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

Ulcerative Colitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659802
• Other study ID #: HMPL-004-US-02
• Status: Completed
• Phase: Phase 2
• Start date: February 7, 2008
• Est. completion date: October 13, 2009

Study information

• Verified date: July 2020
• Source: Hutchison Medipharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: October 13, 2009
• Est. primary completion date: October 13, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have active confirmed mild to moderate ulcerative colitis

Exclusion Criteria:

• Diagnosed with Crohn's Disease or

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Clinical Response at Week 8	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.	8 weeks
Secondary	Number of Participants With a Clinical Remission at Week 8	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.	8 weeks
Secondary	Number of Participants With Mucosal Healing at Week 8	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.	8 weeks