A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)

Summary

This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.

Timeline

Start

2010-10-25

Primary completion

2011-11-04

Completion

2012-10-24

Outcome

Met primary endpoint

registry analysis (superiority or other test); Part 1: Tildrakizumab 200 mg vs Part 1: Placebo; p <0.001; % Difference in Response Rate 69.97 (95% CI 58.96 to 80.99); Cochran-Mantel-Haenszel NCT01225731 ↗

paper At week 16, PASI 75 responses were 33·3% (n = 14), 64·4% (n = 58), 66·3% (n = 59), 74·4% (n = 64) and 4·4% (n = 2) PMID 26042589 ↗

Publications

• Results Papp K, Thaci D, Reich K, Riedl E, Langley RG, Krueger JG, Gottlieb AB, Nakagawa H, Bowman EP, Mehta A, Li Q, Zhou Y, Shames R. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015 Oct;173(4):930-9. doi: 10.1111/bjd.13932. Epub 2015 Oct 15.
• Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25.
• Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tildrakizumab	Monoclonal antibody	5 mg	Subcutaneous
Subject	Tildrakizumab	Monoclonal antibody	25 mg	Subcutaneous
Subject	Tildrakizumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Tildrakizumab	Monoclonal antibody	200 mg	Subcutaneous

Indications