A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

Phase 2TerminatedNCT04159701

Eli Lilly and Company52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Spontaneous Urticaria

Interventions

LY3454738DRUG

Administered IV

PlaceboDRUG

Administered IV

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (25)

Outcomes

Primary Outcomes

Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)

The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF).

Time frame: Baseline, Week 12

Secondary Outcomes

Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)

The ISS7 is the sum of the daily ISS over a 7-day period and ranges from 0 to 21. The daily ISS is the average of the morning and evening ISS on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The baseline ISS7 is the sum of the daily ISS over the 7 days prior to the first treatment. A higher ISS or higher ISS7 indicates more severe itching. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF).

Time frame: Baseline, Week 12

Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7)

The HSS7 is the sum of the daily number of hives over a 7-day period and ranges from 0 to 21. The daily number of hives score (also called HSS) is the average of the morning and evening number of hive scores on a four-point scale of 0 (none), 1 (between 1 and 6 hives, inclusive), 2 (between 7 and 12 hives, inclusive), and 3 (greater than 12 hives). The baseline weekly HSS7 is the sum of the HSS over the 7 days prior to the first treatment. A higher HSS or higher HSS7 indicates a greater number of hives. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF).

Data from ClinicalTrials.gov

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