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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HMPL-004

Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.

Group Type EXPERIMENTAL

HMPL-004

Intervention Type DRUG

HMPL-004 1200 mg/d

Placebo

Subjects who fulfilled all entry criteria and randomized Placebo arm will receive matching placebo 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1200 mg/d

Interventions

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HMPL-004

HMPL-004 1200 mg/d

Intervention Type DRUG

Placebo

Placebo 1200 mg/d

Intervention Type DRUG

Other Intervention Names

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Chuan xinlian

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No