Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ND-L02-s0201 Injection
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 the treatment of fibrosis, hepatic cirrhosis, and hepatic impairment. It has been evaluated in clinical trials involving healthy participants and adults with advanced hepatic fibrosis after cure of hepatitis C.
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 an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not approved by the FDA and remains in clinical development.
BMS-986263 has been studied in three completed trials: NCT03142165, a Phase 1 multiple-dose study in healthy participants; 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 sole name used for this investigational small molecule in the clinical trial records. No alternative names have been reported for the drug.