A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis — PULSE  

Ulcerative Colitis Clinical Trial

Official title: A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis.

Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.

Clinical Trial Description

This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.

Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration of the study will be 20 weeks, excluding the screening period.

The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active UC.

The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with active UC on:

• Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of treatment.

• Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in subjects with active UC.

• Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC

• Endoscopic: Trends in endoscopic disease activity in subjects with active UC. ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT03849599
• Study type: Interventional
• Source: Provention Bio, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2018
• Completion date: March 1, 2019