Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

Summary

The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).

Timeline

Start

2016-12

Primary completion

2018-03-26

Completion

2018-03-26

Outcome

Missed primary endpoint

Stopped: “Data Monitoring Committee discontinued the trial due to futility-based outcome”

paper Although this phase 2a study initially did not meet the primary endpoint PMID 34474038 ↗

Publications

• Sandborn WJ, Mattheakis LC, Modi NB, Pugatch D, Bressler B, Lee S, Bhandari R, Kanwar B, Shames R, D'Haens G, Schreiber S, Danese S, Feagan B, Pai RK, Liu DY, Gupta S. PTG-100, an Oral alpha4beta7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis. Gastroenterology. 2021 Dec;161(6):1853-1864.e10. doi: 10.1053/j.gastro.2021.08.045. Epub 2021 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PTG-100	Peptide	150 mg	Oral
Subject	PTG-100	Peptide	300 mg	Oral
Subject	PTG-100	Peptide	900 mg	Oral

Indications