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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02516605 | A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients | PHASE2 | COMPLETED | 61 | — | — | Sep 9, 2015 | Aug 2, 2018 | Jan 5, 2021 | 28 | United States, Canada +4 |
Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28
Vital signs - Systolic Blood pressure
Vital signs
Vital signs
Electrocardiogram (ECG)
Electrocardiogram (ECG)
Hematology panel for safety laboratory assessments.
| Arm | Type | Description |
|---|---|---|
| LJN452 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Part 1: LJN452 | DRUG | LJN452 capsules administered once daily for 28 days |
| Part 1: Placebo | DRUG | Matching placebo capsules administered once daily for 28 days |
| Part 2: LJN452 Dose level 1 | DRUG | LJN452 capsules administered once a day for 12 weeks |
| Part 2: Placebo | DRUG | Matching placebo to LJN452 administered once a day for 12 weeks |
| Part 2: LJN452 Dose level 2 | DRUG | LJN452 |
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of PBC as demonstrated by the presence of at least 2 of the following 3 diagnostic criteria: * History of alkaline phosphatase (ALP) elevated above upper limit of normal (ULN) for at least 6 months * Positive antimitochondrial antibodies (AMA) t...