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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03124108 | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | PHASE2 | COMPLETED | 45 | — | — | Apr 5, 2017 | Oct 31, 2018 | Sep 24, 2019 | 24 | United States, France +3 |
Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Elafibranor 80 mg | ACTIVE_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Elafibranor 120 mg | ACTIVE_COMPARATOR | Study subjects will take two tablets per day orally before breakfast with a glass of water each morning |
| Name | Type | Description |
|---|---|---|
| Elafibranor 80 mg | DRUG | Two coated tablets daily for 12 weeks |
| Elafibranor 120 mg | DRUG | Two coated tablets daily for 12 weeks |
| Placebo | DRUG | Two coated tablets daily for 12 weeks |
Inclusion Criteria: 1. Must have provided written informed consent 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: * History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit) * Positive...