A Study of LY3041658 in Participants With Skin Diseases
A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases
2 other identifiers
interventional
60
1 country
5
Brief Summary
The main purpose of this study is to investigate the safety and tolerability of the study drug known as LY3041658 in participants with certain types of skin diseases. The study will measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127 days for each participant, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2016
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedStudy Start
First participant enrolled
November 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2019
CompletedMay 3, 2019
May 1, 2019
2.4 years
September 7, 2016
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Dosing Day 1 through Day 127
Secondary Outcomes (3)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Dosing Day 1 through Day 127
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658
Dosing Day 1 through Day 127
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658
Dosing Day 1 through Day 127
Study Arms (2)
LY3041658
EXPERIMENTALLY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
Placebo
PLACEBO COMPARATORPlacebo administered IV once every two weeks over 6 weeks (four doses).
Interventions
Eligibility Criteria
You may qualify if:
- Investigator confirmed diagnosis of certain skin diseases for at least 6 months.
- Active skin lesions that are not responding to standard therapies.
- Willing to undergo pre- and post-treatment skin biopsies of lesions.
You may not qualify if:
- \- Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Parexel Early Phase Unit at Glendale
Glendale, California, 91206-4140, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46256, United States
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, 21225, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
September 12, 2016
Study Start
November 8, 2016
Primary Completion
March 19, 2019
Study Completion
March 19, 2019
Last Updated
May 3, 2019
Record last verified: 2019-05-01