Clinical trial NCT04048876: Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Keywords: Non-Alcoholic Steatohepatitis
NASH
Non-Alcoholic Fatty Liver
Liver Fibrosis
CC-90001
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-08-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.

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.


Eligibility criteria: Inclusion Criteria:

* Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 2, Stage 3 fibrosis based of the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher

Exclusion Criteria:

- Key Exclusion Criteria

1. History or evidence of decompensated liver disease,
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.

Primary outcomes:
measure: Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52
timeFrame: From baseline up to week 52
Secondary outcomes:
measure: Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52
timeFrame: From baseline up to week 52
measure: Percentage of Participants With Improvement in Total NAS
timeFrame: From baseline up to week 52
measure: Percentage of Participants With Resolution of NASH
timeFrame: From baseline up to week 52
measure: Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis
timeFrame: From baseline up to week 52
measure: Percentage of Participants Who Progressed to Cirrhosis
timeFrame: From baseline up to week 52
measure: Mean Change From Baseline in Liver Biochemistry
timeFrame: From baseline up to week 52
measure: Mean Change From Baseline in Metabolic Parameters
timeFrame: From baseline up to week 52
measure: Cmax
timeFrame: Day 1 and at Week 4
measure: Tmax
timeFrame: Day 1 and at Week 4
measure: AUC (0-t)
timeFrame: Day 1 and at Week 4
measure: AUC t
timeFrame: Day 1 and at Week 4
measure: Apparent Total Body Clearance of the Drug
timeFrame: At Week 4
measure: Number of Participants With Treatment Related Safety Events
timeFrame: From baseline up to week 52
measure: Mean Change From Baseline of ECG Results - PR Intervals
timeFrame: From baseline up to week 52
measure: Mean Change From Baseline of ECG Results - QRS Duration
timeFrame: From baseline up to week 52
measure: Mean Change From Baseline of ECG Results - QT Interval
timeFrame: From baseline up to week 52
measure: Mean Change From Baseline of ECG Results - QTcB Interval
timeFrame: From baseline up to week 52
measure: Mean Change From Baseline of ECG Results - QTcF Interval
timeFrame: From baseline up to week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Phoenix
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego School of Medicine
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Comprehensive Transplant Center
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Clemente
country: United States
facility: Southern California GI & Liver Centers
state: California
city: Aurora
country: United States
facility: University of Colorado, School of Medicine - Hepatology Clinic - Anschutz
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Lakewood Ranch
country: United States
facility: Florida Digestive Health Specialists
state: Florida
city: Lakewood Ranch
country: United States
facility: Local Institution - 176
state: Florida
city: Miami
country: United States
facility: University of Miami Schiff Center for Liver Diseases
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc.
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center - University Cardiovascular Surgeons
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Shawnee Mission
country: United States
facility: WestGlen Gastrointestinal Consultants, P.A.
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: The Institute for Digestive Health & Liver Disease at Mercy Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill-Cornell
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 102
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals GI Medicine Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Huntersville
country: United States
facility: Carolinas HealthCare System Digestive Health
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Center for Liver Diseases
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Chattanooga
country: United States
facility: ClinSearch LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute LLC
state: Texas
city: Dallas
country: United States
facility: Liver Institute at Methodist Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center Francis Street Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Heart Clinic
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Rockwell
country: United States
facility: Digestive Health Associates of Texas (DHAT)
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center Gastro
state: Vermont
city: Newport News
country: United States
facility: Bon Secours Liver Institute of Hampton Roads
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Richmond
state: Virginia
city: Richmond
country: United States
facility: McGuire Veterans Affairs Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Medicine
state: Virginia
city: Seattle
country: United States
facility: University of Washington Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Liver Institute Northwest PLLC
state: Washington
city: Camperdown
country: Australia
facility: University of Sydney - Royal Prince Alfred Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Calgary
country: Canada
facility: University of Calgary, Cumming School of Medicine
state: Alberta
city: Edmonton
country: Canada
facility: South Edmonton Gastroenterology
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Center for Liver Disease - Francis Family Liver Clinic
state: Ontario
city: Angers
country: France
facility: CHU d'Angers
city: Clichy cedex
country: France
facility: Assistance Publique - Hopitaux de Paris - Hopital Beaujon
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
city: Paris CEDEX 13
country: France
facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris - Hopital Cochin
city: Pessac Cedex
country: France
facility: Hopital Haut Leveque
city: Rennes cedex 09
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou
city: Strasbourg
country: France
facility: Hopital Hautepierre
city: Strasbourg
country: France
facility: Local Institution - 356
city: Aachen
country: Germany
facility: Universitaetsklinikum der RWTH Aachen
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe University Hospital
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Hamamatsu
country: Japan
facility: Local Institution - 604
city: Kashihara
country: Japan
facility: Local Institution - 608
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kawasaki
country: Japan
facility: Local Institution - 601
city: Kawasaki
country: Japan
facility: Shin-Yurigaoka General Hospital
city: Kurume, Fukuoka
country: Japan
facility: Kurume University Hospital
city: Kurume, Fukuoka
country: Japan
facility: Local Institution - 607
city: Kyoto-City
country: Japan
facility: Local Institution - 615
city: Kyoto-City
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Musashino
country: Japan
facility: Japanese Red Cross Musashino Hospital
city: Musashino
country: Japan
facility: Local Institution - 602
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nagakute
country: Japan
facility: Local Institution - 611
city: Ogaki
country: Japan
facility: Local Institution - 613
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Osaka-Fu
country: Japan
facility: Local Institution - 603
city: Osaka-Fu
country: Japan
facility: Osaka University Hospital OUH
city: Saga
country: Japan
facility: Local Institution - 609
city: Saga
country: Japan
facility: Saga University Hospital
city: Sakai-shi
country: Japan
facility: Belland General Hospital
city: Sakai-shi
country: Japan
facility: Local Institution - 605
city: Suita
country: Japan
facility: Local Institution - 612
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
city: Yokohama, Kanagawa
country: Japan
facility: Local Institution - 600
city: Yokohama, Kanagawa
country: Japan
facility: Yokohama City University Hospital
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Hospital at Guro
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Katowice
country: Poland
facility: Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Katowice
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego
city: Krakow
country: Poland
facility: Krakow Medical Center LLC
city: Lodz
country: Poland
facility: Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego
city: Myslowice
country: Poland
facility: ID Clinic
city: Myslowice
country: Poland
facility: Local Institution - 453
city: Warszawa
country: Poland
facility: Synexus SCM Sp. z o.o. Oddz. Warszawa
city: Barcelona
country: Spain
facility: Hospital Val d'Hebron
city: Girona
country: Spain
facility: University Hospital of Girona Dr. Josep Trueta
city: Sabadell (Barcelona)
country: Spain
facility: Parc Tauli Hospital Universitari
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Birmingham
country: United Kingdom
facility: University of Birmingham Institute of Biomedical Research
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
city: Hardwick
country: United Kingdom
facility: Local Institution - 558
city: Hardwick
country: United Kingdom
facility: North Tees (DRS) Synexus North Teesside Clinical Research Centre
city: Hexham
country: United Kingdom
facility: Local Institution - 556
city: Hexham
country: United Kingdom
facility: Synexus Hexham Clinical Research Centre, Hexham (DRS)
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)
city: London
country: United Kingdom
facility: Imperial College University Trust
city: London
country: United Kingdom
facility: Local Institution - 559
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: