Plaque Psoriasis MedDRA version: 19.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Cosentyx
Product Name: secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy. 2. Moderate to severe psoriasis at Baseline as evidenced by: • PASI = 10 and • IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and • BSA affected by plaque-type psoriasis of = 10%. Other protocol-defined inclusion criteria may apply 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 1422 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 158
Exclusion criteria
Exclusion criteria: 1. History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti-interleukin (IL)12/23, or any anti-IL-17A or IL-17A receptor (IL 17AR) antibody. 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes including latex hypersensitivity. 3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis). 4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium). 5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy). 6. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug. 7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL). 8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during entire study or longer if required by locally approved prescribing information (e.g. in EU 20 weeks). 9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. 10. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Psoriasis Area and Severity Index 90 response rate;Timepoint(s) of evaluation of this end point: 52 weeks; Secondary Objective: To demonstrate in the patient pool of PASI 75 responders who do not reach a PASI 90 response at Week 24 that secukinumab 300 mg s.c. administered at a shorter dosing interval is superior to secukinumab 300 mg s.c. administered every 4 weeks at Week 52 based on the PASI 90 response rate. Evaluate the proportion of PASI 50, PASI 75, PASI 100 and Novartis Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1 responder rates at Week 52. Evaluate the course of mean PASI over time from Week 24 to Week 52. Evaluate the effect of different maintenance treatment frequencies on patient reported outcomes (PROs): Dermatology Life Quality Index (DLQI©), EuroQOL 5-Dimension Health Questionnaire (EQ-5D©), Work Productivity and Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), and the patient’s assessment of pain, itching and scaling. ;Main Objective: To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Psoriasis Area and Severity Index 90 response rate 2) Psoriasis Area and Severity Index 50 response rate 3) Psoriasis Area and Severity Index 75 response rate 4) Psoriasis Area and Severity Index 100 response rate 5) Investigator's Global Assessment modified 2011 0/1 responder rates 6) mean Psoriasis Area and Severity Index 7) Dermatology Life Quality Index (DLQI©) 8) EuroQOL 5-Dimension Health Questionnaire (EQ-5D©) 9) Work Productivity and Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) 10) patient’s assessment of pain, itching and scaling. ; Timepoint(s) of evaluation of this end point: 1) week 52 2) week 52 3) week 52 4) week 52 5) week 52 6) From week 24 to Week 52 7) week 52 8) week 52 9) week 52 10) week 52 | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Novartis Farma - Produtos Farmacêuticos, S.A.
Outcome results
None listed