Moderate to severe chronic plaque-type psoriasis MedDRA version: 18.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg mi
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations. 2) Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307 3) Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator 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 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1) A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject 2) Ongoing use of prohibited psoriasis or nonpsoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study. 3) Subjects expected to be exposed to an undue safety risk if participating in the trial 4) Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial 5) Plans for administration of live vaccines during the study period 6) 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 hCG laboratory test (>10 mIU/mL). Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the number and percentage of subjects having any AE ;Secondary Objective: 1) To evaluate change in PASI 75 responses 2) To evaluate Investigator Global Asessment (IGA) Response 3) To evaluate change in Quality of Life Response;Primary end point(s): The number and percentage of subjects having any AE, having an AE in each primary system organ class and having each individual AE;Timepoint(s) of evaluation of this end point: 104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in PASI 75 responses 2) Investigator Global Asessment (IGA) Response 3) Change in DLQI©, EQ-5D©, and HAQ©-DI responses.;Timepoint(s) of evaluation of this end point: 1) Week 92, Week 104, Week 144, Week 156 2) week 104 3) Baseline, week 104 | — |
Countries
Austria, Bulgaria, Canada, Czech Republic, France, Germany, India, Italy, Japan, Poland, Singapore, Slovakia, Switzerland, United Kingdom, United States, Vietnam
Contacts
Public ContactInformacní služba - klin. hodnocení
Novartis s.r.o.
Outcome results
None listed