NCT04504383

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Ulcerative Colitis Chronic Moderate
• Ulcerative Colitis Chronic Severe

Interventions

Type	Name	Description
DRUG	PN-943	Administered by the oral route BID for the duration of the study.
DRUG	Placebo	Administered by the oral route BID for 12 weeks.

Timeline

• Start date: 2020-08-05
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2020-08-07
• Last updated: 2023-04-25

Locations

122 sites across 13 countries: United States, Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Poland, Russia, Serbia, South Korea, Ukraine

Regulatory

• FDA-regulated drug study