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A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159701
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Drug: LY3454738 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : March 3, 2021
Estimated Study Completion Date : August 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Experimental: LY3454738
LY3454738 administered intravenously (IV).
Drug: LY3454738
Administered IV

Placebo Comparator: Placebo
Placebo administered IV.
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Mean Change from Baseline in Urticaria Activity Score Over 7 Days (UAS7) [ Time Frame: Baseline, Week 12 ]
    Mean Change from Baseline in UAS7


Secondary Outcome Measures :
  1. Mean Change from Baseline in Itch Severity Score Over 7 Days (ISS7) [ Time Frame: Baseline, Week 12 ]
    Mean Change from Baseline in ISS7

  2. Mean Change from Baseline in Hives Severity Score Over 7 Days (HSS7) [ Time Frame: Baseline, Week 12 ]
    Mean Change from Baseline in HSS7

  3. Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 [ Time Frame: Week 12 ]
    Percentage of Participants Achieving UAS7 ≤6

  4. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3454738 [ Time Frame: Baseline through Week 34 ]
    PK: AUC of LY3454738

  5. PK: Maximum Concentration (Cmax) of LY3454738 [ Time Frame: Baseline through Week 34 ]
    PK: Cmax of LY3454738



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159701


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04159701    
Other Study ID Numbers: 17480
J1B-MC-FRCF ( Other Identifier: Eli Lilly and Company )
2019-002495-13 ( EudraCT Number )
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases