A Study in Participants With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Ixekizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate; Severe; Plaque; Chronic

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.
    

Eligibility 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.