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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03394924 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis | PHASE2 | COMPLETED | 68 | — | — | Dec 27, 2017 | Jan 16, 2020 | May 18, 2021 | 86 | United States, Australia +8 |
Percent change was calculated as \[(ALP at Week 12 - ALP at Baseline)/ALP at Baseline\] \*100. The participant was considered to have successfully achieved a 20% reduction in ALP if the result was ≤-20. The participant was considered to have successfully achieved ALP normalization if ALP was abnormal at Baseline and normal at Week 12.
| Arm | Type | Description |
|---|---|---|
| EDP-305 1 mg | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| EDP-305 2.5 mg | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Subjects will take two tablets once a day orally for 12 weeks |
| Name | Type | Description |
|---|---|---|
| EDP-305 1 mg | DRUG | Two tablets daily for 12 weeks |
| EDP-305 2.5 mg | DRUG | Two tablets daily for 12 weeks |
| Placebo | DRUG | Two tablets daily for 12 weeks |
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at...