Plaque Psoriasis psoriasis vulgaris
Conditions
Interventions
Investigational Product, Dosage, and Mode of Administration or Intervention:
Induction Dosing Period
* 80 mg LY2439821 Q2W = A starting dose of 160 mg (Week 0) given as 2
subcutaneous (SC) injection
80 mg given as 1 SC injection Q4W
thereafter.
* 80 mg LY2439821 Q12W = A dose of 80 mg given as 1 SC injection + placebo for
LY2439821 as 1 SC injection at Week 12
80 mg given as 1 SC injection Q12W
thereafter. To maintain blinding with Q4W dose regimen, placebo will given as
1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, 56, and so on, until the
study i
Induction Dosing Period: 12
Weeks
Maintenance Dosing Period: 48 weeks
Long-Term Extension Period: 196
weeks
Post-Treatment Follow-Up Period: 12 to 24 weeks after the date of the
patient*s ETV or last regularly scheduled visit).
Reference Therapy, Dose, and Mode of Administra
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization ;-At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization ;-Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization ;-Candidate for phototherapy and/or systemic therapy ;-Men must agree to use a reliable method of birth control during the study ;-Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion criteria
Exclusion criteria: -Pustular, erythrodermic, and/or guttate forms of psoriasis ;-History of drug-induced psoriasis ;-Prior use of etanercept ;-Clinically significant flare of psoriasis during the 12 weeks prior to randomization;-Concurrent or recent use of any biologic agent;-Received non-biologic systemic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization;-Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization;-Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study ;-Have participated in any study with IL-17 antagonists, including LY2439821;-Serious disorder or illness other than plaque psoriasis ;-Serious infection within the last 3 months ;-Breastfeeding or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Criteria for Evaluation: Efficacy: The primary efficacy endpoints are sPGA (0,1) and PASI 75 response at Week 12 (Visit 7). The following secondary efficacy endpoints will be assessed in this study: PASI 50, PASI 90, PASI 100, NAPSI, PSSI, PPASI 50, PPASI 75, PPASI 100 and percent of BSA involvement of Ps. Health Outcomes: The following health outcome measures will be assessed in this study: Itch NRS, DLQI, QIDS SR16, WPAI-PSO, SF-36, patient*s global assessment of disease severity, Joint Pain VAS, EQ-5D 5L, Skin Pain VAS, healthcare resource utilization, PSAB, and ENSEMBLE MDS. Safety: The following safety measures will be assessed in this study: serious adverse events (SAEs), adverse events (AEs), AEs of special interest (AESI), concomitant medications, physical evaluations, chest x-ray and tuberculosis (TB) testing, vital signs, electrocardiograms (ECGs), blood pressure, and laboratory evaluations (including immunogenicity testing [anti-drug antibodies (ADAs)] and safety-related immune markers such as neutrophil counts). Immunogenicity: Immunogenicity will be assessed by a validated assay designed to perform in the presence of LY2439821. Bioanalytical: Concentrations of immunoreactive LY2439821 in human serum will be determined by a validated method. Translational Medicine: A blood sample will be collected for pharmacogenetic analyses. Serum, plasma, and whole blood ribonucleic acid (RNA) samples will be collected for potential nonpharmacogenetic biomarker research where local regulations allow. Samples may be used for research on IL-17, disease process, pathways associated with Ps, mechanism of action of LY2439821, response to treatment with LY2439821, and/or research methods or in validating diagnostic tools or assay(s) related to Ps | — |
Secondary
| Measure | Time frame |
|---|---|
| See primary parameters/outcome for all outcomes. | — |
Countries
Netherlands
Outcome results
None listed