A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

Chronic Spontaneous Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04159701
• Other study ID #: 17480
• Secondary ID: J1B-MC-FRCF2019-
• Status: Terminated
• Phase: Phase 2
• Start date: November 15, 2019
• Est. completion date: February 24, 2021

Study information

• Verified date: February 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• LY3454738
Administered IV
• Placebo
Administered IV

Locations

Country	Name	City	State
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Rothhaar Studien GmbH	Berlin
Germany	Medizinische Hochschule Hanover	Hannover	Niedersachsen
Germany	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz	Mainz	Rheinland-Pfalz
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Poland	Diamond Clinic	Krakow	Malopolskie
Poland	Centrum Medyczne Evimed	Warszawa	Mazowieckie
United States	Florida Center for Allergy & Asthma Research Landman	Aventura	Florida
United States	Kern Research, Inc	Bakersfield	California
United States	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Optimed Research, LTD	Columbus	Ohio
United States	First OC Dermatology	Fountain Valley	California
United States	Antelope Valley Clinical Trials	Lancaster	California
United States	California Allergy and Asthma Medical Group + Research Center	Los Angeles	California
United States	Florida Center for Allergy & Asthma Research Rodicio	Miami	Florida
United States	Miami Dermatology and Laser Research	Miami	Florida
United States	Allergy & Asthma Specialists, P.S.C.	Owensboro	Kentucky
United States	Northwest Research Center	Portland	Oregon
United States	Allergy & Asthma Consultants	Redwood City	California
United States	Signature Allergy & Immunology	Saint Louis	Missouri
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	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Week 12
Secondary	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).	Baseline, Week 12
Secondary	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).	Baseline, Week 12
Secondary	Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) =6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score)	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.	Week 12
Secondary	Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) =6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score)	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.	Week 12
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738	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
Secondary	PK: Maximum Concentration (Cmax) 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

External Links

•   A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria