Suspended
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
What is being tested
LY3454738
+ Placebo
Drug
Who is being recruted
Chronic Urticaria+9
+ Chronic Disease
+ Hypersensitivity
From 18 to 65 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: November 2019
Summary
Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 15, 2019
Actual date on which the first participant was enrolled.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.
Official TitleA 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
Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
52 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Chronic UrticariaChronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsUrticariaSkin and Connective Tissue DiseasesSkin Diseases, VascularDisease Attributes
Criteria
5 inclusion criteria required to participate
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
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5 exclusion criteria prevent from participating
Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling beneath the skin)
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.)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Experimental500 milligram (mg) LY3454738 administered intravenously (IV).
Group II
PlaceboPlacebo administered IV.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 25 locations
Suspended
Suspended
First OC Dermatology
Fountain Valley, United StatesSuspended
Antelope Valley Clinical Trials
Lancaster, United StatesSuspended
California Allergy and Asthma Medical Group + Research Center
Los Angeles, United StatesSuspended25 Study Centers