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

NCT00655733 | Completed Phase 2 Results

• 1 other identifier: 200500401
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• CDAI Clinical Response -100 at Week 8

  Percentage of subjects with CDAI clinical response -100 at Week 8 based on ITT population using the WOCF method to impute missing CDAI scores at Week 8. Clinical response -100 was defined as CDAI score decrease of ≥100 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8. The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome.

  8 weeks

Secondary Outcomes (11)

• Clinical Response -100 at Weeks 4

  4 weeks

• Clinical Response -100 at Weeks 12

  12 weeks

• Remission at Week 4

  4 weeks

• Remission at Week 8

  8 weeks

• Remission at Week 12

  12 weeks

Study Arms (2)

HMPL-004

EXPERIMENTAL

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.

Drug: HMPL-004

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

HMPL-004 DRUG

HMPL-004 1200 mg/d

Also known as: Chuan xinlian

HMPL-004

Placebo DRUG

Placebo 1200 mg/d

Placebo

Eligibility Criteria

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

You may qualify if:

• Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

Andrographis paniculata extract

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Hua Mu,Senior Vice President of Clinical Research and Development
• Organization: Hutchison MediPharma

huam@hmplglobal.com

861 3564487805

Study Officials

• Rongjun Liu, MD

  Hutchison Medipharma Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 6, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 2, 2020
• Results First Posted: December 3, 2012

Record last verified: 2018-08