Patients With Moderate-To-Severe Psoriasis MedDRA version: 18.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Ixekizumab
CAS Number: 1143503-69-8
Current Sponsor code: LY2439821, ixeki
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Common to Both Part A and B: [1] Ambulatory male or female patients =18 years of age. [1a] Male patients: agree to use a reliable method of birth control during the study. [1b] Female patients: Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate (45 years of age who have had a cessation of menses for at least 12 months OR are women between 40 and 45 years of age who test negative for pregnancy, have had a cessation of menses for at least 12 months, and have a Follicle Stimulating Hormone (FSH) value >40 mIU/mL. [2] Present with chronic plaque psoriasis based on a diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization; at least 10% BSA involvement; and a PASI score of at least 12 at Visits 1 and 2 [30] Are a candidate for systemic therapy. [31] Have a sPGA score of at least 3 at Visits 1 and 2. Inclusion Criterion Specific to Part B: [32] Patients who have completed the treatment period for Part A. A patient is defined as having completed the treatment period for Part A if he/she has completed at least through Week 20. Inclusion Criterion Specific to Part C [35] Patients who have completed the treatment period for Part B. 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 3. Have pustular, erythrodermic and/or guttate forms of psoriasis. 4. Have had a clinically-significant flare of psoriasis during the 12 weeks prior to randomization. 5. 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 or therapeutic sunbathing) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization 6. Concurrent or recent use of any biologic agent within the following washout periods: etanercept 160 mm Hg or diastolic blood pressure >100 mm Hg. 19 Have current or a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years. 20 Have a history of atopy or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions 21 Have laboratory test values outside the reference range for the population or investigative site that are considered clini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that at least 1 LY2439821 treatment group is superior to placebo in the proportion of adult patients with moderate-to-severe chronic plaque psoriasis who achieve a 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index (PASI 75) and to estimate the percentage PASI improvement by treatment using regression techniques.;Secondary Objective: •To test the hypothesis that: - at least one LY2439821 treatment group is superior to placebo in the proportion of patients with a sPGA score of cleared (0) or minimal (1) with at least a 2 point improvement from baseline at W12 - LY2439821 is superior to placebo in the sPGA at W 12 and to measure the response by treatment group •To evaluate the proportion of patients who achieve: - sPGA score of cleared (0) or minimal (1) at W20 - 75% improvement from baseline in the PASI at W20 •To explore: - relationships between LY2439821 dose regimens and health outcomes - immunogenicity as measured by anti-LY2439821 antibody titers - relationships between clinical response and systemic exposure across the dose regimens •To evaluate: - safety and tolerability of LY2439821 - sustained efficacy in patients who experience treatment benefit at W20 - LY2439821 pharmacokinetics after multiple doses - effect of long term LY2439821 treatment on disease severity as measured by PASI & sPGA;Primary end point(s): primary end point a 75% improvement in PASI score (PASI 75).;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI). - Quality of life assessments based on patient reported outcomes over 12 and 20 weeks ;Timepoint(s) of evaluation of this end point: through Week 20 | — |
Countries
Denmark, United States
Contacts
Public ContactClinical trial information
Eli Lilly and Company
Outcome results
None listed