NCT00659802

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

A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	HMPL-004 low dose	HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
DRUG	Placebo	Matching dose of Placebo
DRUG	HMPL-004 high dose	HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).

Timeline

• Start date: 2008-02-07
• Primary completion: 2009-10-13
• Completion: 2009-10-13
• First posted: 2008-04-16
• Last updated: 2020-07-22
• Results posted: 2020-07-22