Phase II Study of HMPL-004 in Patients With Ulcerative Colitis

Last updated: July 6, 2020
Sponsor: Hutchison Medipharma Limited
Overall Status: Completed

Phase

2

Condition

Colic

Ulcerative Colitis

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT00659802
HMPL-004-US-02
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have active confirmed mild to moderate ulcerative colitis

Exclusion

Exclusion Criteria:

  • Diagnosed with Crohn's Disease or

Study Design

Total Participants: 224
Study Start date:
February 07, 2008
Estimated Completion Date:
October 13, 2009

Study Description

This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or matching placebo. Assessment of treatment effect is based on the Mayo score. Subjects eligible for the study will include those ≥18 years of age with mild to moderate ulcerative colitis, having a Mayo score of 4 to 10, with activity confirmed by endoscopy within 2 weeks prior to study entry, and having a Mayo endoscopy score ≥1. Subjects who are using concomitant mesalamine could enter the study. The randomization will be stratified by mesalamine use or non-use.