Clinical Trial Details

Trial ID: L0123
Source ID: NCT04048876
Associated Drug: CC-90001
Title: Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Acronym: --
Status: Terminated
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Fatty Liver Disease|Liver Cirrhosis
Interventions: Drug: CC-90001|Drug: Placebo
Outcome Measures: Proportion of participants who achieve a ???1 stage improvement in liver fibrosis|Proportion of participants who achieve a ???1 stage improvement in liver fibrosis and no worsening of steatohepatitis|Proportion of participants with an improvement of ???2 points in the total non-alcoholic fatty liver disease activity score (NAS) score and no worsening of liver fibrosis score|Proportion of participants who demonstrate absence of steatohepatitis|Proportion of participants who progress to cirrhosis|Changes from baseline in liver biochemistry|Changes from baseline in metabolic parameters|Dose-related changes in the primary and secondary endpoints|Adverse Event (AE)|Pharmacokinetics - Cmax|Pharmacokinetics - AUC|Pharmacokinetics - Tmax|Pharmacokinetics - t1/2|Pharmacokinetics - CL/F|Pharmacokinetics - Vz/F|Proportion of participants who demonstrate absence of steatohepatitis and no worsening of liver fibrosis
Sponsor/Collaborators: Celgene
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 56
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: August 14, 2019
Completion Date: September 28, 2021
Results First Posted: --
Last Update Posted: October 26, 2021
Locations: 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 Ranch, 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, Saint 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|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 cedex, France|Hopital de la Croix-Rousse, Lyon, France|Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere, Paris CEDEX 13, France|Assistance Publique - Hopitaux de Paris - Hopital Cochin, Paris, France|Hopital Haut Leveque, Pessac Cedex, France|Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou, Rennes cedex 09, France|Hopital Hautepierre, 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, Muenster, Germany|Hamamatsu University Hospital, Hamamatsu, Japan|Nara Medical University Hospital, Kashihara, Japan|Shin-Yurigaoka General Hospital, Kawasaki, Japan|Kurume University Hospital, Kurume, Fukuoka, Japan|University Hospital, Kyoto Prefectural University of Medicine, Kyoto-City, Japan|Japanese Red Cross Musashino Hospital, Musashino, Japan|Aichi Medical University Hospital, Nagakute, Japan|Ogaki Municipal Hospital, Ogaki, Japan|Osaka University Hospital OUH, Osaka-Fu, Japan|Saga University Hospital, Saga, Japan|Belland General Hospital, Sakai-shi, Japan|Saiseikai Suita Hospital, Suita, Japan|Yokohama City University Hospital, Yokohama, Kanagawa, Japan|Soon Chun Hyang University Hospital Bucheon, Bucheon-si, Korea, Republic of|Hanyang University Seoul Hospital, Seoul, Korea, Republic of|Korea University Hospital at Guro, Seoul, Korea, Republic of|Boramae Medical Center, Seoul, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of|Asan Medical Center, Seoul, Korea, Republic of|Yonsei University Wonju Severance Christian Hospital, Wonju-si, Korea, Republic of|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, Myslowice, Poland|Synexus SCM Sp. z o.o. Oddz. Warszawa, Warszawa, Poland|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, Sevilla, Spain|Hospital Virgen del Rocio, Sevilla, Spain|University of Birmingham Institute of Biomedical Research, Birmingham, United Kingdom|Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital, Cambridge, United Kingdom|North Tees (DRS) Synexus North Teesside Clinical Research Centre, Hardwick, 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
URL: https://ClinicalTrials.gov/show/NCT04048876

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D065 CC-90001 Chemical drug -- serine kinase inhibitor -- Under clinical trials Details
D010 Amoxicillin Chemical drug DB01060 -- -- Under clinical trials Details
D223 Metabolic Cofactor Supplementation Supplement -- -- -- Under clinical trials Details