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BMS-986263 for Nonalcoholic Steatohepatitis

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months
Men and women must agree to follow methods of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 12
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for adults with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Participants must have a specific liver fibrosis score and agree to use contraception. Those with compromised immune systems, prior exposure to BMS-986263, hepatic decompensation, or other conditions that may risk safety are excluded.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of BMS-986263 compared to a placebo in treating liver disease caused by NASH. It's randomized, meaning participants will be randomly assigned to receive either the drug or a placebo without choosing which one.See study design
What are the potential side effects?
Potential side effects of BMS-986263 could include reactions at the injection site, changes in liver function tests, fatigue, gastrointestinal symptoms like nausea or diarrhea, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver biopsy within the last year shows severe scarring.
Select...
I agree to use birth control methods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score)
Secondary outcome measures
Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan
Change from baseline in collagen proportionate area (CPA)
Incidence of Adverse Events (AEs)
+20 more

Side effects data

From 2019 Phase 2 trial • 61 Patients • NCT03420768
33%
Infusion related reaction
11%
Headache
6%
Tendonitis
6%
Hypothyroidism
6%
Abulia
6%
Upper respiratory tract infection
6%
Vulvovaginal candidiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
BMS-986263 45 mg QW (Once Weekly)
Placebo QW (Once Weekly)
BMS-986263 90 mg QW (Once Weekly)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose B BMS-986263Experimental Treatment1 Intervention
Group II: Dose A BMS-986263Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986263
2020
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,126,412 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
780 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

BMS-986263 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04267393 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo, Dose A BMS-986263, Dose B BMS-986263
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: BMS-986263 Highlights & Side Effects. Trial Name: NCT04267393 — Phase 2
BMS-986263 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04267393 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How would you assess the hazard posed by BMS-986263?

"Based on the information we have, BMS-986263's safety has been rated a 2 as it is still in its second stage of trials and there are no data points supporting efficacy yet."

Answered by AI

Do I qualify for participation in this research?

"This experiment involves 270 individuals aged 21 to 75 diagnosed with cirrhosis of the liver. Additionally, all participants must have had a biopsy score assessment resulting in NASH CRN stage 4 within six months prior to joining, and both male and female enrollees must agree to use an accepted form of contraception during their involvement."

Answered by AI

Is the age range for this research limited to seniors or can younger individuals participate?

"This trial is recruiting individuals aged 21 and over, but younger than 75 years old."

Answered by AI

How many locations are participating in this investigation?

"Stanford Medicine Outpatient Center in Redwood City, California; UCSD - Altman Clinical and Translational Research Institute (ACTRI)-UC San Diego NAFLD Research Cent in La Jolla, Michigan; Local Institution in Wyoming, Florida as well as 31 additional medical facilities are accepting patients for this trial."

Answered by AI

What is the scope of participation in this medical experiment?

"To adequately conduct the study, Bristol-Myers Squibb must recruit 270 participants who meet all of the criteria. Locations hosting this trial include Stanford Medicine Outpatient Center in Redwood City and UCSD - Altman Clinical and Translational Research Institute (ACTRI)-UC San Diego NAFLD Research Cent in La Jolla."

Answered by AI

Are participants being accepted for this research project currently?

"Clinicaltrials.gov data reveals that this medical trial is still recruiting participants, having been listed on the 17th of March 2021 and modified most recently on October 25th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
How old are they?
18 - 65
What site did they apply to?
Local Institution
The Institute for Liver Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~31 spots leftby Mar 2025