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Completed

NCT Number: NCT00659802

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have active confirmed mild to moderate ulcerative colitis

Exclusion criteria

  • Diagnosed with Crohn's Disease or

Treatment and study plan

HMPL-004 low dose

Drug

HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).

Other names: Chuan xinlian

Placebo

Drug

Matching dose of Placebo

HMPL-004 high dose

Drug

HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).

Other names: Chuan xinlian

Primary outcomes

  1. Number of Participants With a Clinical Response at Week 8

    Time frame: 8 weeks

    Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1.

    The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.

Secondary outcomes

  1. Number of Participants With a Clinical Remission at Week 8

    Time frame: 8 weeks

    The percentage of subjects exhibiting clinical remission (Mayo score ≤2 with no individual score >1) at week 8.

    The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.

  2. Number of Participants With Mucosal Healing at Week 8

    Time frame: 8 weeks

    The percentage of subjects achieving Mucosal Healing at week 8. Mucosal Healing was defined as a significant decrease from baseline in the Mayo endoscopy sub-score ≥1 and absolute score ≤1. Mayo endoscopy sub-score ranges from 0 to 12. The higher score means a higher disease activity or worse outcome.

Sponsors and collaborators

Lead sponsor

Hutchison Medipharma Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 16, 2008
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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