A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Drug: LY3454738Drug: Placebo
- Registration Number
- NCT04159701
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description LY3454738 LY3454738 500 milligram (mg) LY3454738 administered intravenously (IV). Placebo Placebo Placebo administered IV.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) 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 Outcome Measures
Name Time Method Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) Baseline, Week 12 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).
Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score) 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.
Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) Baseline, Week 12 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).
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 Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC \[0-336h\]) of LY3454738
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 PK: Maximum Concentration (Cmax) of LY3454738
Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score) 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.
Trial Locations
- Locations (25)
California Allergy and Asthma Medical Group + Research Center
🇺🇸Los Angeles, California, United States
Miami Dermatology and Laser Research
🇺🇸Miami, Florida, United States
Kern Research, Inc
🇺🇸Bakersfield, California, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Antelope Valley Clinical Trials
🇺🇸Lancaster, California, United States
Allergy & Asthma Consultants
🇺🇸Redwood City, California, United States
Florida Center for Allergy & Asthma Research Landman
🇺🇸Aventura, Florida, United States
Florida Center for Allergy & Asthma Research Rodicio
🇺🇸Miami, Florida, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
University of South Florida Asthma, Allergy and Immunology
🇺🇸Tampa, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Allergy & Asthma Specialists, P.S.C.
🇺🇸Owensboro, Kentucky, United States
Johns Hopkins Asthma and Allergy Center
🇺🇸Baltimore, Maryland, United States
Signature Allergy & Immunology
🇺🇸Saint Louis, Missouri, United States
Optimed Research, LTD
🇺🇸Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
Medizinische Hochschule Hanover
🇩🇪Hannover, Niedersachsen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Rothhaar Studien GmbH
🇩🇪Berlin, Germany
Diamond Clinic
🇵🇱Krakow, Malopolskie, Poland
Centrum Medyczne Evimed
🇵🇱Warszawa, Mazowieckie, Poland
Northwest Research Center
🇺🇸Portland, Oregon, United States