A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

A 24-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients With Moderate-to-Severe Plaque Psoriasis Who Are Naive to Systemic Treatment With an Extension Period

The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.

Inclusion Criteria:

• Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline.
• Participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis.
• Have a (PASI score >10 or BSA >10) and DLQI >10 at screening and at baseline.

Exclusion Criteria:

• Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
• Have received systemic nonbiologic psoriasis therapy.
• Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy.
• Have any condition or contraindication as addressed in the local labeling for MTX or FAE.
• Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening.
• Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer.
• Have had a serious infection or are immunocompromised.
• At screening, participants with significant, present, or early liver disease, e.g., explained by alcohol consumption or hepatic insufficiency.