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

Lilly

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Fumaric Acid Esters; Drug: Methotrexate; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02634801

2015-002649-69 (EudraCT Number)

16190

I1F-EW-RHBZ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 3 patient groups

Ixekizumab

Experimental group

Description:

160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24. Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Treatment:

Drug: Ixekizumab

Fumaric Acid Esters

Active Comparator group

Description:

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Treatment:

Drug: Fumaric Acid Esters

Drug: Ixekizumab

Methotrexate

Active Comparator group

Description:

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Treatment:

Drug: Methotrexate

Drug: Ixekizumab