A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

Lilly

Status and phase: Terminated; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: LY3454738; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04159701

2019-002495-13 (EudraCT Number)

17480

J1B-MC-FRCF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

LY3454738

Experimental group

Description:

500 milligram (mg) LY3454738 administered intravenously (IV).

Treatment:

Drug: LY3454738

Placebo

Placebo Comparator group

Description:

Placebo administered IV.

Treatment:

Drug: Placebo