Study Stopped
The study was terminated for lack of efficacy after an interim analysis was performed
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
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
3 other identifiers
interventional
52
3 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2019
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2021
CompletedResults Posted
Study results publicly available
March 11, 2022
CompletedMarch 11, 2022
February 1, 2022
1.3 years
November 8, 2019
February 14, 2022
February 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)
Baseline, Week 12
Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7)
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
Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score)
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
- +1 more secondary outcomes
Study Arms (2)
LY3454738
EXPERIMENTAL500 milligram (mg) LY3454738 administered intravenously (IV).
Placebo
PLACEBO COMPARATORPlacebo administered IV.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Kern Research, Inc
Bakersfield, California, 93301, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Antelope Valley Clinical Trials
Lancaster, California, 93534, United States
California Allergy and Asthma Medical Group + Research Center
Los Angeles, California, 90025, United States
Allergy & Asthma Consultants
Redwood City, California, 94063, United States
Florida Center for Allergy & Asthma Research Landman
Aventura, Florida, 33180, United States
Florida Center for Allergy & Asthma Research Rodicio
Miami, Florida, 33173, United States
Miami Dermatology and Laser Research
Miami, Florida, 33173, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
University of South Florida Asthma, Allergy and Immunology
Tampa, Florida, 33613, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
Signature Allergy & Immunology
St Louis, Missouri, 63141, United States
Optimed Research, LTD
Columbus, Ohio, 43235, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Northwest Research Center
Portland, Oregon, 97202, United States
Medizinische Hochschule Hanover
Hanover, Lower Saxony, 30625, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Charité Campus Virchow-Klinikum
Berlin, 10117, Germany
Rothhaar Studien GmbH
Berlin, 10783, Germany
Diamond Clinic
Krakow, Lesser Poland Voivodeship, 31-559, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated for lack of efficacy after an interim analysis was performed.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2019
First Posted
November 12, 2019
Study Start
November 15, 2019
Primary Completion
February 24, 2021
Study Completion
February 24, 2021
Last Updated
March 11, 2022
Results First Posted
March 11, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.