A Study in Participants With Moderate to Severe Psoriasis

Study summary

The primary purpose for this study is to help answer the following research questions * The safety of ixekizumab (LY2439821) and any side effects that might be associated with it. * Whether ixekizumab can help participants with Psoriasis. * How much ixekizumab should be given to participants.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIxekizumab and Placebo

The study team can explain what participation involves.

Who it may be forPsoriasis

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 24, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?34 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Eli Lilly and Company
Interventions being studied: Biological: Ixekizumab; Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Common to Both Part A:
Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization.
Participant is a candidate for systemic therapy
Participant has a Static Physician's Global Assessment (sPGA) score of at least 3 at screening and at randomization Inclusion Criterion Specific to Part B
Participant has completed the treatment period for part A (at least through week 20) Inclusion Criterion Specific to Part C
Participant has completed the treatment period for part B

Reasons someone may not be able to joinExclusion criteria

Common to Part A, B and C:
Participant has pustular, erythrodermic and/or guttate forms of psoriasis
Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry
Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept \>28 days, infliximab or adalimumab \>56 days, alefacept \>60 days, ustekinumab \>8 months, or any other biologic agent/monoclonal antibody \>5 half-lives prior to baseline
Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A \[PUVA\] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 \[mild, such as desonide\] or 7 \[least potent, such as hydrocortisone\] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia)
Participant has donated more than 500 mL of blood within the last month
Participant has another serious disorder or illness
Participant has suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months
Participant has a history of uncontrolled high blood pressure
Participant has clinical laboratory test results at entry that are outside the normal reference range
Participant is currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
Participant is a woman who is lactating or breast feeding
If a participant is a woman and could become pregnant during this study, she must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study
If a participant is post menopausal woman, she must be at least 45 years of age and have not menstruated for the last 12 months
If a participant is a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, she must have an additional blood test to see if you can participate
If the participant is male, he must agree to reduce the risk of female partner becoming pregnant during the study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bakersfield, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.New Haven, Connecticut
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Washington D.C., District of Columbia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Miami, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Miramar, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Newnan, Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Arlington Heights, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Skokie, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.West Dundee, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.South Bend, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Boston, Massachusetts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Ann Arbor, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 24, 2019. Always confirm current availability with the study team.

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