Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

Summary

The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily \[BID\] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).

Timeline

Start

2015-01-08

Primary completion

2017-09-25

Completion

2019-06-03

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs Apremilast 30 mg; p = 0.0142; Stratified Difference 19.2 (95% CI 3.4 to 33.6); Cochran-Mantel-Haenszel NCT02289417 ↗

registry analysis (superiority test); Placebo vs Apremilast 40 mg; p = 0.2689; Stratified Difference 7.7 (95% CI -6.9 to 22.0); Cochran-Mantel-Haenszel NCT02289417 ↗

Publications

• Danese S, Neurath MF, Kopon A, Zakko SF, Simmons TC, Fogel R, Siegel CA, Panaccione R, Zhan X, Usiskin K, Chitkara D. Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2526-2534.e9. doi: 10.1016/j.cgh.2019.12.032. Epub 2020 Jan 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	30 mg	Oral
Subject	Apremilast	Small molecule	40 mg	Oral

Indications