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
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
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 1800 mg/day Drug: Placebo Drug: HMPL-004 2400 mg/day||Phase 3|
This Phase III study of HMPL-004 was to enroll approximately 420 subjects with active mild to moderate ulcerative colitis (UC; modified Mayo Score 4-10 and endoscopy score of 2-3). The trial included male and female subjects aged 18 or older. Subjects were currently receiving ≥2.4 g/day mesalamine or equivalent, provided they had taken 5-aminosalicylate (ASA; i.e., mesalamine) at a dose ≥2.4 g/day for at least 6 weeks prior to randomization and were on a stable dosage for at least 2 weeks prior to entering the screening phase of the study.
Qualifying subjects who entered into this study received 3 daily doses of oral HMPL 004 tablets or placebo for 56 days (8 weeks). There were 3 arms in this study consisting of placebo, HMPL-004 600 mg three times a day (TID) or 800 mg TID. Approximately 420 subjects were to be randomized 1:1:1 to one of these 3 arms, stratified by country/region in up to 150 clinical centers in North America, Europe, and Asia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Subjects were randomized according to a stratified blocked randomization schedule generated by an unblinded biostatistician. Stratification was by country/region and modified Mayo Score at screening using an interactive web-based response system (IWRS).|
|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|
|Actual 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
Subjects randomized to the arm of Placebo will receive matching Placebo three times daily for 56 days (8 weeks).
Experimental: HMPL-004 1800 mg/day
1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day
Drug: HMPL-004 1800 mg/day
Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg TID (total dose 1800 mg/day) for 56 days (8 weeks).
Other Name: Chuan xinlian
Experimental: HMPL-004 2400 mg/day
2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times per day
Drug: HMPL-004 2400 mg/day
Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg TID (total dose 2400 mg/day) for 56 days (8 weeks).
Other Name: Chuan xinlian
- Percentage of Subjects With a Clinical Remission at Week 8 [ Time Frame: 8 weeks ]Clinical remission was defined as a total Mayo Score of ≤2 points with no individual sub-score >1 point and rectal bleeding score = 0.
- The Proportion of Subjects With Clinical Response at Week 8 [ Time Frame: 8 weeks ]Clinical response was defined as a decrease in a modified Mayo Score from baseline by ≥3 points and ≥30% decrease in the modified Mayo Score, along with either a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1.
- The Proportion of Subjects With Mucosal Healing at Week 8 [ Time Frame: 8 weeks ]Mucosal healing was defined as having normal or inactive disease using a modified Mayo Score to determine if the decrease in the modified Mayo endoscopy sub-score from baseline was ≥1 in at least 1 segment and had an absolute score ≤1 in all segments.
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, 01001|
|Study Director:||Rongjun Liu, MD||Hutchison MediPharma|