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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01951326 | Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease | PHASE3 | COMPLETED | 331 | — | — | Sep 1, 2013 | Aug 1, 2019 | Dec 8, 2020 | 103 | United States, Australia +8 |
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
| Arm | Type | Description |
|---|---|---|
| RHB-104 | ACTIVE_COMPARATOR | 5 RHB-104 capsules administered orally BID |
| Placebo | PLACEBO_COMPARATOR | 5 placebo capsules administered orally BID |
| Name | Type | Description |
|---|---|---|
| RHB-104 | DRUG | 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine |
| Placebo | DRUG | 5 placebo capsules administered orally BID |
Inclusion Criteria 1. Signed fully informed consent provided as per this protocol. 2. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study. 3. CD involving the ileum and/or colon 4. Moderately to severely active ...