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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: Placebo; Drug: LY3454738

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Berlin, Germany, 10117
    • Charité Campus Virchow-Klinikum
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hanover
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Universitätsklinikum Münster
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
• Poland
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-559
      • Diamond Clinic
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-625
      • Centrum Medyczne Evimed
• United States
  • California
    • Bakersfield, California, United States, 93301
      • Kern Research, Inc
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Lancaster, California, United States, 93534
      • Antelope Valley Clinical Trials
    • Los Angeles, California, United States, 90025
      • California Allergy and Asthma Medical Group + Research Center
    • Redwood City, California, United States, 94063
      • Allergy & Asthma Consultants
  • Florida
    • Aventura, Florida, United States, 33180
      • Florida Center for Allergy & Asthma Research Landman
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Research
    • Miami, Florida, United States, 33173
      • Florida Center for Allergy & Asthma Research Rodicio
    • Sarasota, Florida, United States, 34239
      • Sarasota Clinical Research
    • Tampa, Florida, United States, 33613-1244
      • ForCare Clinical Research
    • Tampa, Florida, United States, 33613
      • University of South Florida Asthma, Allergy and Immunology
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Allergy & Asthma Specialists, P.S.C.
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Asthma and Allergy Center
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Signature Allergy & Immunology
  • Ohio
    • Columbus, Ohio, United States, 43235
      • Optimed Research, LTD
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Oregon
    • Portland, Oregon, United States, 97202
      • Northwest Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3454738; 500 milligram (mg) LY3454738 administered intravenously (IV).	Drug: LY3454738; Administered IV
Placebo Comparator: Placebo; Placebo administered IV.	Drug: Placebo; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria
• Other Study ID Numbers: 17480; J1B-MC-FRCF (Other Identifier: Eli Lilly and Company); 2019-002495-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No