Protocol I1F-MC-RHAZ A Multicenter Study with a Randomized, Double-Blind,Placebo-Controlled Induction Dosing Period Followed bya Randomized Maintenance Dosing Period and a Long-Term Extension Period to Evaluate the Efficacy andSafety of LY2439821 in Patients with Moderate-to-Severe Plaque Psoriasis - UNCOVER-1
- Conditions
- Moderate to severe plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-002970-22-HU
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1296
•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
•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
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of Anti-IL-17 MAb in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks;Secondary Objective: • Efficacy of Anti-IL-17 MAb in subjects with moderate to severe chronic<br>plaque psoriasis based on sPGA and PASI over12 and 60 weeks<br><br>• Quality of life assessments based on patient reported outcomes over 12 and 60 weeks;Primary end point(s): Static Physician Global Assessment (sPGA) and Psoriasis Area and<br>Severity Index (PASI);Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •PASI and sPGA<br>•Quality of life assessments;Timepoint(s) of evaluation of this end point: At Week 12 and Week 60