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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04950127 | Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) | PHASE3 | COMPLETED | 238 | — | — | Aug 27, 2021 | Dec 20, 2024 | Jul 22, 2025 | 114 | United States, Argentina +17 |
| NCT05435170 | Food Effect Study of Linerixibat Tablets in Healthy Adult Participants | PHASE1 | COMPLETED | 23 | — | — | Aug 11, 2022 | Oct 10, 2022 | Nov 29, 2022 | 1 | United Kingdom |
| NCT05393076 | Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls | PHASE1 | COMPLETED | 8 | — | — | Jul 19, 2022 | Dec 6, 2022 | Jan 18, 2023 | 2 | United States |
Itch Scores were assessed using a NRS twice daily, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. The monthly itch score was defined as the worst weekly itch score for the month (4 weeks). Higher monthly itch scores indicate worse itching. Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. Least-squares (LS) means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly itch scores obtained over 24 weeks using equal weighting for all time points. Analyzed using Mixed Model Repeated Measures (MMRM) method.
| Arm | Type | Description |
|---|---|---|
| Part A: Linerixibat 40 milligrams (mg) | EXPERIMENTAL | Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24). |
| Part A: Placebo | EXPERIMENTAL | Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24). |
| Part B: Placebo in Part A and Part B | PLACEBO_COMPARATOR | Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B. |
| Part B: Placebo in Part A and Linerixibat 40 mg in Part B | EXPERIMENTAL | Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B. |
| Part B: Linerixibat 40 mg in Part A and Placebo in Part B | EXPERIMENTAL | Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B. |
| Part B: Linerixibat 40 mg in Part A and Part B | EXPERIMENTAL | Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B. |
| Treatment sequence AB | EXPERIMENTAL | Participants will receive linerixibat in fed state (Treatment A) in period 1 followed by linerixibat in fasted state (Treatment B) in period 2. The washout period will be of at least 7 days. |
| Treatment sequence BA | EXPERIMENTAL | Participants will receive linerixibat in fasted state (Treatment B) in period 1 followed by linerixibat in fed state (Treatment A) in period 2. The washout period will be of at least 7 days. |
| Cohort 1 (Moderate hepatic impairment participants) | EXPERIMENTAL | Eligible participants to receive single dose of linerixibat. |
| Cohort 2 (Matched healthy control participants) | EXPERIMENTAL | Eligible participants to receive single dose of linerixibat |
| Name | Type | Description |
|---|---|---|
| Linerixibat | DRUG | Participants will receive linerixibat. |
| Placebo | DRUG | Participants will receive placebo. |
Inclusion Criteria: * Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent. * Participants who have documented PBC. * Participants who have moderate to severe itch. Exclusion Criteria: * Total bilirubin \>2.0 times Upper Limit o...