Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00655733 | Phase II Study of HMPL-004 in Subjects With Crohn's Disease | PHASE2 | COMPLETED | 101 | — | — | Apr 1, 2006 | Apr 1, 2009 | Jan 2, 2020 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| HMPL-004 | DRUG | HMPL-004 1200 mg/d |
| Placebo | DRUG | Placebo 1200 mg/d |
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...