A Study of LY3471851 in Participants With Eczema

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Placebo; Drug: LY3471851

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials, LLC
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fremont, California, United States, 94538
      • Center For Dermatology Clinical Research, Inc.
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Research
    • Tampa, Florida, United States, 33613-1244
      • ForCare Clinical Research
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Medical Dermatology Specialists
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences
  • Michigan
    • Troy, Michigan, United States, 48084
      • Derm Center
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices and Research
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company Inc
    • Sugarloaf, Pennsylvania, United States, 18249
      • DermDox Centers for Dermatology
  • Texas
    • Cypress, Texas, United States, 77433
      • Studies in Dermatology, LLC
    • Frisco, Texas, United States, 75034
      • Rodgers Dermatology
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • Sugar Land, Texas, United States, 77478
      • Complete Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10 µg/kg LY3471851; Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks.	Drug: LY3471851; Administered SC; Other Names: NKTR-358
Active Comparator: 12 µg/kg LY3471851; Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.	Drug: LY3471851; Administered SC; Other Names: NKTR-358
Active Comparator: 24 µg/kg LY3471851; Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.	Drug: LY3471851; Administered SC; Other Names: NKTR-358
Placebo Comparator: Placebo; Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks.	Drug: Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Study Completion (up to Week 48)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851	PK: AUC of LY3471851	Postdose on Day 1 through Day 14
PK: Trough Concentrations (Ctrough) of LY3471851	PK: Ctrough of LY3471851	Week 12
PK: Maximum Concentration (Cmax) of LY3471851	PK: Cmax of LY3471851	Postdose on Day 1 through Day 14

Collaborators and Investigators

• Sponsor: Nektar Therapeutics
• Collaborators: Eli Lilly and Company
• Investigators: Study Director: Study Director, Nektar Therapeutics

Publications and helpful links

Helpful Links

• A Study of LY3471851 in Participants With Eczema

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 15, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: 17240; J1P-MC-KFAD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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