Efficacy and Safety Study of SUNPG1622

NCT02980705 ↗

Phase 2 Terminated 180 enrolled Sun Pharmaceutical Industries, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.

Timeline

Start: 2017-11-06
Primary completion: 2019-02-21
Completion: 2019-09-03

Outcome

Missed primary endpoint

Stopped: “Study terminated-Sponsor's decision”

paper treatment difference, -6.31%; 95% confidence interval, -22.34 to 9.71; p = 0.44). PMID 37162744 ↗

paper Tildrakizumab treatment was generally well tolerated but did not improve ASAS20 response rate versus placebo in patients with AS. PMID 37162744 ↗

Publications

Peters E, Chou RC, Rozzo SJ, Yao SL, Fructuoso FJG. A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. J Clin Rheumatol. 2023 Aug 1;29(5):223-229. doi: 10.1097/RHU.0000000000001973. Epub 2023 May 10.

Drugs

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