Research Rodicio
Miami
Miami Dermatology and Laser Research
Miami
Sarasota Clinical Research
Sarasota
ForCare Clinical Research
Tampa
University of South Florida Asthma, Allergy and Immunology
Tampa
Idaho
Treasure Valley Medical Research
Boise
Kentucky
Allergy & Asthma Specialists, P.S.C.
Owensboro
Maryland
Johns Hopkins Asthma and Allergy Center
Baltimore
Missouri
Signature Allergy & Immunology
Saint Louis
Ohio
Optimed Research, LTD
Columbus
Oklahoma
Vital Prospects Clinical Research Institute, P.C.
Tulsa
Oregon
Northwest Research Center
Portland
Other Locations
Germany
Charité Campus Virchow-Klinikum
Berlin
Rothhaar Studien GmbH
Berlin
Medizinische Hochschule Hanover
Hannover
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz
Universitätsklinikum Münster
Münster
Poland
Diamond Clinic
Krakow
Centrum Medyczne Evimed
Warszawa
Time Frame
Start Date: 2019-11-15
Completion Date: 2021-02-24
Participants
Target number of participants: 52
Treatments
Experimental: LY3454738
500 milligram (mg) LY3454738 administered intravenously (IV).
Placebo_comparator: Placebo
Placebo administered IV.
Authors
Ileana Rodicio, Jill Waibel, Eric Boren, Brian Lipson, Hamsa Subramanian, Scott Dinehart, Duane Harris, Jaime Landman, Thomas Casale, Ricardo Tan, Vivian Thuy-Vy Laquer, Anthony Montanaro, Seth Forman, Iftikhar Hussain, Stephen Fritz, Donald McNeil, Jonathan S. Glass, Hugh Windom, Susan Taylor, Neetu Talreja, Bettina Wedi, Randolf Brehler, Petra Staubach-Renz, Barbara Rewerska
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company