chronic moderate to severe plaque type psoriasis MedDRA version: 18.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Secukinumab auto-injector
Product Code: AIN457
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Other descriptive name: SECUKINUMAB
C
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be able to understand and communicate with the investigator and must give a written, signed and dated informed consent before any study related activity is performed and who are willing and capable to comply with all study procedures. 2. Men or women at least 18 years of age at time of screening. 3. Chronic plaque type psoriasis diagnosed for at least 6 months prior to baseline 4. Moderate to severe plaque type psoriasis at baseline derived from the European consensus (Mrowietz et al., 2011): • BSA (Body Surface Area) >10% and PASI>10 and • DLQI>10. 5. Candidates for biologic therapy who failed to respond to, or who had a contraindication to or were intolerant to at least one previous conventional systemic therapy. 6. According to local guidelines, to exclude chest infection before initiation of a biologic immunomodulating therapy, it is necessary to have obtained an image of the chest (X-ray or magnetic resonance imaging) within 12 weeks prior to screening and have this evaluated by a qualified physician. 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: 1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic or guttata psoriasis). 2. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium). 3. Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. 4. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of 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. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures. 8. Study personnel or first degree relatives of investigator(s) must not be included in the study. 9. Women • 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 hCG laboratory test (> 5 mIU/ml)) • 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 20 weeks after the end of treatment, unless total abstinence (when this is in line with the preferred and usual lifestyle of the subject) is practiced. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion 10. 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. 11. 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. 12. Subjects with preexisting or recent-onset central or peripheral nervous system demyelinating disorders at discretion of the investigator. 13. Significant medical problems, including but not limited to congestive heart failure [New York Heart Association status of class III or IV]. 14. Subjects with a serum creatinine level exceeding 2.0 mg/dl (176.8µmol/l) at screening. 15. 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. 16. Active systemic infections during the last two weeks (exception: common cold) prior to screening or any infection that reoccurs on a regular basis. 17. History of an ongoing, chronic or recurrent infectious disease including recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test at screening. 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 first study drug administration 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 mai
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that 300 mg secukinumab administered every 2 weeks is superior in achieving PASI 90 at week 32 compared to 300 mg secukinumab every 4 weeks in patients who after treatment with the standard dose had less than almost clear skin (PASI=75 to PASI<90) at week 16.;Secondary Objective: To evaluate PASI 50, 75, 90 and 100 response over time (PASI 50 and 75 response only until week 16). To evaluate the change of mean PASI score (points) over time. To evaluate DLQI over time. To evaluate IGA (Investigator Global Assessment) 5-point scale mod. 2011 over time. To investigate the clinical safety and tolerability of 300 mg secukinumab every 2 weeks as assessed by vital signs, clinical laboratory variables, ECGs, and adverse events monitoring in comparison to standard maintenance every 4 weeks. ;Primary end point(s): The primary endpoint is the proportion of patients achieving PASI 90 at week 32 in the shortened dosage interval arm and the standard treatment arm.;Timepoint(s) of evaluation of this end point: at week 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • proportion of patients achieving PASI 50, 75, 90, 100 at weeks 1, 2, 3, 4, 8, 12 and 16 • proportion of patients achieving PASI 90, 100 at weeks 18, 22, 26, 30 and 32 in the dose increase arm and the standard treatment arm • the mean PASI score (points) at all measurement times • proportion of patients achieving DLQI =5 or DLQI 0/1 at weeks 4 and 16 • proportion of patients achieving DLQI =5 or DLQI 0/1 at weeks 18, 22, 26, 30 and 32 in the dose increase arm and the standard treatment arm • proportion of patients achieving IGA 0 or 1 response at weeks 4 and 16 • proportion of patients achieving IGA 0 or 1 response at weeks 18, 22, 26, 30 and 32 in the dose increase arm and the standard treatment arm ;Timepoint(s) of evaluation of this end point: see field E.5.2 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed