NCT00655733

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

Double-blind, Randomized, Multicenter, Placebo-controlled Phase II Study of Efficacy and Safety of HMPL-004 in Subjects With Active Moderate Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Activity Index (CDAI) 220 to 400 - on stable doses of CD medications who had not received anti-tumor necrosis factor alpha (anti-TNF-α) for at least 3 months prior to start of treatment. HMPL-004 (or placebo) was added to the subject's existing CD medications. Subjects were observed for an 8-week treatment period and a subsequent 4-week follow-up period.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	HMPL-004	HMPL-004 1200 mg/d
DRUG	Placebo	Placebo 1200 mg/d

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-04-10
• Last updated: 2020-01-02
• Results posted: 2012-12-03