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

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: HMPL-004 high dose; Drug: HMPL-004 low dose; Drug: Placebo

• Registration Number: NCT00659802
• Lead Sponsor: Hutchison Medipharma Limited

Brief 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.

Study Timeline

• Study Start: 2008-02-07
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Primary Completion: 2009-10-13
• Study Completion: 2009-10-13
• Results First Submitted: 2019-12-09
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Results First Posted: 2020-07-22
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• Have active confirmed mild to moderate ulcerative colitis

Exclusion Criteria

• Diagnosed with Crohn's Disease or

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMPL-004 high dose	HMPL-004 high dose	A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.
HMPL-004 low dose	HMPL-004 low dose	A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.
placebo	Placebo	Matching dose of placebo will be given orally in capsules three times per day for 56 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Clinical Response at Week 8	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 Outcome Measures

Name	Time	Method
Number of Participants With Mucosal Healing at Week 8	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.
Number of Participants With a Clinical Remission at Week 8	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.