Clinical trial NCT04081350: A Study of LY3471851 in Participants With Eczema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2019-09-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Study Completion (up to Week 48)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
timeFrame: Postdose on Day 1 through Day 14
measure: PK: Trough Concentrations (Ctrough) of LY3471851
timeFrame: Week 12
measure: PK: Maximum Concentration (Cmax) of LY3471851
timeFrame: Postdose on Day 1 through Day 14
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Arkansas Research Trials, LLC
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Sandy Springs
country: United States
facility: Medical Dermatology Specialists
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences
state: Kentucky
city: Troy
country: United States
facility: Derm Center
state: Michigan
city: Portsmouth
country: United States
facility: ActivMed Practices and Research
state: New Hampshire
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Company Inc
state: Pennsylvania
city: Sugarloaf
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Cypress
country: United States
facility: Studies in Dermatology, LLC
state: Texas
city: Frisco
country: United States
facility: Rodgers Dermatology
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: