Phase II Study of HMPL-004 in Subjects With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00655733
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : December 3, 2012
Last Update Posted : December 3, 2012
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief Summary:
Double-blind, randomized, multicenter, placebo-controlled study The purpose of this study is to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's Disease,compared with placebo.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: HMPL004 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2006
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: HMPL004
HMPL004 1200mg/d
Drug: HMPL004
HMPL004 1200mg/d
Placebo Comparator: placebo
Drug: Placebo

Primary Outcome Measures :
  1. The Efficacy of HMPL 004 Given at 1200 mg/Day, Assessed After 8 Weeks of Treatment With HMPL-004 in Inducing a Drop in the Subject's Crohn's Disease Activity Index (CDAI) by 100 Points. [ Time Frame: 8 weeks ]
    For the Intention to Treat (ITT) population, the Worst Observation Carried Forward (WOCF) method, was used to measure the percentage of subjects in the HMPL 004 group as compared to the placebo group that achieved a clinical response of a CDAI reduction of 100 points at Week 8 as compared to the subject's entry level CDAI score.

Secondary Outcome Measures :
  1. Safety [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen

Exclusion Criteria:

  • They have received anti-TNF-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of starting study medication

Responsible Party: Hutchison Medipharma Limited Identifier: NCT00655733     History of Changes
Other Study ID Numbers: 200500401
First Posted: April 10, 2008    Key Record Dates
Results First Posted: December 3, 2012
Last Update Posted: December 3, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases