A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks.

Key facts

Study ID

NCT02543918

Run by

Eli Lilly and Company

People needed

84

Starts

2015-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males and females without compromised immune system
• Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)

You may not qualify if…

• Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists
• Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
• Have known allergy or hypersensitivity to any biologic therapy
• Past vaccination allergy or Arthus-type hypersensitivity
• Received a tetanus toxoid-containing vaccine within the last 5 years
• Severe allergic reaction to Boostrix
• Allergic to latex
• Have been immunized with pneumococcal vaccine
• Known hypogammaglobulinemia
• History of Guillain-Barre Syndrome
• Active infectious disease
• Had a live vaccination within 1 year prior to screening, or intend to have a live vaccination during the course of the study
• Evidence of a significant uncontrolled neuropsychiatric disorder -
• Have a score of 3 on Item 12 of the Quick Inventory of Depressive Symptomatology-Self Report (16 Items) at screening
• Evidence of Human Immunodeficiency Virus infection, Hepatitis C, B
• Had symptomatic herpes zoster within 3 months of screening
• Women who are lactating

Where it is running

• Covance — Daytona Beach, Florida, United States
• Covance — Evansville, Indiana, United States
• Covance — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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