Clinical trial NCT04159701: A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7)
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score)
timeFrame: Week 12
measure: Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score)
timeFrame: Week 12
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738
timeFrame: 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
measure: PK: Maximum Concentration (Cmax) of LY3454738
timeFrame: 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
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Research, Inc
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group + Research Center
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Aventura
country: United States
facility: Florida Center for Allergy & Asthma Research Landman
state: Florida
city: Miami
country: United States
facility: Florida Center for Allergy & Asthma Research Rodicio
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida Asthma, Allergy and Immunology
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, P.S.C.
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
city: Saint Louis
country: United States
facility: Signature Allergy & Immunology
state: Missouri
city: Columbus
country: United States
facility: Optimed Research, LTD
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Hannover
country: Germany
facility: Medizinische Hochschule Hanover
state: Niedersachsen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Krakow
country: Poland
facility: Diamond Clinic
state: Malopolskie
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
state: Mazowieckie
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: