NCT02826603

Trial name or title	Study of secukinumab compared to ustekinumab in subjects with plaque psoriasis (CLARITY)
Methods	RCT, active‐controlled, double‐blind study Date of study: July 2016 ‐ Location: worldwide Phase 3
Participants	Randomised: 1100 participants Inclusion criteria Must give a written, signed and dated informed consent Chronic plaque‐type psoriasis present for ≥ 6 months before randomisation Moderate‐severe plaque psoriasis as defined at randomisation by: PASI score of ≥ 12 and Body Surface Area (BSA) affected by plaque‐type psoriasis ≥10% and IGA mod 2011 ≥3 (based on a scale of 0‐4) Candidate for systemic therapy, defined as having psoriasis inadequately controlled by: topical treatment (including topical corticosteroids) or phototherapy, or previous systemic therapy, or both Exclusion criteria Forms of psoriasis other than plaque psoriasis Drug‐induced psoriasis Ongoing use of prohibited treatments Previous exposure to secukinumab or any other biologic drug directly targeting IL‐17A or IL‐17RA, or ustekinumab, or any therapies targeting IL‐12 or IL‐23 Use of any other investigational drugs within 5 half‐lives of the investigational treatment before study drug initiation Pregnant or nursing (lactating) women
Interventions	Intervention Secukinumab 300 (300 mg, SC at randomization, weeks 1, 2 and 3 and thereafter 4‐weekly till week 48) Control intervention Ustekinumab 45/90 (45 mg or 90 mg SC based on participant's weight (at randomization visit) to be administered at randomization, week 4, 16, 28 and 40)
Outcomes	At week 12 Primary composite outcome IGA 0/1 PASI 90 Secondary outcomes PASI 75 at week 12 and 52 PASI 90 at week 52 AEs
Starting date	Study start date: June 2016 Study completion date: August 2018
Contact information	Novartis Pharmaceuticals, 1‐888‐669‐6682, +41613241111
Notes	Ongoing study