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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04663308 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) | PHASE2 | ACTIVE NOT_RECRUITING | 182 | — | — | Dec 18, 2020 | Apr 1, 2027 | Feb 4, 2026 | 103 | United States, Argentina +12 |
The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.
| Arm | Type | Description |
|---|---|---|
| Part 1 Arm 1: Volixibat 20mg | EXPERIMENTAL | Participants randomized to this arm will receive volixibat 20mg twice daily. |
| Part 1 Arm 2: Volixibat 80mg | EXPERIMENTAL | Participants randomized to this arm will receive volixibat 80mg twice daily. |
| Part 1 Arm 3: Placebo | PLACEBO_COMPARATOR | Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily. |
| Part 2 Arm 1: Volixibat Selected Dose 20mg | EXPERIMENTAL | Participants randomized to this arm will receive volixibat 20mg twice daily. |
| Part 2 Arm 2: Placebo | PLACEBO_COMPARATOR | Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily. |
| Name | Type | Description |
|---|---|---|
| Volixibat | DRUG | Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor. |
| Placebo | DRUG | Capsules matched to study drug minus active substance |
Inclusion Criteria: 1. Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period. 2. Subjects aged ≥12 years for eligible regions; otherwise ≥18 years 3. Confirmed diagnosis ...