A Study of LY3471851 in Participants With Eczema

NCT ID: NCT04081350

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2022-06-24

Brief Summary

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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

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

LY3471851

Intervention Type DRUG

Administered SC

12 µg/kg LY3471851

Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.

Group Type ACTIVE_COMPARATOR

LY3471851

Intervention Type DRUG

Administered SC

24 µg/kg LY3471851

Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.

Group Type ACTIVE_COMPARATOR

LY3471851

Intervention Type DRUG

Administered SC

Placebo

Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3471851

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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NKTR-358

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Nektar Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Nektar Therapeutics

Locations

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Arkansas Research Trials, LLC

North Little Rock, Arkansas, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Miami Dermatology and Laser Research

Miami, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Medical Dermatology Specialists

Sandy Springs, Georgia, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

Skin Sciences

Louisville, Kentucky, United States

Site Status

Derm Center

Troy, Michigan, United States

Site Status

ActivMed Practices and Research

Portsmouth, New Hampshire, United States

Site Status

Remington-Davis, Inc

Columbus, Ohio, United States

Site Status

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Paddington Testing Company Inc

Philadelphia, Pennsylvania, United States

Site Status

DermDox Centers for Dermatology

Sugarloaf, Pennsylvania, United States

Site Status

Studies in Dermatology, LLC

Cypress, Texas, United States

Site Status

Rodgers Dermatology

Frisco, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Complete Dermatology

Sugar Land, Texas, United States

Site Status

Countries

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United States

References

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Silverberg JI, Rosmarin D, Chovatiya R, Bieber T, Schleicher S, Beck L, Gooderham M, Chaudhry S, Fanton C, Yu D, Levy J, Liu Y, Miyazaki T, Tagliaferri M, Schmitz C, Nirula A, Kotzin B, Zalevsky J. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024 Oct 25;15(1):9230. doi: 10.1038/s41467-024-53384-1.

Reference Type DERIVED
PMID: 39455575 (View on PubMed)

Related Links

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https://trials.lillytrialguide.com/en-US/trial/3Ex7XDC7Soi22zSKKaGtrA

A Study of LY3471851 in Participants With Eczema

Other Identifiers

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J1P-MC-KFAD

Identifier Type: OTHER

Identifier Source: secondary_id

17240

Identifier Type: -

Identifier Source: org_study_id

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