A Study of LY3041658 in Participants With Skin Diseases

NCT ID: NCT02896868

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-08

Study Completion Date

2019-03-19

Brief Summary

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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

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Conditions

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Skin Diseases Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3041658

LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).

Group Type EXPERIMENTAL

LY3041658

Intervention Type DRUG

Administered IV.

Placebo

Placebo administered IV once every two weeks over 6 weeks (four doses).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV.

Interventions

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LY3041658

Administered IV.

Intervention Type DRUG

Placebo

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Parexel Early Phase Unit at Glendale

Glendale, California, United States

Site Status

Dawes Fretzin Clinical Research

Indianapolis, Indiana, United States

Site Status

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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https://www.lillytrialguide.com/en-US/studies/skin-disease/DSAB#?postal=

Click here for more information about this study: A Study of LY3041658 in Participants With Skin Diseases

Other Identifiers

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I7P-MC-DSAB

Identifier Type: OTHER

Identifier Source: secondary_id

15165

Identifier Type: -

Identifier Source: org_study_id

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