A Study of LY3471851 in Participants With Eczema

Phase 1

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: Placebo; Drug: LY3471851

• Registration Number: NCT04081350
• Lead Sponsor: Nektar Therapeutics

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 available

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Study Start: 2019-12-04
• Primary Completion: 2022-06-24
• Study Completion: 2022-06-24
• Status Verified: 2024-02-15
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks.
10 µg/kg LY3471851	LY3471851	Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks.
12 µg/kg LY3471851	LY3471851	Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
24 µg/kg LY3471851	LY3471851	Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	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

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

Trial Locations

Locations (20)

Arkansas Research Trials, LLC; 🇺🇸 North Little Rock, Arkansas, United States

California Dermatology & Clinical Research Institute; 🇺🇸 Encinitas, California, United States

Center For Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Miami Dermatology and Laser Research; 🇺🇸 Miami, Florida, United States

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

Medical Dermatology Specialists; 🇺🇸 Sandy Springs, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Skin Sciences; 🇺🇸 Louisville, Kentucky, United States

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