NCT03773952

Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients

A Phase IIa (Proof of Concept), Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Oral Treatment With PBF-677 in Patients With Mild to Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Palobiofarma SL · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Proof-of-concept clinical trial is carefully designed to establish the safety profile of PBF-677 over 28 days in mild to moderate ulcerative colitis population and explore the relationship between the 200 mg PBF-677 dose and induction of remission, according to clinical parameters (Partial Mayo Score) and a faecal surrogate biomarker of mucosal inflammation (Calprotectin). The trial also will explore the PBF-677 pharmacokinetics (PK) profile during 28 days of administration. This small-scale study has been designed to detect a signal that PBF-677 is safe and active on decreasing levels of faecal calprotectin, as well as preliminary evidence of ameliorate the Partial Mayo Clinical Score in colitis patients who are in flare of the disease. The Population Under Study will be: Around 30 subjects. Adults (18-75 years old) non-immunosuppressed patients with mild to moderate active ulcerative colitis disease.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	PBF-677	oral small molecule, antagonist of Adenosine A3 receptor (AA3R)
DRUG	Placebo oral capsule	Oral capsules

Timeline

• Start date: 2018-07-01
• Primary completion: 2021-05-27
• Completion: 2021-05-27
• First posted: 2018-12-12
• Last updated: 2022-01-13

Locations

1 site across 1 country: Spain