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A Study of LY3041658 in Participants With Skin Diseases

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ClinicalTrials.gov Identifier: NCT02896868
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Diseases Psoriasis Drug: LY3041658 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases
Actual Study Start Date : November 8, 2016
Actual Primary Completion Date : March 19, 2019
Actual Study Completion Date : March 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3041658
LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
 Drug: LY3041658
Administered IV.
Placebo Comparator: Placebo
Placebo administered IV once every two weeks over 6 weeks (four doses).
 Drug: Placebo
Administered IV.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896868


Locations
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United States, California
Parexel Early Phase Unit at Glendale
Glendale, California, United States, 91206-4140
United States, Indiana
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States, 46256
United States, Maryland
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, United States, 21225
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02896868    
Other Study ID Numbers: 15165
I7P-MC-DSAB ( Other Identifier: Eli Lilly and Company )
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 1, 2019
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous