Efficacy and Safety Study of SUNPG1623

Summary

This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623

Timeline

Start

2017-04-19

Primary completion

2019-03-01

Completion

2019-09-24

Outcome

Met primary endpoint

paper At W24, 71.4%-79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p<0.01). PMID 33985942 ↗

registry analysis (superiority test); SUNPG1623 I vs Placebo; p = 0.0001; Cochran-Mantel-Haenszel NCT02980692 ↗

registry analysis (superiority test); SUNPG1623 II vs Placebo; p = 0.0006; Cochran-Mantel-Haenszel NCT02980692 ↗

registry analysis (superiority test); SUNPG1623 Dose III vs Placebo; p = 0.0088; Cochran-Mantel-Haenszel NCT02980692 ↗

registry analysis (superiority test); SUNPG1623 Dose IV vs Placebo; p = 0.0041; Cochran-Mantel-Haenszel NCT02980692 ↗

release “First Trial of ILUMYA™ in Patients with Psoriatic Arthritis Met Primary Efficacy Endpoint” sunpharma.com ↗

Publications

• Mease PJ, Chohan S, Fructuoso FJG, Luggen ME, Rahman P, Raychaudhuri SP, Chou RC, Mendelsohn AM, Rozzo SJ, Gottlieb A. Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study. Ann Rheum Dis. 2021 Sep;80(9):1147-1157. doi: 10.1136/annrheumdis-2020-219014. Epub 2021 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tildrakizumab	Monoclonal antibody	20 mg	Other
Subject	Tildrakizumab	Monoclonal antibody	100 mg	Other
Subject	Tildrakizumab	Monoclonal antibody	200 mg	Other

Indications