subjects with moderate to severe chronic plaque-
Conditions
Interventions
Secukinumab 300 mg,Placebo,Secukinumab 150 mg
Active Comparator Biological/Vaccine,Placebo Comparator Other,Active Comparator Biological/Vaccine
Sponsors
Novartis (Thailand) Ltd
Novartis (Thailand) Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
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 study consent according to local laws and regulations. 2. Men and women at least 18 years of age at the time of screening. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline. 4. Moderate to severe psoriasis as defined at Baseline by:  PASI score of 12 or greater, and  IGA mod 2011 score of 3 or greater (based on a scale of 0 – 4), and  Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater. 5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:  topical treatment, and/or  phototherapy, and/or previous systemic therapy.
Exclusion criteria
Exclusion criteria: 1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline. 2. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at Baseline. 3. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to (Table 5-1). Subjects not willing to limit UV light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited. 4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations 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. 7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception during the entire study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU).. Effective contraception methods include: ï‚· Total abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence, (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. ï‚· Female sterilization: have had a surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking the study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. ï‚· Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject. ï‚· Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. ï‚· Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure < 1%), e.g., hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception, women should have been stable on the same pill for a minimum of 12 weeks before taking study treatment. NOTE: Women are considered post-menopausal and not of child-bearing potential if they have had: ï‚· 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile(e.g., age appropriate, history of vasomotor symptoms), or ï‚· Surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In case of oophorectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI 75 12 weeks PASI score,IGA mod 2011 12 weeks 0 or 1 response | — |
Secondary
| Measure | Time frame |
|---|---|
| PASI 90 12 weeks PASI score,PASI 75 52 weeks PASI score,IGA mod 2011 52 weeks 0 or 1 response,PASI 50/75/90/100 12 weeks and 52 weeks PASI score,Safety and tolerability 52 weeks vital signs, Clinical laboratory variables, ECG, Adverse events,ACR 20/50/70 52 weeks ACR20 Response Criteria | — |
Contacts
Public ContactKerstin Letzelter
Novartis Pharma AG
Outcome results
None listed