A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT01805791|
Recruitment Status : Terminated (Interim futility analysis results)
First Posted : March 6, 2013
Last Update Posted : August 1, 2018
A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication.
The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: HMPL-004 tablet Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Placebo Comparator: Placebo
Placebo, oral tablets, three times a day
Placebo tablets will be used in the placebo arm of the study.
Experimental: 1800 mg/day HMPL-004
1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day
Drug: HMPL-004 tablet
Experimental: 2400 mg/day
2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times per day
Drug: HMPL-004 tablet
- The Efficacy of HMPL-004 in patients taking mesalamine as compared to placebo. [ Time Frame: After 8 weeks of treatment ]Patients will be evaluated for their change of disease activity after 8 weeks of treatment by means of a Modified Mayo Scoring system. Patients will be evaluated at week 8 for disease remission. For the current study, the definition of remission has been modified. The remission is defined as a total Mayo Score of < 2 points with no individual sub-score > 1 point AND rectal bleeding score = 0. For remission, the endoscopy will have no friability (meaning a score of 0 or 1). The endoscopy score has been modified such that any degree of friability will be scored as a 2 or greater. Safety will be assessed by the frequency, type and severity of Adverse Events during the 8 weeks of treatment for each dose of HMPL-004 used as compared to placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805791
|United States, Massachusetts|
|Clinical Research Management, Inc|
|Agawam, Massachusetts, United States|