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A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

Primary Purpose

Chronic Spontaneous Urticaria

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3454738
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kern Research, Inc
  • First OC Dermatology
  • Antelope Valley Clinical Trials
  • California Allergy and Asthma Medical Group + Research Center
  • Allergy & Asthma Consultants
  • Florida Center for Allergy & Asthma Research Landman
  • Florida Center for Allergy & Asthma Research Rodicio
  • Miami Dermatology and Laser Research
  • Sarasota Clinical Research
  • ForCare Clinical Research
  • University of South Florida Asthma, Allergy and Immunology
  • Treasure Valley Medical Research
  • Allergy & Asthma Specialists, P.S.C.
  • Johns Hopkins Asthma and Allergy Center
  • Signature Allergy & Immunology
  • Optimed Research, LTD
  • Vital Prospects Clinical Research Institute, P.C.
  • Northwest Research Center
  • Medizinische Hochschule Hanover
  • Universitätsklinikum Münster
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
  • Charité Campus Virchow-Klinikum
  • Rothhaar Studien GmbH
  • Diamond Clinic
  • Centrum Medyczne Evimed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3454738

Placebo

Arm Description

500 milligram (mg) LY3454738 administered intravenously (IV).

Placebo administered IV.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
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.
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
PK: Maximum Concentration (Cmax) of LY3454738
PK: Maximum Concentration (Cmax) of LY3454738

Full Information

First Posted
November 8, 2019
Last Updated
February 14, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04159701
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated for lack of efficacy after an interim analysis was performed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3454738
Arm Type
Experimental
Arm Description
500 milligram (mg) LY3454738 administered intravenously (IV).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV.
Intervention Type
Drug
Intervention Name(s)
LY3454738
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7)
Description
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).
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7)
Description
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).
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7)
Description
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).
Time Frame
Baseline, Week 12
Title
Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score)
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score)
Description
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.
Time Frame
Week 12
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738
Description
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738
Time Frame
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
Title
PK: Maximum Concentration (Cmax) of LY3454738
Description
PK: Maximum Concentration (Cmax) of LY3454738
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Kern Research, Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
California Allergy and Asthma Medical Group + Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Allergy & Asthma Consultants
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Florida Center for Allergy & Asthma Research Landman
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Florida Center for Allergy & Asthma Research Rodicio
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Miami Dermatology and Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
University of South Florida Asthma, Allergy and Immunology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Allergy & Asthma Specialists, P.S.C.
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Johns Hopkins Asthma and Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Signature Allergy & Immunology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Optimed Research, LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Northwest Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Medizinische Hochschule Hanover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Diamond Clinic
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Centrum Medyczne Evimed
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/
Links:
URL
https://www.lillytrialguide.com/en-US/studies/hives/FRCF#?postal=
Description
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

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A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

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