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NCT02896868 Clinical Trial

A Study of LY3041658 in Participants With Skin Diseases

Psoriasis Clinical Trial

Official title:
A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02896868
Other study ID # 15165
Secondary ID I7P-MC-DSAB
Status Completed
Phase Phase 1
First received
Last updated
Start date November 8, 2016
Est. completion date March 19, 2019

Study information
Verified date May 1, 2019
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 19, 2019
Est. primary completion date March 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LY3041658
Administered IV.
• Placebo
Administered IV.

Locations
Country Name City State
United States PAREXEL-Phase 1 Baltimore Harbor Hospital Center Baltimore Maryland
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Duke University Medical Center Durham North Carolina
United States Parexel Early Phase Unit at Glendale Glendale California
United States Dawes Fretzin Clinical Research Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
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 Dosing Day 1 through Day 127
Secondary Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658 Dosing Day 1 through Day 127
Secondary 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
Secondary Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658 Dosing Day 1 through Day 127
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