A Phase 3 Study in Moderate to Severe Psoriasis Patients

Phase 1

• Conditions: Moderate to severe chronic plaque psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-002970-22-DK
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-30
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1296

Inclusion Criteria

•Have active plaque psoriasis covering at least 10% body surface area and a PASI score of 12
•Candidate for phototherapy and/or systemic therapy
•Have a sPGA score of at least 3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

Exclusion Criteria

•Have pustular, erythrodermic, and/or guttate forms of psoriasis
•Have a history of drug-induced psoriasis
•Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline
•Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; ustekinumab <8 months; rituximab or efalizumab <12 months; or any other biologic agent <5 half-lives prior to baseline
•Have 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)
•Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study
•Have ever received natalizumab or other agents that target alpha-4-integrin
•Have participated in any study with IL-17 antagonist including LY2439821
•Have another serious disorder or illness
•Have suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months
•Have a history of uncontrolled high blood pressure
•Have clinical laboratory test results at entry that are outside the normal reference range
•Are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
•Are a woman who is lactating or breast feeding
•Are a woman and could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study
•Are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months
•Are a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate
•Are a male, you must agree to reduce the risk of your female partner becoming pregnant during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified