- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418493
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis
The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).
This is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Glendale, California, United States, 91206-4140
- Parexel Early Phase Unit at Glendale
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Maryland
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Baltimore, Maryland, United States, 21225
- PAREXEL-Phase 1 Baltimore Harbor Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Healthy Participants
- Are overtly healthy males or females, as determined by medical history and physical examination
- Females must be of non-childbearing potential
- Are between 18 and 64 years of age, inclusive, at screening
- Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Psoriasis Participants:
- Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline
- Meet psoriasis disease activity criteria
- Are at least 18 years of age
- Have a minimum body weight of 50 kilograms (kg)
Exclusion Criteria:
Healthy and Psoriasis Participants
- Have known or ongoing neuropsychiatric disorders
- Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study
- Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline
- Show evidence of active or latent tuberculosis (TB)
- Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data
Psoriasis Participants Only:
- Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)
- Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval
- Have received systemic nonbiologic psoriasis therapy within 28 days of baseline
- Have received topical psoriasis treatment within 14 days of baseline
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo (Part A)
Placebo matching LY3316531 administered IV.
|
Administered IV.
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Experimental: LY3316531 (Part A)
Participants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC).
|
Administered IV.
Administered SC.
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Experimental: LY3316531 (Part B)
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
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Administered IV.
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Placebo Comparator: Placebo (Part B)
Placebo matching LY3316531 administered IV.
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Administered IV.
|
Experimental: LY3316531 (Part C)
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
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Administered IV.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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: Pre-dose up to 1 year after administration of study drug
|
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following:
|
Pre-dose up to 1 year after administration of study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
Time Frame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
|
PK: Cmax of LY3316531.
Under time frame, hours was abbreviated as "hrs."
|
Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
|
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
Time Frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
|
PK: Cmax of LY3316531 following the Day 57 dose.
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Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
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Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
Time Frame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
|
PK: Cmax of LY3316531.
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Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
|
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
Time Frame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
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Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
|
Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
|
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau
Time Frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
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AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.
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Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
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Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
Time Frame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
|
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
|
Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16666
- I9H-MC-FFAA (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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