Moderate to severe active, chronic plaque psoriasis MedDRA version: 17.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Novartis Pharmaceuticals UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening - Moderate to severe disease severity at randomisation •PASI =10 and •DLQI >10 - Failed to respond to systemic therapies including ciclosporin, methotrexate and PUVA/Phototherapy (or is intolerant and/or has a contraindication to these) - Previously treated with at least one anti-TNFa for moderate or severe psoriasis but is a primary or secondary non-responder. 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 258 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) - Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) - Use of prohibited psoriasis or non-psoriasis treatments - Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor - Pregnant or nursing (lactating) women - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment. - Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment. - Plans for administration of live vaccines during the study period or 6 weeks prior to initiation of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of secukinumab (300mg) treatment with respect to PASI 75 response rate after 16 weeks treatment, by assessing the percentage (%) of patients achieving PASI 75 after 16 weeks compared to baseline (defined as PASI status at Week 0).;Secondary Objective: 1.To evaluate the efficacy of secukinumab (150mg) treatment with respect to PASI 75 response rate after 16 weeks treatment, by assessing the percentage (%) of patients achieving PASI 75 after 16 weeks compared to baseline (defined as PASI status at Week 0). 2.To evaluate the efficacy of secukinumab treatment with respect to PASI 75 response rate after 16 weeks treatment compared to baseline in the 3 key patient subgroups for both •300mg secukinumab •150mg secukinumab 3.To evaluate the efficacy of secukinumab (300mg and 150mg secukinumab) treatment with respect to PASI response rate compared to baseline: •% of patients achieving PASI 90 after 16 wks •% of patients achieving PASI 75 after 2, 4, 8, 12, 24, 48 and 72 wks To evaluate the efficacy of secukinumab (300mg and 150mg secukinumab) treatment compared to baseline wrt: •% of patients achieving PASI 50 after 2, 4, 8, 16, 12, 24, 48 and 72 wks •% of patients achieving PASI 90 after 2, 4, 8, 12, 24, 48 and 72 wks ;Primary end point(s): The primary outcome variable is the PASI 75 response at 16 weeks: subjects achieving = 75% improvement (reduction) in PASI score compared to baseline are defined as PASI 75 responders;Timepoint(s) of evaluation of this end point: 16 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following key secondary variables will be analysed for 300mg and 150mg secukinumab by the same method as the primary variable. •Percentage of patients achieving PASI 90 after 16 weeks •Percentage of patients achieving PASI 75 after 2 weeks •Percentage of patients achieving PASI 75 after 4 weeks •Percentage of patients achieving PASI 75 after 8 weeks •Percentage of patients achieving PASI 75 after 12 weeks •Percentage of patients achieving PASI 75 after 24 weeks •Percentage of patients achieving PASI 75 after 48 weeks •Percentage of patients achieving PASI 75 after 72 weeks PASI 50, PASI 75, PASI 90 response over time (2 - 72 weeks);Timepoint(s) of evaluation of this end point: The following key secondary variables will be analysed for 300mg and 150mg secukinumab by the same method as the primary variable. •Percentage of patients achieving PASI 90 after 16 weeks •Percentage of patients achieving PASI 75 after 2 weeks •Percentage of patients achieving PASI 75 after 4 weeks •Percentage of patients achieving PASI 75 after 8 weeks •Percentage of patients achieving PASI 75 after 12 weeks •Percentage of patients achieving PASI 75 after 24 weeks •Percentage of patients achieving PASI 75 after 48 weeks •Percentage of patients achieving PASI 75 after 72 weeks PASI 50, PASI 75, PASI 90 response over time (2 - 72 weeks) | — |
Countries
Ireland, United Kingdom
Contacts
Public ContactJudy Thuo
Novartis Pharmaceuticals UK Limited
Outcome results
None listed