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A Study of LY3471851 in Participants With Eczema

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: NCT04081350
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 5, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE December 4, 2019
Estimated Primary Completion Date January 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Study Completion (up to Week 48) ]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 [ Time Frame: Postdose on Day 1 through Day 14 ]
    PK: AUC of LY3471851
  • PK: Trough Concentrations (Ctrough) of LY3471851 [ Time Frame: Week 12 ]
    PK: Ctrough of LY3471851
  • PK: Maximum Concentration (Cmax) of LY3471851 [ Time Frame: Postdose on Day 1 through Day 14 ]
    PK: Cmax of LY3471851
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3471851 in Participants With Eczema
Official Title  ICMJE A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis
Brief Summary The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: LY3471851
    Administered SC
    Other Name: NKTR-358
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Active Comparator: LY3471851
    LY3471851 administered subcutaneously (SC)
    Intervention: Drug: LY3471851
  • Placebo Comparator: Placebo
    Placebo administered SC
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 26, 2021
Estimated Primary Completion Date January 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months
  • Have active AD according to study specific criteria
  • Be willing and able to undergo skin biopsies

Exclusion Criteria:

  • Have received certain topical medications for AD within 14 days prior to baseline
  • Have received certain systemic medications for AD within 4 weeks prior to baseline
  • Have received LY3471851 previously
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04081350
Other Study ID Numbers  ICMJE 17240
J1P-MC-KFAD ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Nektar Therapeutics
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP