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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00659802 | Phase II Study of HMPL-004 in Patients With Ulcerative Colitis | PHASE2 | COMPLETED | 224 | — | — | Feb 7, 2008 | Oct 13, 2009 | Jul 22, 2020 | - | — |
Clinical response at week 8, which is a decrease in the Mayo score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1. The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency (0-3), rectal bleeding (0-3), endoscopic evaluation (0-3) and Physician's global assessment (0-3), ranging from 0 to 12. The higher score means a higher disease activity or worse outcome.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | Matching dose of placebo will be given orally in capsules three times per day for 56 days. |
| HMPL-004 low dose | EXPERIMENTAL | A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
| HMPL-004 high dose | EXPERIMENTAL | A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. |
| Name | Type | Description |
|---|---|---|
| HMPL-004 low dose | DRUG | HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). |
| Placebo | DRUG | Matching dose of Placebo |
| HMPL-004 high dose | DRUG | HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day). |
Inclusion Criteria: * Have active confirmed mild to moderate ulcerative colitis Exclusion Criteria: * Diagnosed with Crohn's Disease or