Double-blind, Randomized, Multicenter, Placebo-controlled Phase II Study of Efficacy and Safety of HMPL-004 in Subjects With Active Moderate Crohn's Disease
Overview
- Phase
- Phase 2
- Intervention
- HMPL-004
- Conditions
- Crohn's Disease
- Sponsor
- Hutchison Medipharma Limited
- Enrollment
- 101
- Primary Endpoint
- CDAI Clinical Response -100 at Week 8
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Detailed Description
This was a double-blind, randomized, multicenter, placebo-controlled study evaluating the efficacy and safety of oral HMPL-004 in subjects with active moderate Crohn's disease (CD) - Crohn's Disease Activity Index (CDAI) 220 to 400 - on stable doses of CD medications who had not received anti-tumor necrosis factor alpha (anti-TNF-α) for at least 3 months prior to start of treatment. HMPL-004 (or placebo) was added to the subject's existing CD medications. Subjects were observed for an 8-week treatment period and a subsequent 4-week follow-up period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen
Exclusion Criteria
- •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
Arms & Interventions
HMPL-004
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.
Intervention: HMPL-004
Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
CDAI Clinical Response -100 at Week 8
Time Frame: 8 weeks
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.
Secondary Outcomes
- 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)
- Clinical Response -70 at Week 4(4 weeks)
- Clinical Response -70 at Week 8(8 weeks)
- Clinical Response -70 at Week 12(12 weeks)
- Complete Remission at Week 4(4 weeks)
- Complete Remission at Week 8(8 weeks)
- Complete Remission at Week 12(12 weeks)