A Study of LY3471851 in Participants With Eczema

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081350
• Other study ID #: 17240
• Secondary ID: J1P-MC-KFAD
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2019
• Est. completion date: June 24, 2022

Study information

• Verified date: February 15, 2024
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• LY3471851
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Remington-Davis, Inc	Columbus	Ohio
United States	Studies in Dermatology, LLC	Cypress	Texas
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Center For Dermatology Clinical Research, Inc.	Fremont	California
United States	Rodgers Dermatology	Frisco	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Skin Sciences	Louisville	Kentucky
United States	Miami Dermatology and Laser Research	Miami	Florida
United States	Arkansas Research Trials, LLC	North Little Rock	Arkansas
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Paddington Testing Company Inc	Philadelphia	Pennsylvania
United States	ActivMed Practices and Research	Portsmouth	New Hampshire
United States	Progressive Clinical Research	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Medical Dermatology Specialists	Sandy Springs	Georgia
United States	Clinical Science Institute	Santa Monica	California
United States	Complete Dermatology	Sugar Land	Texas
United States	DermDox Centers for Dermatology	Sugarloaf	Pennsylvania
United States	ForCare Clinical Research	Tampa	Florida
United States	Derm Center	Troy	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Nektar Therapeutics	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851	PK: AUC of LY3471851	Postdose on Day 1 through Day 14
Secondary	PK: Trough Concentrations (Ctrough) of LY3471851	PK: Ctrough of LY3471851	Week 12
Secondary	PK: Maximum Concentration (Cmax) of LY3471851	PK: Cmax of LY3471851	Postdose on Day 1 through Day 14

External Links

•   A Study of LY3471851 in Participants With Eczema