moderate to severe psoriasis MedDRA version: 18.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
NOVARTIS PHARMA S.A.S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged = 18 years old at the Screening visit. 2. Patients with a history of chronic moderate to severe plaque psoriasis (PASI = 12, BSA = 10 and IGA mod 2011 = 3) for at least 6 months. 3. Patients eligible for treatment with a biotherapy i.e. not adequately controlled with at least two conventional systemic therapies (including methotrexate, cyclosporine, phototherapy). 4. Patients able to understand and communicate with the investigator and comply with the requirements of the study (including administration of s.c. injections at home), capable of and willing to complete several questionnaires at visits, and must provide written, signed and dated informed consent before any study related activity is performed. 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 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to the study drug or to drugs of a similar chemical class. 2. Patients with recent (previous 6 months) or planned vaccination with live virus. 3. Patient participation in another clinical study during the 4 weeks prior to study drug initiation or 5 half-lives (whichever is the longest). 4. Patients taking other drugs for psoriasis (e.g. corticosteroids, vitamin D analogs, pimecrolimus, retinoids, salicylvaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, a-hydroxy or fruit acids). 5. Patients suffering from a skin condition other than moderate to severe plaque psoriasis that may confound psoriasis evaluation, or other inflammatory disease. 6. Patients suffering from drug-induced psoriasis (e.g. new onset or current exacerbation by beta-blockers, calcium channel inhibitors, or lithium), as judged by investigator. 7. Patients with underlying condition(s) (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiovascular (eg: heart failure NYHA class III or IV, unstable angina….), infectious, gastrointestinal or psychiatric) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy). 8. Patients with previous treatment with any agent targeting Interleukin (IL)-17 directly or IL-17 receptor (e.g. secukinumab, ixekizumab, or brodalumab). 9. Patients refusing to limit sunlight or Ultraviolet (UV) light exposure. 10. Patients unwilling to be subjected to repeated s.c. injections and venipuncture. 11. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (TB) infection as defined by a positive or indeterminate QuantiFERON TB Gold test (QFT) at screening visit. Patients with a positive QFT test may participate in the study if a full tuberculosis work up (according to local practice/guidelines) completed at least 12 weeks prior to study drug initiation establishes conclusively that the patient has no evidence of active tuberculosis. If the presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to guidelines for at least 4 weeks prior to study drug initiation. 12. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for skin Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non invasive malignant colon polyps that have been removed). 13. 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). 14. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment. 15. Active systemic infections during the 2 weeks prior to study drug initiation (exception: common cold) or any infection that reoccurs on a regular basis; investigator discretion should be used regarding patients who have traveled or resided in areas of endemic mycoses, such as histoplasmosis, coccidioidomycosis
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ To evaluate the change from baseline of PASI 2/ To evaluate correlation between PASI and proSPI(s);Timepoint(s) of evaluation of this end point: Week 16 and over time till Week 56 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI (Simplified Psoriasis Index). This index comprises 3 components: severity (s), psychosocial (p) and intervention, (i) evaluated by both the physician (proSPI) and the patient (self assessed: saSPI). Only the severity (s) component will be evaluated for the primary objective (both proSPI (s) and saSPI (s)). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis will be analyzed. ;Secondary Objective: • To assess PASI (weekly from week 0 to 4 then every 4 to 8 weeks until Week 56). • To evaluate correlation between PASI and proSPI (s). • To assess each component of proSPI (s, p and i) over time (weekly from Week 0 to 4 then every 4 to 8weeks until Week 56). • To assess each component of saSPI (s, p and i) over time (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56). • To assess DLQI over time (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56). • To assess self-administered PASI (SA-PASI) (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56). • To assess pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time (weekly from Week 0 to 4 then every 4 to 8 weeks until Week 56). • To evaluate correlation between proSPI (for each component: s, p and i) and DLQI • To evaluate correlation between proSPI (for components p and i) and PASI • To evaluate safety. ;Primary end point(s): To evaluate the change from baseline of proSPI (s) and saSPI (s) ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Countries
France
Contacts
Public ContactInformation&Communication Médicales
NOVARTIS PHARMA S.A.S
Outcome results
None listed