CompletedPhase 2NCT01107457

A Study in Participants With Moderate to Severe Psoriasis

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.

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

StatusCompleted
PhasePhase 2
U.S. locations34
SponsorEli Lilly and Company
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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 Exclusion Criteria Specific to B: * If a participant experienced a serious adverse event during Part A considered possibly related to ixekizumab * If a participant experienced an adverse event during Part A that the study doctor believes continued ixekizumab treatment could cause harm to the participant. Exclusion Criteria Specific to C: * If a participant experienced a Serious Adverse Event during Part B considered possibly related to ixekizumab * If a participant experienced an adverse event during Part B that the study doctor believes continued ixekizumab treatment could cause harm to the participant.

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

04
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.

View original record ↗