We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04081350
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : January 26, 2023
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: LY3471851 Drug: Placebo Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : December 4, 2019
Actual Primary Completion Date : June 24, 2022
Actual Study Completion Date : June 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: LY3471851
LY3471851 administered subcutaneously (SC)
 Drug: LY3471851
Administered SC
Other Name: NKTR-358
Placebo Comparator: Placebo
Placebo administered SC
 Drug: Placebo
Administered SC


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. PK: Trough Concentrations (Ctrough) of LY3471851 [ Time Frame: Week 12 ]
    PK: Ctrough of LY3471851

  3. PK: Maximum Concentration (Cmax) of LY3471851 [ Time Frame: Postdose on Day 1 through Day 14 ]
    PK: Cmax of LY3471851


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04081350


Locations
Show Show 20 study locations
Sponsors and Collaborators
Eli Lilly and Company
Nektar Therapeutics
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04081350    
Other Study ID Numbers: 17240
J1P-MC-KFAD ( Other Identifier: Eli Lilly and Company )
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 15, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases