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
1 other identifier
interventional
224
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2009
CompletedResults Posted
Study results publicly available
July 22, 2020
CompletedJuly 22, 2020
July 1, 2020
1.7 years
April 8, 2008
December 9, 2019
July 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Participants With a Clinical Remission at Week 8
8 weeks
Number of Participants With Mucosal Healing at Week 8
8 weeks
Study Arms (3)
placebo
PLACEBO COMPARATORMatching dose of placebo will be given orally in capsules three times per day for 56 days.
HMPL-004 low dose
EXPERIMENTALA 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.
HMPL-004 high dose
EXPERIMENTALA 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.
Interventions
HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).
Eligibility Criteria
You may qualify if:
- Have active confirmed mild to moderate ulcerative colitis
You may not qualify if:
- Diagnosed with Crohn's Disease or
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Rongjun Liu
- Organization
- Hutchison Medipharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 16, 2008
Study Start
February 7, 2008
Primary Completion
October 13, 2009
Study Completion
October 13, 2009
Last Updated
July 22, 2020
Results First Posted
July 22, 2020
Record last verified: 2020-07