Recruiting
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
J1B-MC-FRCF - ClinicalTrials.gov - NCT04159701
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.
How long will I be in the trial?
The study will last about 39 weeks and may include up to 18 visits.
Recruiting
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
J1B-MC-FRCF - ClinicalTrials.gov - NCT04159701
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.
How long will I be in the trial?
The study will last about 39 weeks and may include up to 18 visits.
Key Requirements
Age :
18-65
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18-65
Sex
All
Participants must
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
Participants must NOT
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.)
Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU
Trial Summary
Conditions the trial is for
Hives
What the trial is testing?
LY3454738, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
60
Trial Dates
November 2019 - September 2021
Trial Phase
2
Enter your postal code to find the nearest site
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18-65
Sex
All
Participants must
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
Participants must NOT
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.)
Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU
Trial Summary
Conditions the trial is for
Hives
What the trial is testing?
LY3454738, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
60
Trial Dates
November 2019 - September 2021
Trial Phase
2
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Trial Locations
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Hives Resources
