Trial Details

Not Recruiting
Basic Information
Clinical ID c2550
Identifier EUCTR2019-004469-41-DE
Trial 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
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1_Level: LLT_Classification code 10045365_Term: Ulcerative colitis_System Organ Class: 100000004856_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Product Code: PN-943 Pharmaceutical Form: Tablet Current Sponsor code: PN-943 Other descriptive name: PN-943 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: PN-943 Pharmaceutical Form: Tablet Current Sponsor code: PN-943 Other descriptive name: PN-943 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Participant Information
Sponsor Protagonist Therapeutics, Inc
City -
Country/Region Russia;Hungary;United States;Ukraine;Canada;Austria;South Korea;Poland;Italy;Georgia;Serbia;Bulgaria;Germany
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE2
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -