NCT03849599

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Provention Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	PRV-300	Treatment
BIOLOGICAL	Placebo	Control

Timeline

• Start date: 2018-02-21
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2019-02-21
• Last updated: 2020-02-13

Locations

3 sites across 3 countries: Georgia, Moldova, Ukraine