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

• Status: Completed
• Trial end date: 2017-11-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.