Back to resultsA Study of LY3041658 in Participants With Skin Diseases
Primary Purpose
Skin Diseases, Psoriasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3041658
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Skin Diseases
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.
Sites / Locations
- Parexel Early Phase Unit at Glendale
- Dawes Fretzin Clinical Research
- PAREXEL-Phase 1 Baltimore Harbor Hospital Center
- Duke University Medical Center
- Altoona Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY3041658
Placebo
Arm Description
LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
Placebo administered IV once every two weeks over 6 weeks (four doses).
Outcomes
Primary Outcome Measures
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02896868
Brief Title
A Study of LY3041658 in Participants With Skin Diseases
Official Title
A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
May 1, 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Psoriasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3041658
Arm Type
Experimental
Arm Description
LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV once every two weeks over 6 weeks (four doses).
Intervention Type
Drug
Intervention Name(s)
LY3041658
Intervention Description
Administered IV.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame
Dosing Day 1 through Day 127
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Time Frame
Dosing Day 1 through Day 127
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658
Time Frame
Dosing Day 1 through Day 127
Title
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658
Time Frame
Dosing Day 1 through Day 127
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Parexel Early Phase Unit at Glendale
City
Glendale
State/Province
California
ZIP/Postal Code
91206-4140
Country
United States
Facility Name
Dawes Fretzin Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.lillytrialguide.com/en-US/studies/skin-disease/DSAB#?postal=
Description
Click here for more information about this study: A Study of LY3041658 in Participants With Skin Diseases
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