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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00659802
Study type	Interventional
Source	Hutchison Medipharma Limited
Contact
Status	Completed
Phase	Phase 2
Start date	February 7, 2008
Completion date	October 13, 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05702879` - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting	`NCT05953402` - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Recruiting	`NCT03950232` - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	Phase 3
Completed	`NCT03124121` - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels	Phase 4
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Withdrawn	`NCT04209556` - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis	Phase 2
Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Recruiting	`NCT04398550` - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis	N/A
Recruiting	`NCT04314375` - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	Phase 4
Active, not recruiting	`NCT04857112` - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis	Phase 2
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting	`NCT04033445` - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	Phase 2/Phase 3
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting	`NCT06221995` - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting	`NCT04767984` - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis	Phase 2
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT06071312` - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach	Phase 1/Phase 2
Completed	`NCT03760003` - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis	Phase 2
Not yet recruiting	`NCT05539625` - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis	Phase 2