Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients

Summary

This is a Phase IIa (proof of concept), randomized, double blind, placebo-controlled, multicentre clinical trial to evaluate the safety and efficacy of daily PBF-677 oral treatment during 28 days in Ulcerative colitis (UC) patients who are not receiving immunosuppressants and present mild-to-moderate activity of the disease. Enrolled patients would receive standard high doses of 5-ASA (4g), according to current clinical guidelines, and are randomized to receive also PBF-677 or placebo.

Timeline

Start

2018-07-01

Primary completion

2021-05-27

Completion

2021-05-27

Drugs

Indications