chronic moderate to severe plaque type psoriasis MedDRA version: 17.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 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. 2. Men or women = 18 years of age at time of screening 3. Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score > 10 at baseline. 4. Psoriasis patients with pruritus intensity of = 30 on a 100-point VAS (the worst itching within a recall period of 24 hours as part of the Patients Global Assessment of Chronic Pruritus, PGA-CP), both, at screening and at baseline. 5. Inadequate response, intolerance or contraindication to phototherapy or conventional systemic psoriasis treatment as documented in the patient’s medical history or reported by the patient or determined by the investigator at screening. Relative contraindications such as interference of patient’s lifestyle with the treatment are accepted. 6. According to local guidelines and practice, the patient should be eligible for follow-on psoriasis treatment with biologics after the completion of the study. 7. At least one of the following to exclude chest infection and malignancy before initiation of a biologic immunomodulating therapy in accordance with current clinical guidelines: • Imaging of the chest (X-ray, CT, or MRI) obtained within 12 weeks prior to screening, and evaluated by a qualified physician. • MRI of the chest obtained and evaluated by a qualified physician during screening and prior to baseline. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes). 2. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start. 3. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) at study start. 4. Ongoing use of prohibited psoriasis and non-psoriasis treatments (see section 6.6.8). Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study. 5. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. 6. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A or the IL-17A Receptor (e.g. brodalumab, ixekizumab). 7. Women a) Who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy and subsequent positive hCG laboratory test). b) Who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 16 weeks after the end of treatment. A negative pregnancy test for all women is required with sufficient lead time before inclusion. 8. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. Patients with psoriatic arthritis are not excluded. 9. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy. 10. Subjects with a serum creatinine level exceeding 2.0 mg/dl (176.8 µmol/l) at screening. 11. Screening total white blood cell (WBC) count <2,500/µl, or platelets <100,000/µl or neutrophils <1,500/µl or hemoglobin <8.5 g/dl. 12. Imaging of the chest (X-ray, CT, or MRI) obtained within 12 weeks prior to screening, and evaluated by a qualified physician or MRI of the chest obtained and evaluated by a qualified physician during screening and prior to baseline with evidence of ongoing infectious or malignant process. 13. Active systemic infections during the last two weeks (exception: common cold) prior to baseline or any infection that reoccurs on a regular basis. 14. History of an ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test. Subjects with a positive or indeterminate QuantiFERON TB-Gold test may participate in the study if further full tuberculosis work up (according to local practice/guidelines) completed at least 12 weeks prior to baseline establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines for at least 4 weeks prior to baseline. 15. Past medical history record of infection with HIV, hepatitis B or hepatitis C prior to baseline. 16. His
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that secukinumab has superior efficacy compared to placebo on the pruritus intensity VAS (the worst itching within a recall period of 24 hours as part of the Patients Global Assessment of Chronic Pruritus, PGA-CP) measured at week 32 in patients with moderate to severe psoriasis.;Secondary Objective: no secondary objectives;Primary end point(s): The primary endpoint is the pruritus intensity VAS with a recall period of 24 hours (as part of the PGA-CP) measured in the FAS-R at week 32.;Timepoint(s) of evaluation of this end point: at week 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed