Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
NCT ID: NCT04048876
Last Updated: 2023-06-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
56 participants
INTERVENTIONAL
2019-08-14
2021-09-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
NCT04583423
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
NCT04171765
A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
NCT06903065
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02704403
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
NCT03053063
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CC-90001 400 mg once daily (QD)
CC-90001 400 mg QD
CC-90001
oral
CC-90001 200 mg once daily
CC-90001 200 mg QD
CC-90001
oral
CC-90001 100 mg once daily
CC-90001 100 mg QD
CC-90001
oral
Placebo once daily
Placebo QD
Placebo
oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CC-90001
oral
Placebo
oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
3. Participant has urine ethyl glucuronide (EtG) \> 500 ng/mL at Screening.
4. History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency \[CVID\]).
5. History of hepatitis B and/or hepatitis C.
6. History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
7. Pregnancy or lactation.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute
Phoenix, Arizona, United States
Mayo Clinic Phoenix
Phoenix, Arizona, United States
UC San Diego School of Medicine
La Jolla, California, United States
Cedars-Sinai Comprehensive Transplant Center
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Southern California GI & Liver Centers
San Clemente, California, United States
University of Colorado, School of Medicine - Hepatology Clinic - Anschutz
Aurora, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Digestive Health Specialists
Lakewood Rch, Florida, United States
Local Institution - 176
Lakewood Rch, Florida, United States
University of Miami Schiff Center for Liver Diseases
Miami, Florida, United States
IMIC, Inc.
Palmetto Bay, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Rush University Medical Center - University Cardiovascular Surgeons
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
WestGlen Gastrointestinal Consultants, P.A.
Shawnee Mission, Kansas, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
The Institute for Digestive Health & Liver Disease at Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, PA
Catonsville, Maryland, United States
Boston University Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Louis University School of Medicine
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Beth Israel Medical Center
New York, New York, United States
Concorde Medical Group
New York, New York, United States
New York Presbyterian Hospital - Weill-Cornell
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Local Institution - 102
Chapel Hill, North Carolina, United States
UNC Hospitals GI Medicine Clinic
Chapel Hill, North Carolina, United States
Duke University School of Medicine
Durham, North Carolina, United States
Carolinas HealthCare System Digestive Health
Huntersville, North Carolina, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Pittsburgh Medical Center - Center for Liver Diseases
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Texas Clinical Research Institute LLC
Arlington, Texas, United States
Liver Institute at Methodist Dallas
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston, Texas, United States
Baylor College of Medicine - Baylor Heart Clinic
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Digestive Health Associates of Texas (DHAT)
Rockwell, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Vermont Medical Center Gastro
Burlington, Vermont, United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States
University of Washington Harborview Medical Center
Seattle, Washington, United States
Liver Institute Northwest PLLC
Seattle, Washington, United States
University of Sydney - Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
University of Calgary, Cumming School of Medicine
Calgary, Alberta, Canada
South Edmonton Gastroenterology
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Toronto Center for Liver Disease - Francis Family Liver Clinic
Toronto, Ontario, Canada
CHU d'Angers
Angers, , France
Assistance Publique - Hopitaux de Paris - Hopital Beaujon
Clichy, , France
Hopital de la Croix-Rousse
Lyon, , France
Assistance Publique - Hopitaux de Paris - Hopital Cochin
Paris, , France
Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
Paris, , France
Hopital Haut Leveque
Pessac, , France
Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou
Rennes, , France
Hopital Hautepierre
Strasbourg, , France
Local Institution - 356
Strasbourg, , France
Universitaetsklinikum der RWTH Aachen
Aachen, , Germany
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Hamamatsu University Hospital
Hamamatsu, , Japan
Local Institution - 604
Hamamatsu, , Japan
Local Institution - 608
Kashihara, , Japan
Nara Medical University Hospital
Kashihara, , Japan
Local Institution - 601
Kawasaki, , Japan
Shin-Yurigaoka General Hospital
Kawasaki, , Japan
Kurume University Hospital
Kurume, Fukuoka, , Japan
Local Institution - 607
Kurume, Fukuoka, , Japan
Local Institution - 615
Kyoto, , Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, , Japan
Japanese Red Cross Musashino Hospital
Musashino, , Japan
Local Institution - 602
Musashino, , Japan
Aichi Medical University Hospital
Nagakute, , Japan
Local Institution - 611
Nagakute, , Japan
Local Institution - 603
Osaka-Fu, , Japan
Osaka University Hospital OUH
Osaka-Fu, , Japan
Local Institution - 613
Ōgaki, , Japan
Ogaki Municipal Hospital
Ōgaki, , Japan
Local Institution - 609
Saga, , Japan
Saga University Hospital
Saga, , Japan
Belland General Hospital
Sakaishi, , Japan
Local Institution - 605
Sakaishi, , Japan
Local Institution - 612
Suita, , Japan
Saiseikai Suita Hospital
Suita, , Japan
Local Institution - 600
Yokohama, Kanagawa, , Japan
Yokohama City University Hospital
Yokohama, Kanagawa, , Japan
Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego
Katowice, , Poland
Krakow Medical Center LLC
Krakow, , Poland
Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz, , Poland
Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego
Lodz, , Poland
ID Clinic
Mysłowice, , Poland
Local Institution - 453
Mysłowice, , Poland
Synexus SCM Sp. z o.o. Oddz. Warszawa
Warsaw, , Poland
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Korea University Hospital at Guro
Seoul, , South Korea
Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Hospital Val d'Hebron
Barcelona, , Spain
University Hospital of Girona Dr. Josep Trueta
Girona, , Spain
Parc Tauli Hospital Universitari
Sabadell (Barcelona), , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Virgen del Rocio
Seville, , Spain
University of Birmingham Institute of Biomedical Research
Birmingham, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, , United Kingdom
Local Institution - 558
Hardwick, , United Kingdom
North Tees (DRS) Synexus North Teesside Clinical Research Centre
Hardwick, , United Kingdom
Local Institution - 556
Hexham, , United Kingdom
Synexus Hexham Clinical Research Centre, Hexham (DRS)
Hexham, , United Kingdom
Kings College Hospital
London, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)
London, , United Kingdom
Imperial College University Trust
London, , United Kingdom
Local Institution - 559
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1235-3234
Identifier Type: OTHER
Identifier Source: secondary_id
2018-004431-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-90001-NASH-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.