NCT04488185.

Methods	RCT, placebo‐controlled, double‐blind study Date of study: June 2020 Location: unknown
Participants	Inclusion criteria: Clinical diagnosis of chronic plaque‐type psoriasis confirmed through physical examination by a dermatologist, with at least 6 months of clinical history prior to the baseline visit Moderate‐to‐severe plaque psoriasis at baseline, defined as: ≥ 10 % Body Surface Area (BSA) involvement, or ≥ 3% to < 10% BSA with involvement of special regions (nails, scalp, or intertriginous skin), or with a history of psoriatic arthritis in a parent Candidate for systemic therapy, defined as having psoriasis inadequately controlled by current topical and/or systemic treatment(s) (including topical corticosteroids), phototherapy, or previous systemic therapies Presence of sonographic enthesitis at screening, in at least 1 enthesis, defined by the presence of at least abnormal thickening and hypoechogenicity of the tendon insertion, with or without presence of Doppler signal (Grade 0 ‐ 3), or by the presence of grade ≥ 2 Doppler signal, independent of gray scale abnormalities Exclusion criteria: Diagnosis of PsA as per CASPAR confirmed by a rheumatologist (including the presence of inflammatory pain in entheses or joints), and any other known rheumatological disease affecting the assessed joints Exposure to any IL‐17 or IL‐23(p19) inhibitor for the treatment of psoriasis (approved or investigational) within 12 months prior to screening, or exposure to any inhibitors of TNF‐ɑ and IL12/23 within 6 months prior to screening Previous exposure to non‐biologic systemic therapy for psoriasis, including methotrexate, PDE‐4 inhibitors, or systemic corticosteroids within 12 weeks or 5 half‐lives (whichever is longer) prior to screening A degree of obesity that impedes proper ultrasound examination of entheses and joints Forms of diagnosed psoriasis other than chronic plaque psoriasis (e.g. erythrodermic, generalised or localised pustular psoriasis, or new‐onset guttate psoriasis) Other protocol‐defined inclusion/exclusion criteria may apply
Interventions	Intervention A. Secukinumab 300 mg administered SC (2 single‐use prefilled syringes of 150 mg/mL), on Days 1, 8, 15, 22, 29, 57, 85. Control intervention B. Placebo
Outcomes	At week 16 Primary outcome Change from baseline in the Outcome Measures in Rheumatology (OMERACT) ultrasound enthesitis score Secondary outcome Change from baseline in the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) ultrasound enthesitis score Change from baseline in the PsASon13 unilateral ultrasound composite score of synovitis Number of participants who achieve complete resolution of enthesitis based on OMERACT criteria Number of participants who achieve Psoriasis Area and Severity Index 90 (PASI 90) Number of participants who achieve Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 Change from baseline in Dermatology Life Quality Index (DLQI) score
Notes	Waiting for subgroup analyses for participants with moderate‐to‐severe psoriasis

AEs: adverse effects; BMI: body mass index; BSA: body surface area;DLQI: Dermatology Life Quality Index; ECG: electrocardiogram; eow: every other week; FAEs: fumaric acid esters; IGA: Investigator's Global Assessment; IM: intramuscular; IV: intravenous; NAPSI: Nail Psoriasis Severity Index; PASI: Psoriasis Area and Severity Index; PGA: Physician's Global Assessment; PUVA: psoralen plus ultraviolet A; RCT: randomised controlled trial; SC: subcutaneous; SF36: short‐form 36; SPGA: static physician global assessment; TB: tuberculosis; UVB: ultraviolet B; VAS: visual analogue scale
Please note that the term “conventional” in these tables is replaced with “non‐biological treatment” in the main text of this review.