Terminated

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.
Email
Terminated

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.
Email

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 - February 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 - February 2021

Trial Phase

2

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Trial Locations

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Hives Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?