Phase II Study of HMPL-004 in Patients With Ulcerative Colitis

HUTCHMED

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: HMPL-004 low dose; Drug: HMPL-004 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00659802

HMPL-004-US-02

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.

Full description

This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or matching placebo. Assessment of treatment effect is based on the Mayo score. Subjects eligible for the study will include those ≥18 years of age with mild to moderate ulcerative colitis, having a Mayo score of 4 to 10, with activity confirmed by endoscopy within 2 weeks prior to study entry, and having a Mayo endoscopy score ≥1. Subjects who are using concomitant mesalamine could enter the study. The randomization will be stratified by mesalamine use or non-use.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have active confirmed mild to moderate ulcerative colitis

Exclusion criteria

• Diagnosed with Crohn's Disease or

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

224 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Matching dose of placebo will be given orally in capsules three times per day for 56 days.

Treatment:

Drug: Placebo

HMPL-004 low dose

Experimental group

Description:

A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.

Treatment:

Drug: HMPL-004 low dose

HMPL-004 high dose

Experimental group

Description:

A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.

Treatment:

Drug: HMPL-004 high dose