A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- The Efficacy of HMPL-004 in patients taking mesalamine as compared to placebo. [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||March 2013|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805791
|United States, Massachusetts|
|Clinical Research Management, Inc|
|Agawam, Massachusetts, United States|