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A Study of LY3471851 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119557
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with psoriasis. The study will last up to 48 weeks and may include up to 23 visits to the study center.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: LY3471851 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Psoriasis
Actual Study Start Date : November 26, 2019
Estimated Primary Completion Date : January 26, 2021
Estimated Study Completion Date : January 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: LY3471851
LY3471851 administered subcutaneously (SC)
Drug: LY3471851
Administered SC
Other Name: NKTR-358

Placebo Comparator: Placebo
Placebo administered SC
Drug: Placebo
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 Study Completion (up to Week 48) ]
    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): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 [ Time Frame: Postdose on Day 1 through Day 14 ]
    PK: AUC of LY3471851

  2. PK: Trough Concentrations (Ctrough) of LY3471851 [ Time Frame: Week 12 ]
    PK: Ctrough of LY3471851

  3. PK: Maximum Concentration (Cmax) of LY3471851 [ Time Frame: Postdose on Day 1 through Day 14 ]
    PK: Cmax of LY3471851



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 to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a confirmed diagnosis of psoriasis for at least 6 months
  • Have active psoriasis plaques according to study- specific criteria
  • Be willing and able to undergo skin biopsies

Exclusion Criteria:

  • Have received certain topical medications for psoriasis within 14 days prior to baseline
  • Have received certain systemic medications for psoriasis within 4 weeks prior to baseline
  • Have received LY3471851 previously

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): NCT04119557


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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United States, California
California Dermatology and Clinical Research Institute Not yet recruiting
Encinitas, California, United States, 92024
Contact    760-203-3839      
Principal Investigator: Stacy R. Smith         
Therapeutics Clinical Research Not yet recruiting
San Diego, California, United States, 92123
Contact    858-571-6800      
Principal Investigator: Neal D Bhatia         
United States, Florida
Florida Academic Dermatology Centers Recruiting
Coral Gables, Florida, United States, 33134
Contact    305-324-2110      
Principal Investigator: Francisco A Kerdel         
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
Contact    813-264-2155      
Principal Investigator: Seth B Forman         
United States, Georgia
Medical Dermatology Specialists Recruiting
Sandy Springs, Georgia, United States, 30328
Contact    +1 404-939-9220      
Principal Investigator: Jamie Debra Weisman         
United States, Idaho
Treasure Valley Dermatology Recruiting
Boise, Idaho, United States, 83713
Contact    208-377-8653      
Principal Investigator: Ryan Harris         
United States, Indiana
Dawes Fretzin Clinical Research Recruiting
Indianapolis, Indiana, United States, 46250
Contact    317-516-5030      
Principal Investigator: Scott A Fretzin         
United States, Kentucky
Skin Sciences Not yet recruiting
Louisville, Kentucky, United States, 40217
Contact    502-451-9000      
Principal Investigator: Leon H Kircik         
Dermatology Specialist Not yet recruiting
Louisville, Kentucky, United States, 40241
Contact    502-585-9059      
Principal Investigator: Cindy E Owen         
United States, Michigan
Derm Center Recruiting
Troy, Michigan, United States, 48084
Contact    248-244-8448      
Principal Investigator: George J Murakawa         
United States, Missouri
Central Dermatology PC Not yet recruiting
Saint Louis, Missouri, United States, 63117
Contact    314-721-5565      
Principal Investigator: Craig L Leonardi         
United States, New Hampshire
ActivMed Practices & Research, Inc Not yet recruiting
Portsmouth, New Hampshire, United States, 03801
Contact    603-319-8863      
Principal Investigator: Abel Jarell         
United States, Oklahoma
Unity Clinical Research Recruiting
Oklahoma City, Oklahoma, United States, 73118
Contact    405-606-3900      
Principal Investigator: Jarad Levin         
United States, Pennsylvania
Paddington Testing Company Inc Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact    215-563-7330      
Principal Investigator: Lawrence C. Parish         
DermDox Centers for Dermatology Recruiting
Sugarloaf, Pennsylvania, United States, 18249
Contact    570-459-0029      
Principal Investigator: Stephen M Schleicher         
United States, Texas
Rodgers Dermatology Recruiting
Frisco, Texas, United States, 75034
Contact    972-704-2400      
Principal Investigator: Timothy G Rodgers         
Sponsors and Collaborators
Eli Lilly and Company
Nektar Therapeutics
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: NCT04119557     History of Changes
Other Study ID Numbers: 17239
J1P-MC-KFAC ( Other Identifier: Eli Lilly and Company )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 1, 2019
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