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

Sponsors

Lead Sponsor: Eli Lilly and Company

Collaborator: Nektar Therapeutics

Source Eli Lilly and Company
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.

Overall Status Recruiting
Start Date December 4, 2019
Completion Date July 12, 2022
Primary Completion Date July 12, 2022
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure 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 Baseline through Study Completion (up to Week 48)
Secondary Outcome
Measure Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 Postdose on Day 1 through Day 14
PK: Trough Concentrations (Ctrough) of LY3471851 Week 12
PK: Maximum Concentration (Cmax) of LY3471851 Postdose on Day 1 through Day 14
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: LY3471851

Description: Administered SC

Arm Group Label: LY3471851

Other Name: NKTR-358

Intervention Type: Drug

Intervention Name: Placebo

Description: Administered SC

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Overall Contact

Last Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email: [email protected]

Location
Facility: Status: Investigator:
Arkansas Research Trials, LLC | North Little Rock, Arkansas, 72117, United States Not yet recruiting Scott Dinehart Principal Investigator
California Dermatology & Clinical Research Institute | Encinitas, California, 92024, United States Recruiting 760-203-3839 Stacy R. Smith Principal Investigator
First OC Dermatology | Fountain Valley, California, 92708, United States Not yet recruiting Vivian Laquer Principal Investigator
Therapeutics Clinical Research | San Diego, California, 92123, United States Recruiting 858-571-6800 Neal D Bhatia Principal Investigator
Miami Dermatology and Laser Research | Miami, Florida, 33173, United States Not yet recruiting 305-279-6060 Jill S Waibel Principal Investigator
ForCare Clinical Research | Tampa, Florida, 33613-1244, United States Recruiting 813-264-2155 Seth Forman Principal Investigator
Medical Dermatology Specialists | Sandy Springs, Georgia, 30328, United States Recruiting +1 404-939-9220 Jamie Debra Weisman Principal Investigator
Dawes Fretzin Clinical Research Group, LLC | Indianapolis, Indiana, 46250, United States Recruiting 317-516-5030 Scott Alfred Fretzin Principal Investigator
Skin Sciences | Louisville, Kentucky, 40217, United States Recruiting 502-451-9000 Leon H Kircik Principal Investigator
Forefront Research | Louisville, Kentucky, 40241, United States Recruiting 502-585-9059 Cindy E Owen Principal Investigator
Clinical Research Institute of Michigan, LLC | Chesterfield, Michigan, 48047, United States Not yet recruiting Natalia Filipof Principal Investigator
Derm Center | Troy, Michigan, 48084, United States Recruiting 248-244-8448 George J Murakawa Principal Investigator
Central Dermatology PC | Saint Louis, Missouri, 63117, United States Recruiting 314-721-5565 Craig L Leonardi Principal Investigator
ActivMed Practices and Research | Portsmouth, New Hampshire, 03801, United States Recruiting 603-319-8863 Abel Jarell Principal Investigator
Remington-Davis, Inc | Columbus, Ohio, 43215, United States Recruiting 614-487-2560 Michelle C Chambers Principal Investigator
Unity Clinical Research | Oklahoma City, Oklahoma, 73118, United States Recruiting 405-606-3900 Jarad Levin Principal Investigator
Paddington Testing Company Inc | Philadelphia, Pennsylvania, 19103, United States Recruiting 215-563-7330 Lawrence C. Parish Principal Investigator
DermDox Centers for Dermatology | Sugarloaf, Pennsylvania, 18249, United States Recruiting 570-459-0029 Stephen M Schleicher Principal Investigator
Studies in Dermatology, LLC | Cypress, Texas, 77433, United States Not yet recruiting Lauren Campbell Principal Investigator
Rodgers Dermatology | Frisco, Texas, 75034, United States Recruiting 972-704-2400 Timothy G Rodgers Principal Investigator
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: LY3471851

Type: Active Comparator

Description: LY3471851 administered subcutaneously (SC)

Label: Placebo

Type: Placebo Comparator

Description: Placebo administered SC

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov