Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: LY3074828
Pharmaceutical Form: Lyophilisate for solution for injection
Other descriptive name: LY3074828
Concentration unit: mg milligram(
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Present with chronic plaque psoriasis, 1) plaque psoriasis involving =10% body surface area and absolute PASI score =12 in affected skin 2) sPGA score of =3 3) are willing and able to undergo punch biopsies • are =18 and = 75 years of age • have an adequate organ function are =18 and = 75 years of age 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study • Have presence or history within 12 months prior to screening of significant uncontrolled cerebrocardiovascular, presence of respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data • use of known drugs of abuse or known alcohol abuse • has Columbia Suicide Severity Rating Scale (C-SSRS) ideation within 1 month prior to screening or any suicidal behavior within 3 months prior to screening and either ideation or suicidal behavior during screening • evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies • have hepatitis C or test positive hepatitis C virus at screening • have hepatitis B or test positive for hepatitis B virus (HBV) at screening • are women who are breastfeeding or plan to during study • have donated blood of >500 mL within 14 days prior to baseline • have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening • have received a systemic (including oral) anti-infective agent for an infection within 28 days of screening • have evidence of active or latent tuberculosis (TB) • have received live vaccine(s) within 1 month of screening or intend to during the study • have significant allergies to humanized monoclonal antibodies or any components of the LY3074828 product formulation • have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years and cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization (Visit 2) • have any other skin conditions (excluding psoriasis) that would affect interpretation of the results • have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to randomization (Visit 2) • have received topical psoriasis treatment anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus, emollients and other nonprescription topical products containing urea, >3% salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos within 14 days prior to randomization (Visit 2) • have received anti-tumor necrosis factor (TNF) biologics or anti-IL-17 targeting biologics within 8 weeks prior to randomization (Visit 2) • have previous exposure to any biologic therapy targeting IL-23 either licensed or investigational • are unable or unwilling to avoid excessive sun
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that treatment with LY3074828 is superior to placebo in inducing PASI 90 response at Week 16 in subjects with moderate to severe plaque psoriasis;Primary end point(s): The proportion of subjects achieving PASI 90 ;Timepoint(s) of evaluation of this end point: after 16 weeks; Secondary Objective: To evaluate the safety and tolerability of treatment with LY3074828 To evaluate the efficacy of treatment with LY3074828 compared to placebo in inducing PASI 100 and PASI 75 at week 16 To evaluate the efficacy of treatment with LY3074828 compared to placebo in inducing sPGA 0 (clear) and sPGA 0/1 at week 16 To evaluate the effect of LY3074828 on patient reported outcome measures: Psoriasis Symptom Scale, Patient Global Assessment, DLQI, and SF-36 at Week 16 To characterize the long term efficacy of LY3074828 on the PASI 100, PASI 90 and PASI 75 responses at Week 52, 104 and 120 To characterize the long term efficacy of LY3074828 on patient reported outcome measures Psoriasis Symptom Scale, Patient Global Assessment, DLQI, and SF-36 at Weeks 52, 104, and 120 To characterize the PK of LY3074828 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of subjects achieving PASI 100 and PASI 75 The proportion of subjects achieving sPGA 0 and sPGA 0/1 The mean change from baseline for PSS, PatGA, DLQI, and SF-36 The proportion of subjects achieving PASI 100, PASI 90, and PASI 75 The mean change from baseline for PSS, PatGA, DLQI, and SF-36 Clearance and volume of distribution Adverse event and discontinuation rates ; Timepoint(s) of evaluation of this end point: The first 3 are at 16 weeks The next 2 are for Weeks 52, 104, and 120 | — |
Countries
Canada, Germany, Japan, Poland, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed