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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06733519 | TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis | PHASE2 | NOT YET_RECRUITING | 40 | — | — | Jun 1, 2026 | Jun 1, 2027 | Sep 9, 2025 | - | — |
Percentage of participants with treatment-related adverse events as coded by MedDRA.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | - |
| Control | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Nalmefene | DRUG | Th-104 Nalmefene Mucoadhesive Buccal strip |
| Placebo | DRUG | Matching placebo to TH-104 |
Inclusion Criteria: 1. Men or women aged 18 to 75 years, inclusive, at the time of signing the informed consent form. 2. Diagnosis of PBC, as demonstrated by the participant presenting with at least 2 of the following criteria at the Screening Visit: 1. history of sustained increased alkaline p...