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

NCT01882764 | Terminated Phase 3 Results

• 1 other identifier: HMPL-004-04
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• The Proportion of Subjects Achieving Clinical Remission

  Clinical remission is defined as a modified Mayo Score ≤2 along with no individual score \>1 AND rectal bleeding score = 0.

  52 weeks

Study Arms (2)

HMPL-004 1800 mg/day

EXPERIMENTAL

Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks. Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.

Drug: HMPL-004

Placebo

PLACEBO COMPARATOR

Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks. Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.

Drug: Placebo

Interventions

HMPL-004 DRUG

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.

Also known as: Chuan xinlian

HMPL-004 1800 mg/day

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of induction study HMPL-004-03 or HMPL-004-05 and achieving clinical remission or response with no disruption of study treatment in the transition to HMPL-004-04, or, for the open label induction phase of the study: have active mild to moderate Ulcerative Colitis defined by a modified Mayo Score of 4 to 10 and with endoscopy score activity of 2-3 points confirmed by a full colonoscopy within 2 weeks prior to study.
• Subjects must be currently receiving mesalamine ≥ 2.4 g/day (or the equivalent) for at least 6 weeks prior to randomization and on a stable dosage for at least 2 weeks prior to entering the screening phase of the study to ensure a stable dose is established at least 2 weeks prior to the endoscopic procedures.

You may not qualify if:

• Age ≥ 18 years
• All fertile male and female subjects must agree to use one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one and continues for the duration of the trial, contraceptive patch, or condom with spermicide.
• Show evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
• Subjects with intolerance to mesalamine (or equivalent medications).
• Diagnosed with Crohn's disease or with lesions such as fistulas or granulomas on biopsy noted either in history or at baseline endoscope, which would be suspicious for Crohn's disease, or with a diagnosis of indeterminate colitis.
• Severe disease with a Ulcerative Colitis modified Mayo Clinic score above 10 points at baseline.
• Positive stool test for pathogens on sample taken within the 2 weeks prior to study entry.
• Active clostridium difficile (C. diff) infection.
• Use of Inflammatory Bowel Disease related herbal supplements including supplements containing andrographis or the use of probiotics two weeks prior to study entry or during the study.
• Toxic megacolon or toxic colitis.
• Probable requirement for intestinal surgery within 12 weeks after the start of investigational product.
• Receiving oral or rectal steroids within 1 month prior to study entry.
• Receiving rectal mesalamine within 1 week prior to study entry.
• Receiving azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, or other immunosuppressive therapy at the time of screening or within the preceding 6 weeks.
• Receiving anti-tumor necrosis factor-α (TNF-α)agents such as infliximab, adalimumab, golimumab, or certolizumab pegol at the time of screening or within the preceding 8 weeks.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead
• Nutrition Science Partners Limited: collaborator

Study Sites (1)

Clinical Research Management, Inc.

Agawam, Massachusetts, 01001, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Andrographis paniculata extract

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr. Rongjun Liu
• Organization: Hutchison MediPharma Ltd

rongjunl@hmplglobal.com

+86 21 2067 3203

Study Officials

• Liu Rongjun, Dr.

  Hutchison Medipharma Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 20, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-02

Locations

US (1)