At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 224 enrolled
Drug / intervention
HMPL-004 low dose +2 moredrug
Likely dose
HMPL-004 low dose 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating HMPL-004 low dose, Placebo, and 1 other intervention for Ulcerative Colitis. Completed, enrolled 224 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedApr 2008
Primary CompletionOct 2009
TodayJul 2026
First PostedApr 16, 2008
Enrollment StartFeb 7, 2008
Primary CompletionOct 13, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.2 years ago
Interventions
HMPL-004 low dosedrug
HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
Placebodrug
Matching dose of Placebo
HMPL-004 high dosedrug
HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).