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HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis

NCT01882764 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-01-13

Study results available
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Summary

A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. Subjects are required to be in clinical remission or clinical response to enter the year long maintenance phase. This study will help evaluate if HMPL-004 is effective in subjects maintaining clinical remission following successful induction therapy achieving clinical remission or clinical response.

Conditions

Interventions

DRUG

HMPL-004

Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given HMPL-004 orally three times per day with total daily dose of 1800 mg for 52 weeks.

DRUG

Placebo

Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given Placebo orally three times per day with total daily dose of 1800 mg for 52 weeks.

Sponsors & Collaborators

  • Nutrition Science Partners Limited

    collaborator INDUSTRY

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Liu Rongjun, Dr. · Hutchison Medipharma Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01882764 on ClinicalTrials.gov