Phase II Study of HMPL-004 in Patients With Ulcerative Colitis

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: HMPL-004
  • HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day), 600 mg (3 x 200 mg t.i.d. or placebo.
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: placebo
  • placebo
• Experimental: low dose
• Experimental: high dose

Primary Measures

• clinical response
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• safety
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Have active confirmed mild to moderate ulcerative colitis

Exclusion Criteria:

• Diagnosed with Crohn's Disease or

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Hutchison Medipharma Limited Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00659802

Study ID Number: HMPL-004-US-02

ClinicalTrials.gov Identifier: NCT00659802

Health Authority: United States: Food and Drug Administration