Status:

COMPLETED

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

Lead Sponsor:

Hutchison Medipharma Limited

Conditions:

Crohn's Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

A double blind, randomized, multi-center, placebo-controlled study to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's Disease.

Detailed Description

This was a double-blind, randomized, multicenter, placebo-controlled study evaluating the efficacy and safety of oral HMPL-004 in subjects with active moderate Crohn's disease (CD) - Crohn's Disease A...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT00655733

Start Date

April 1 2006

End Date

April 1 2009

Last Update

January 2 2020

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