Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986263 · 3 trials · 4 indications
The number of participants who achieve ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders. Activity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity Fibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis
measured by incidences
measured by incidences
measured by incidences
measured by incidences
measured by incidences
measured by incidences
measured by incidences
| Arm | Type | Description |
|---|---|---|
| Part 1 BMS-986263 45mg weekly | EXPERIMENTAL | - |
| Part 1 BMS-986263 90mg weekly | EXPERIMENTAL | - |
| Part 1 Placebo weekly | PLACEBO_COMPARATOR | - |
| Part 2 BMS-986263 45mg every 2 weeks | EXPERIMENTAL | - |
| Part 2 BMS-986263 90mg every 2 weeks | EXPERIMENTAL | - |
| Part 2 BMS-986263 90mg every 4 weeks | EXPERIMENTAL | - |
| Part 2 Placebo every 2 weeks | PLACEBO_COMPARATOR | - |
| Group A: Mild Hepatic Impairment | EXPERIMENTAL | Part 1 |
| Group B: Moderate Hepatic Impairment | EXPERIMENTAL | Part 1 |
| Group C: Severe Hepatic Impairment | EXPERIMENTAL | Part 2 |
| Group D: Normal Hepatic function (control group) | EXPERIMENTAL | Part 1 |
| Group E: Normal Hepatic Function (optional, control group) | EXPERIMENTAL | Part 2 |
| BMS-986263 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BMS-986263 | DRUG | Administered by intravenous (IV) infusion |
| Placebo | OTHER | Administered by intravenous (IV) infusion |
| Diphenhydramine | DRUG | 50 mg intravenous administration |
| Famotidine | DRUG | 20 mg intravenous administration |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is de...
BMS-986263 is an investigational small molecule being studied for hepatic impairment, fibrosis, and hepatic cirrhosis. It has been evaluated in clinical trials for conditions including advanced hepatic fibrosis after cure of hepatitis C, liver fibrosis, and varying degrees of liver impairment.
BMS-986263 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored clinical trials of the drug in the United States.
BMS-986263 is in clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study in adults with advanced hepatic fibrosis after cure of hepatitis C. The drug remains investigational and is not approved.
BMS-986263 has completed three clinical trials: NCT03142165, a Phase 1 multiple-dose study in healthy participants with fibrosis; NCT03420768, a Phase 2 study in adults with advanced hepatic fibrosis after cure of hepatitis C; and NCT04225936, a Phase 1 single-dose study in participants with varying degrees of liver impairment.
BMS-986263 is the primary name used in clinical trial records for this investigational small molecule. No alternative names are listed in the available trial information.