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PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

Ulcerative Colitis Chronic Moderate Clinical Trial

Official title:
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis

Clinical Trial Summary

The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).

Clinical Trial Description

The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID. Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04504383
Study type Interventional
Source Protagonist Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date August 5, 2020
Completion date February 16, 2023
View Details
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