BMS-986263 for Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Alcoholic Fatty Liver Disease (NAFLD)BMS-986263 - Drug
Eligibility
21 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new drug to see if it is safe and effective in adults with compensated cirrhosis from NASH.

Eligible Conditions
  • Non-Alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 27 Secondary · Reporting Duration: Day 1 to week 12

At 12 weeks
Change from baseline in collagen proportionate area (CPA)
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 ≥ 1 stage improvement in modified Ishak liver fibrosis score
Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score)
Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score
Week 12
Plasma Concentrations of ({Bis[2-(tetradecanoyloxy)ethyl] carbamoyl}methyl)-(2-hydroxyethyl) dimethylazanium bromide (HEDC)
Plasma concentrations of components of BMS-986263 for injection
Plasma concentrations of di-retinamide-PEG-di-retinamide (DPD)
Plasma concentrations of lipid component (S104)
Plasma
Up to week 36
Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Electrocardiogram
Electrocardiogram
Electrocardiogram
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval
Electrocardiogram
Incidence of clinically significant changes in physical examination
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in vital signs: Respiratory rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

BMS-986263 45 mg QW (Once Weekly)
33%Infusion related reaction
11%Headache
6%Tendonitis
6%Abulia
6%Upper respiratory tract infection
6%Hypothyroidism
6%Vulvovaginal candidiasis
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03420768) in the BMS-986263 45 mg QW (Once Weekly) ARM group. Side effects include: Infusion related reaction with 33%, Headache with 11%, Tendonitis with 6%, Abulia with 6%, Upper respiratory tract infection with 6%.

Trial Design

3 Treatment Groups

Dose B BMS-986263
1 of 3
Dose A BMS-986263
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

270 Total Participants · 3 Treatment Groups

Primary Treatment: BMS-986263 · Has Placebo Group · Phase 2

Dose B BMS-986263
Drug
Experimental Group · 1 Intervention: BMS-986263 · Intervention Types: Drug
Dose A BMS-986263
Drug
Experimental Group · 1 Intervention: BMS-986263 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986263
2020
Completed Phase 2
~140

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to week 12

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,496 Previous Clinical Trials
3,930,057 Total Patients Enrolled

Eligibility Criteria

Age 21 - 75 · All Participants · 2 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Iowa100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Local Institution100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%