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A Safety Study of LY3462817 in Participants With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04152382
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : November 5, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. The study will last up to one year and one month for each participant.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: LY3462817 - IV Drug: LY3462817 - SC Drug: Placebo - IV Drug: Placebo - SC Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 in Patients With Psoriasis
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : December 12, 2022
Estimated Study Completion Date : December 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: LY3462817 - Intravenous (IV)
LY3462817 administered as IV infusions.
Drug: LY3462817 - IV
Administered IV

Placebo Comparator: Placebo - IV
Placebo administered as IV infusions.
Drug: Placebo - IV
Administered IV

Experimental: LY3462817 - Subcutaneous (SC)
LY3462817 administered as SC injections. (SC administration is discretionary/optional.)
Drug: LY3462817 - SC
Administered SC

Placebo Comparator: Placebo - SC
Placebo administered as SC injections. (SC administration is discretionary/optional.)
Drug: Placebo - SC
Administered SC




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: Baseline through Final Follow-up (up to Week 52) ]
    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 [ Time Frame: Baseline through Final Follow-up (up to Week 52) ]
    PK: Cave of LY3462817



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Participants must have been diagnosed with psoriasis for at least 6 months
  • Participants must have active psoriasis plaques
  • Participants must be willing and able to have skin biopsies (small samples of skin removed for testing)

Exclusion Criteria:

  • Participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (Day 1)
  • Participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline

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): NCT04152382


Locations
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United States, California
Dermatology Associates - Los Angeles
Los Angeles, California, United States, 90045
United States, Florida
Advanced Pharma Clinical Research
Miami, Florida, United States, 33175
Avita Clinical Research
Tampa, Florida, United States, 33613
United States, Georgia
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
United States, Louisiana
Meridian Clinical Research
Baton Rouge, Louisiana, United States, 70808
United States, Missouri
Central Dermatology PC
Saint Louis, Missouri, United States, 63117
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Canada, Ontario
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, Canada, L4M 7G1
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada, N2J 1C4
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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04152382    
Other Study ID Numbers: 17218
J1A-MC-KDAC ( Other Identifier: Eli Lilly and Company )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases