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BMS-986263 for Nonalcoholic Steatohepatitis
Study Summary
This trial will test a new drug to see if it is safe and effective in adults with compensated cirrhosis from NASH.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 61 Patients • NCT03420768Trial Design
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Who is running the clinical trial?
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- I agree to use birth control methods.My liver biopsy within the last year shows severe scarring.I agree to use birth control methods.I have a condition that weakens my immune system.I have previously been treated with BMS-986263.My liver is not working properly.There are other requirements that you must meet or cannot meet to be part of the study, as specified in the study guidelines.My liver biopsy shows severe scarring done within the last 6 months.I have abnormal test results that my doctor is concerned about.My liver disease is getting worse or I have a condition that could make the trial unsafe for me.
- Group 1: Placebo
- Group 2: Dose A BMS-986263
- Group 3: Dose B BMS-986263
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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