A Study of LY3041658 in Participants With Skin Diseases

Phase 1

Completed

• Conditions: Skin Diseases; Psoriasis
• Interventions: Drug: LY3041658; Drug: Placebo

• Registration Number: NCT02896868
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-12
• Study Start: 2016-11-08
• Primary Completion: 2019-03-19
• Study Completion: 2019-03-19
• Status Verified: 2019-05-01
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

• Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3041658	LY3041658	LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
Placebo	Placebo	Placebo administered IV once every two weeks over 6 weeks (four doses).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Parexel Early Phase Unit at Glendale; 🇺🇸 Glendale, California, United States

Dawes Fretzin Clinical Research; 🇺🇸 Indianapolis, Indiana, 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