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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01514240 | Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan | PHASE3 | COMPLETED | 123 | — | — | Feb 1, 2012 | Sep 1, 2014 | Oct 31, 2016 | 25 | Japan |
| NCT00573469 | Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | PHASE2 | COMPLETED | 75 | — | — | Oct 1, 2006 | Mar 1, 2008 | Jul 12, 2012 | 22 | Japan |
For the primary efficacy variable "Remission after 8 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.
Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.
| Arm | Type | Description |
|---|---|---|
| D9421-C | EXPERIMENTAL | D9421-C 9 mg once daily |
| Mesalazine | ACTIVE_COMPARATOR | Mesalazine 1 g three times a day |
| 1 | ACTIVE_COMPARATOR | D9421-C 9 mg |
| 2 | ACTIVE_COMPARATOR | D9421-C 15 mg |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| D9421-C capsule 3 mg | DRUG | Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. |
| Mesalazine tablets | DRUG | Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. |
| D9421-C, 9mg | DRUG | D9421-C 9 mg was given once daily for 8 weeks. |
| D9421-C, 15mg | DRUG | D9421-C 15 mg was given once daily for 8 weeks. |
| Placebo | DRUG | D9421-C matching placebo was given once daily for 8 weeks. |
Inclusion Criteria: * 15 years of age or older * Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation ...