A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
Summary
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.
Timeline
- Start
- 2013-03
- Primary completion
- 2014-10
- Completion
- 2014-10
Outcome
Missed primary endpoint
Stopped: “Interim futility analysis results”
release “Interim analysis on HMPL-004 NATRUL-3 Phase III study showed, despite a solid safety profile, no overall efficacy benefit was observed so the study was terminated.” hutch-med.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | andrographolide | Small molecule | 600 mg | Oral |
| Subject | andrographolide | Small molecule | 800 mg | Oral |