| Trial ID: | L0436 |
| Source ID: | NCT04267393
|
| Associated Drug: |
BMS-986263
|
| Title: |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: BMS-986263;Other: Placebo
|
| Outcome Measures: |
Proportion of participants who achieve = 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score)Proportion of participants with = 1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by = 1 point;Proportion of participants with = 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score);Proportion of participants with = 1 stage improvement in modified Ishak liver fibrosis score;Proportion of participants with = 2 stage improvement in modified Ishak liver fibrosis score;Change from baseline in collagen proportionate area (CPA);Incidence of Adverse Events (AEs);Incidence of Serious Adverse Events (SAEs);Incidence of clinically significant changes in clinical laboratory values: Hematology tests;Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests;Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests;Incidence of clinically significant changes in vital signs: Body temperature;Incidence of clinically significant changes in vital signs: Respiratory rate;Incidence of clinically significant changes in vital signs: Blood pressure;Incidence of clinically significant changes in vital signs: Heart rate;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval;Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval;Incidence of clinically significant changes in physical examination;Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan;Plasma concentrations of components of BMS-986263 for injection
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb
|
| Gender: |
All
|
| Age: |
21 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
270
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
11/02/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
28 February 2022
|
| Locations: |
United States;Argentina;Belgium;Brazil;Canada;Germany;Israel;Italy;Japan;Korea, Republic of;Puerto Rico;Spain;Switzerland;Taiwan;United Kingdom;Argentina;Belgium;Brazil;Canada;Germany;Israel;Italy;Japan;Korea, Republic of;Puerto Rico;Spain;Switzerland;Taiwan;United Kingdom;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04267393
|
