NCT03504852.

Study name	Efficacy and safety of 2 secukinumab regimens in 90 kg or higher subjects with moderate to severe chronic plaque‐type psoriasis
Methods	RCT, active‐controlled, double‐blind study Date of study: June 2018 Location: world‐wide Phase 3
Participants	Randomised: 331 participants Inclusion criteria Written informed consent must be obtained before any assessment is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations Participants must be able to understand and communicate with the investigator and comply with the requirements of the study Men or women at least 18 years of age at time of screening Body weight of ≥ 90 kg at the time of randomisation Chronic plaque‐type psoriasis present for at least 6 months and diagnosed before randomisation Moderate‐to‐severe psoriasis as defined at randomisation by: PASI score ≥ 12, and IGA mod 2011 score ≥ 3 (based on a static scale of 0 ‐ 4), and BSA affected by plaque‐type psoriasis ≥ 10% Candidate for systemic therapy. This is defined as a person 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 Forms of psoriasis other than chronic plaque‐type (e.g. pustular, erythrodermic and guttate psoriasis) at screening or randomisation Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. People 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 randomisation or during the study period is also prohibited Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin‐17 (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 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations Pregnant or nursing (lactating) women History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (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) History of hypersensitivity to any of the study drug constituents
Interventions	Intervention A. Secukinumab 300 mg every 2 weeks Control interventions B. Secukinumab 300 mg every 4 weeks
Outcomes	At week 16 Primary outcome PASI 90 Secondary outcome IGA 0/1
Starting date	Study start date: June 2018 Estimated study completion date: July 2020 Last update posted: July 2020, active, not recruiting
Contact information	Study Director: Novartis Pharmaceuticals
Notes	Ongoing study Last checked in September 2020