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Completed

NCT Number: NCT02896868

A Study of LY3041658 in Participants With Skin Diseases

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.

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Key information

Conditions

Skin Diseases Psoriasis Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Unit at Glendale, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3041658

Drug

Administered IV.

Placebo

Drug

Administered IV.

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

    Time frame: Dosing Day 1 through Day 127

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658

    Time frame: Dosing Day 1 through Day 127

  2. 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

  3. Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658

    Time frame: Dosing Day 1 through Day 127

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2016
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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