A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis

Summary

This is a phase Ⅲ, randomized, double-blind, placebo-controlled, parallel design, multicenter trial to evaluate the efficacy, safety, tolerability, and immunogenicity of subcutaneous Tildrakizumab in subjects with moderate to severe chronic plaque psoriasis. The trial was divided into two parts: the base study (Week 0- Week 12) and the extension study (Week 13- Week 54).

Timeline

Start

2020-12-17

Primary completion

2021-06-07

Completion

2022-07-08

Outcome

Met primary endpoint

paper PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) PMID 38192233 ↗

Publications

• Yu C, Geng S, Yang B, Deng Y, Li F, Kang X, Bi M, Zhang F, Zhao Y, Pan W, Tian Z, Xu J, Zhang Z, Yu N, Duan X, Guo S, Sun Q, Li W, Tao J, Liu Z, Yin Y, Wang G. Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension. Chin Med J (Engl). 2024 May 20;137(10):1190-1198. doi: 10.1097/CM9.0000000000002873. Epub 2024 Jan 9.

Drugs

Indications