TCTR20161028001

Trial name or title	A randomised, double‐blind, placebo controlled, multicenter study of subcutaneous secukinumab, to demonstrate efficacy after twelve weeks of treatment and to assess safety, tolerability and long‐term efficacy up to one year in subjects with moderate to severe chronic plaque‐type psoriasis with or without psoriatic arthritis comorbidity
Methods	RCT, active/placebo‐controlled, double‐blind trial Date of study: February 2017 ‐ Location: Thailand
Participants	Randomised: 40 participants Inclusion criteria 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 Men and women ≥ 18 years of age at the time of screening Chronic plaque‐type psoriasis present for ≥ 6 months and diagnosed before baseline Moderate‐severe psoriasis Exclusion criteria Forms of psoriasis other than chronic plaque‐type (e.g. pustular, erythrodermic and guttate psoriasis) at screening or baseline Drug‐induced psoriasis (i.e. new onset or current exacerbation from beta‐blockers, calcium channel inhibitors or lithium) at baseline Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to (Table 5‐1). Paricipants 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 Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL‐17 or the IL‐17 receptor Use of other investigational drugs at the time of enrolment, or within 5 half‐lives of enrolment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations
Interventions	Intervention A. Secukinumab 300 mg SC (administration not specified) Control intervention B. Secukinumab 150 mg SC (administration not specified) C. Placebo
Outcomes	At week 12 Primary outcome (composite) IGA 0/1 PASI 75 Secondary outcomes ACR 20/50/70 (timeframe 12 weeks and 52 weeks) PASI 50/75/90/100 (timeframe 12 weeks and 52 weeks PASI score) Safety and tolerability
Starting date	28 February 2017
Contact information	Kerstin Letzelter, kerstin.letzelter@novartis.com
Notes	Ongoing study

BMI: body mass index; BSA: Body Surface Area; ECG: electrocardiogram; FAEs: fumaric acid esters; IV: intravenous; NAPSI: Nail Psoriasis Severity Index; PASI: Psoriasis Area and Severity Index; PGA: Physician's Global Assessment; QoL: quality of life; RCT: randomised controlled trial: SC: subcutaneous; sPGA: static physician global assessment; TB: tuberculosis; UVA/B: ultraviolet A/B