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
Overview
- Phase
- Phase 2
- Intervention
- LY3454738
- Conditions
- Chronic Spontaneous Urticaria
- Sponsor
- Eli Lilly and Company
- Enrollment
- 52
- Locations
- 25
- Primary Endpoint
- Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
LY3454738
500 milligram (mg) LY3454738 administered intravenously (IV).
Intervention: LY3454738
Placebo
Placebo administered IV.
Intervention: Placebo
Outcomes
Primary Outcomes
Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)
Time Frame: Baseline, Week 12
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).
Secondary Outcomes
- Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)(Baseline, Week 12)
- Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score)(Week 12)
- Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7)(Baseline, Week 12)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738(Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up)
- PK: Maximum Concentration (Cmax) of LY3454738(Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up)
- Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score)(Week 12)