A Study in Participants With Moderate to Severe Psoriasis

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ixekizumab

Criteria

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.