A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
NCT ID: NCT04159701
Last Updated: 2022-03-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
52 participants
INTERVENTIONAL
2019-11-15
2021-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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LY3454738
500 milligram (mg) LY3454738 administered intravenously (IV).
LY3454738
Administered IV
Placebo
Placebo administered IV.
Placebo
Administered IV
Interventions
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LY3454738
Administered IV
Placebo
Administered IV
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Must not have a current or recent active infection requiring antibiotics
* Must not have a history of anaphylaxis (severe, life threatening allergic reaction)
* Must not have asthma requiring medications other than short acting beta agonists (albuterol, etc.)
* Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Kern Research, Inc
Bakersfield, California, United States
First OC Dermatology
Fountain Valley, California, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
California Allergy and Asthma Medical Group + Research Center
Los Angeles, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
Florida Center for Allergy & Asthma Research Landman
Aventura, Florida, United States
Florida Center for Allergy & Asthma Research Rodicio
Miami, Florida, United States
Miami Dermatology and Laser Research
Miami, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
University of South Florida Asthma, Allergy and Immunology
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States
Signature Allergy & Immunology
St Louis, Missouri, United States
Optimed Research, LTD
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Northwest Research Center
Portland, Oregon, United States
Medizinische Hochschule Hanover
Hanover, Lower Saxony, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
Charité Campus Virchow-Klinikum
Berlin, , Germany
Rothhaar Studien GmbH
Berlin, , Germany
Diamond Clinic
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
Other Identifiers
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J1B-MC-FRCF
Identifier Type: OTHER
Identifier Source: secondary_id
2019-002495-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17480
Identifier Type: -
Identifier Source: org_study_id
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