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OpenTrials
Completed

NCT Number: NCT04081350

A Study of LY3471851 in Participants With Eczema

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arkansas Research Trials, LLC, North Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3471851

Drug

Administered SC

Other names: NKTR-358

Placebo

Drug

Administered SC

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2019
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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