Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Summary

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

Timeline

Start

2016-06-22

Primary completion

2018-07-09

Completion

2018-07-09

Outcome

Met primary endpoint

registry Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg; p <0.0001; Odds Ratio (OR) 2.21 NCT02826603 ↗

registry Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg; p <0.0001; Odds Ratio (OR) 2.10 NCT02826603 ↗

paper Both co-primary objectives were met: secukinumab was superior to ustekinumab PMID 30334147 ↗

release “CLARITY study show Cosentyx ® (secukinumab) was significantly more effective than Stelara ®* (ustekinumab) in delivering clear and almost clear skin at 12 weeks” novartis.com ↗

release “achieved both co-primary endpoints PASI 90 and IGA mod 2011 0/1” novartis.com ↗

release “CLARITY study met all primary and secondary endpoints” novartis.com ↗

Publications

• Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.
• Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.
• Bagel J, Blauvelt A, Nia J, Hashim P, Patekar M, de Vera A, Ahmad K, Paguet B, Xia S, Muscianisi E, Lebwohl M. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY). J Eur Acad Dermatol Venereol. 2021 Jan;35(1):135-142. doi: 10.1111/jdv.16558. Epub 2020 Jun 8.
• Bagel J, Nia J, Hashim PW, Patekar M, de Vera A, Hugot S, Sheng K, Xia S, Gilloteau I, Muscianisi E, Blauvelt A, Lebwohl M. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther (Heidelb). 2018 Dec;8(4):571-579. doi: 10.1007/s13555-018-0265-y. Epub 2018 Oct 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous
Comparator	Ustekinumab	Monoclonal antibody	45 mg	Subcutaneous
Comparator	Ustekinumab	Monoclonal antibody	90 mg	Subcutaneous

Indications