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

HUTCHMED

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: HMPL-004

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655733

200500401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups, including a placebo group

HMPL-004

Experimental group

Description:

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.

Treatment:

Drug: HMPL-004

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo