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Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

Primary Purpose

Non-alcoholic Fatty Liver Disease, Liver Cirrhosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-90001
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Non-Alcoholic Steatohepatitis, NASH, Non-Alcoholic Fatty Liver, Liver Fibrosis, CC-90001

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute
  • Mayo Clinic Phoenix
  • UC San Diego School of Medicine
  • Cedars-Sinai Comprehensive Transplant Center
  • California Liver Research Institute
  • Inland Empire Liver Foundation
  • University of California Davis Medical Center
  • Southern California GI & Liver Centers
  • University of Colorado, School of Medicine - Hepatology Clinic - Anschutz
  • Peak Gastroenterology Associates
  • South Denver Gastroenterology
  • Bridgeport Hospital
  • Yale Cancer Center
  • Florida Digestive Health Specialists
  • Local Institution - 176
  • University of Miami Schiff Center for Liver Diseases
  • IMIC, Inc.
  • Advanced Medical Research Center
  • Tampa General Hospital
  • Gastrointestinal Specialists of Georgia, PC
  • Rush University Medical Center - University Cardiovascular Surgeons
  • University of Chicago Medicine
  • WestGlen Gastrointestinal Consultants, P.A.
  • Tulane University Health Sciences Center
  • Ochsner Medical Center
  • The Institute for Digestive Health & Liver Disease at Mercy Medical Center
  • Digestive Disease Associates, PA
  • Boston University Medical Center
  • Beth Israel Deaconness Medical Center
  • University of Michigan
  • Henry Ford Hospital
  • University of Mississippi Medical Center
  • Saint Louis University School of Medicine
  • University of Nebraska
  • Beth Israel Medical Center
  • Concorde Medical Group
  • New York Presbyterian Hospital - Weill-Cornell
  • University of Rochester Medical Center
  • Local Institution - 102
  • UNC Hospitals GI Medicine Clinic
  • Duke University School of Medicine
  • Carolinas HealthCare System Digestive Health
  • Ohio State University Wexner Medical Center
  • University of Pittsburgh Medical Center - Center for Liver Diseases
  • University Gastroenterology
  • ClinSearch LLC
  • Gastro One
  • Texas Clinical Research Institute LLC
  • Liver Institute at Methodist Dallas
  • UT Southwestern Medical Center
  • Brooke Army Medical Center Francis Street Medical Center
  • Baylor College of Medicine - Baylor Heart Clinic
  • Houston Methodist Hospital
  • Digestive Health Associates of Texas (DHAT)
  • American Research Corporation
  • Intermountain Medical Center
  • University of Vermont Medical Center Gastro
  • Bon Secours Liver Institute of Hampton Roads
  • Digestive and Liver Disease Specialists
  • Bon Secours Liver Institute of Richmond
  • McGuire Veterans Affairs Medical Center
  • Virginia Commonwealth University School of Medicine
  • University of Washington Harborview Medical Center
  • Liver Institute Northwest PLLC
  • University of Sydney - Royal Prince Alfred Hospital
  • Nepean Hospital
  • Royal Brisbane and Women's Hospital
  • Mater Hospital Brisbane
  • The Alfred Hospital
  • University of Calgary, Cumming School of Medicine
  • South Edmonton Gastroenterology
  • Vancouver General Hospital
  • Toronto Center for Liver Disease - Francis Family Liver Clinic
  • CHU d'Angers
  • Assistance Publique - Hopitaux de Paris - Hopital Beaujon
  • Hopital de la Croix-Rousse
  • Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
  • Assistance Publique - Hopitaux de Paris - Hopital Cochin
  • Hopital Haut Leveque
  • Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou
  • Hopital Hautepierre
  • Local Institution - 356
  • Universitaetsklinikum der RWTH Aachen
  • Johann Wolfgang Goethe University Hospital
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Universitaetsklinikum Muenster
  • Hamamatsu University Hospital
  • Local Institution - 604
  • Local Institution - 608
  • Nara Medical University Hospital
  • Local Institution - 601
  • Shin-Yurigaoka General Hospital
  • Kurume University Hospital
  • Local Institution - 607
  • Local Institution - 615
  • University Hospital, Kyoto Prefectural University of Medicine
  • Japanese Red Cross Musashino Hospital
  • Local Institution - 602
  • Aichi Medical University Hospital
  • Local Institution - 611
  • Local Institution - 613
  • Ogaki Municipal Hospital
  • Local Institution - 603
  • Osaka University Hospital OUH
  • Local Institution - 609
  • Saga University Hospital
  • Belland General Hospital
  • Local Institution - 605
  • Local Institution - 612
  • Saiseikai Suita Hospital
  • Local Institution - 600
  • Yokohama City University Hospital
  • Soon Chun Hyang University Hospital Bucheon
  • Hanyang University Seoul Hospital
  • Korea University Hospital at Guro
  • Boramae Medical Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Yonsei University Wonju Severance Christian Hospital
  • Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego
  • Krakow Medical Center LLC
  • Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi
  • Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego
  • ID Clinic
  • Local Institution - 453
  • Synexus SCM Sp. z o.o. Oddz. Warszawa
  • Hospital Val d'Hebron
  • University Hospital of Girona Dr. Josep Trueta
  • Parc Tauli Hospital Universitari
  • Hospital Universitario Virgen Macarena
  • Hospital Virgen del Rocio
  • University of Birmingham Institute of Biomedical Research
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
  • Local Institution - 558
  • North Tees (DRS) Synexus North Teesside Clinical Research Centre
  • Local Institution - 556
  • Synexus Hexham Clinical Research Centre, Hexham (DRS)
  • Kings College Hospital
  • Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)
  • Imperial College University Trust
  • Local Institution - 559

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CC-90001 400 mg once daily (QD)

CC-90001 200 mg once daily

CC-90001 100 mg once daily

Placebo once daily

Arm Description

CC-90001 400 mg QD

CC-90001 200 mg QD

CC-90001 100 mg QD

Placebo QD

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52
Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) Stage 0 - None; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; Stage 1c - Portal/periportal fibrosis only; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; Stage 3 - Bridging fibrosis; Stage 4 - Cirrhosis.

Secondary Outcome Measures

Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52
Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) Stage 0 - None; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; Stage 1c - Portal/periportal fibrosis only; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; Stage 3 - Bridging fibrosis; Stage 4 - Cirrhosis.
Percentage of Participants With Improvement in Total NAS
Percentage of participants with an improvement of ≥ 2 points in the total NAS with improvement in more than one category of steatosis, lobular inflammation, and hepatocellular ballooning, and no worsening of liver fibrosis at Week 52. A participant with a change of ≤ -2 from baseline in total NAS, a change of ≤ -1 from baseline in more than one subscore, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Percentage of Participants With Resolution of NASH
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 at Week 52. Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation is considered as a responder for this endpoint.
Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 and no worsening of liver fibrosis at Week 52 Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Percentage of Participants Who Progressed to Cirrhosis
Percentage of participants who progressed to cirrhosis
Mean Change From Baseline in Liver Biochemistry
Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT)
Mean Change From Baseline in Metabolic Parameters
Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides
Cmax
Cmax is defined as maximum plasma concentration of the drug
Tmax
Tmax is defined is the time to maximum plasma concentration
AUC (0-t)
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
AUC t
Area under the plasma concentration time-curve. AUC over the dosing interval.
Apparent Total Body Clearance of the Drug
Apparent total body clearance of the drug (CL/F)
Number of Participants With Treatment Related Safety Events
Number of participants with treatment related safety events
Mean Change From Baseline of ECG Results - PR Intervals
Mean change from baseline in PR interval PR Interval: Atrial depolarization and conduction through the AV node Normal Range: 0.12 - 0.20 (120 to 200 msec)
Mean Change From Baseline of ECG Results - QRS Duration
Mean change from baseline in QRS duration QRS Duration: Ventricular depolarization and atrial repolarization Normal Range: 0.08 to 0.10 (80 to 100 msec)
Mean Change From Baseline of ECG Results - QT Interval
Mean change from baseline in QT interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec
Mean Change From Baseline of ECG Results - QTcB Interval
Mean change from baseline in QTcB interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula. QTc = QT/√(RR) RR= Respiration Rate
Mean Change From Baseline of ECG Results - QTcF Interval
Mean change from baseline in QTcF interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate

Full Information

First Posted
July 17, 2019
Last Updated
June 6, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT04048876
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Business objectives have changed
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
Keywords
Non-Alcoholic Steatohepatitis, NASH, Non-Alcoholic Fatty Liver, Liver Fibrosis, CC-90001

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CC-90001 400 mg once daily (QD)
Arm Type
Experimental
Arm Description
CC-90001 400 mg QD
Arm Title
CC-90001 200 mg once daily
Arm Type
Experimental
Arm Description
CC-90001 200 mg QD
Arm Title
CC-90001 100 mg once daily
Arm Type
Experimental
Arm Description
CC-90001 100 mg QD
Arm Title
Placebo once daily
Arm Type
Placebo Comparator
Arm Description
Placebo QD
Intervention Type
Drug
Intervention Name(s)
CC-90001
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52
Description
Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) Stage 0 - None; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; Stage 1c - Portal/periportal fibrosis only; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; Stage 3 - Bridging fibrosis; Stage 4 - Cirrhosis.
Time Frame
From baseline up to week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52
Description
Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) Stage 0 - None; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; Stage 1c - Portal/periportal fibrosis only; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; Stage 3 - Bridging fibrosis; Stage 4 - Cirrhosis.
Time Frame
From baseline up to week 52
Title
Percentage of Participants With Improvement in Total NAS
Description
Percentage of participants with an improvement of ≥ 2 points in the total NAS with improvement in more than one category of steatosis, lobular inflammation, and hepatocellular ballooning, and no worsening of liver fibrosis at Week 52. A participant with a change of ≤ -2 from baseline in total NAS, a change of ≤ -1 from baseline in more than one subscore, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Time Frame
From baseline up to week 52
Title
Percentage of Participants With Resolution of NASH
Description
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 at Week 52. Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation is considered as a responder for this endpoint.
Time Frame
From baseline up to week 52
Title
Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis
Description
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 and no worsening of liver fibrosis at Week 52 Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Time Frame
From baseline up to week 52
Title
Percentage of Participants Who Progressed to Cirrhosis
Description
Percentage of participants who progressed to cirrhosis
Time Frame
From baseline up to week 52
Title
Mean Change From Baseline in Liver Biochemistry
Description
Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT)
Time Frame
From baseline up to week 52
Title
Mean Change From Baseline in Metabolic Parameters
Description
Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides
Time Frame
From baseline up to week 52
Title
Cmax
Description
Cmax is defined as maximum plasma concentration of the drug
Time Frame
Day 1 and at Week 4
Title
Tmax
Description
Tmax is defined is the time to maximum plasma concentration
Time Frame
Day 1 and at Week 4
Title
AUC (0-t)
Description
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Time Frame
Day 1 and at Week 4
Title
AUC t
Description
Area under the plasma concentration time-curve. AUC over the dosing interval.
Time Frame
Day 1 and at Week 4
Title
Apparent Total Body Clearance of the Drug
Description
Apparent total body clearance of the drug (CL/F)
Time Frame
At Week 4
Title
Number of Participants With Treatment Related Safety Events
Description
Number of participants with treatment related safety events
Time Frame
From baseline up to week 52
Title
Mean Change From Baseline of ECG Results - PR Intervals
Description
Mean change from baseline in PR interval PR Interval: Atrial depolarization and conduction through the AV node Normal Range: 0.12 - 0.20 (120 to 200 msec)
Time Frame
From baseline up to week 52
Title
Mean Change From Baseline of ECG Results - QRS Duration
Description
Mean change from baseline in QRS duration QRS Duration: Ventricular depolarization and atrial repolarization Normal Range: 0.08 to 0.10 (80 to 100 msec)
Time Frame
From baseline up to week 52
Title
Mean Change From Baseline of ECG Results - QT Interval
Description
Mean change from baseline in QT interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec
Time Frame
From baseline up to week 52
Title
Mean Change From Baseline of ECG Results - QTcB Interval
Description
Mean change from baseline in QTcB interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula. QTc = QT/√(RR) RR= Respiration Rate
Time Frame
From baseline up to week 52
Title
Mean Change From Baseline of ECG Results - QTcF Interval
Description
Mean change from baseline in QTcF interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate
Time Frame
From baseline up to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 History or evidence of decompensated liver disease, Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH). Participant has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening. 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]). History of hepatitis B and/or hepatitis C. History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ). Pregnancy or lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
UC San Diego School of Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0960
Country
United States
Facility Name
Cedars-Sinai Comprehensive Transplant Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Southern California GI & Liver Centers
City
San Clemente
State/Province
California
ZIP/Postal Code
92673
Country
United States
Facility Name
University of Colorado, School of Medicine - Hepatology Clinic - Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Florida Digestive Health Specialists
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34202-2719
Country
United States
Facility Name
Local Institution - 176
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34202-2719
Country
United States
Facility Name
University of Miami Schiff Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
IMIC, Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical Center - University Cardiovascular Surgeons
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
WestGlen Gastrointestinal Consultants, P.A.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66217
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
The Institute for Digestive Health & Liver Disease at Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Digestive Disease Associates, PA
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Louis University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Presbyterian Hospital - Weill-Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Local Institution - 102
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Hospitals GI Medicine Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolinas HealthCare System Digestive Health
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh Medical Center - Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
ClinSearch LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Clinical Research Institute LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Liver Institute at Methodist Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Brooke Army Medical Center Francis Street Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78235-8200
Country
United States
Facility Name
Baylor College of Medicine - Baylor Heart Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Digestive Health Associates of Texas (DHAT)
City
Rockwell
State/Province
Texas
ZIP/Postal Code
75032
Country
United States
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Vermont Medical Center Gastro
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Bon Secours Liver Institute of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23603
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bon Secours Liver Institute of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Commonwealth University School of Medicine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0341
Country
United States
Facility Name
University of Washington Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Liver Institute Northwest PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University of Sydney - Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
University of Calgary, Cumming School of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
South Edmonton Gastroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6K3
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Toronto Center for Liver Disease - Francis Family Liver Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Assistance Publique - Hopitaux de Paris - Hopital Beaujon
City
Clichy cedex
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere
City
Paris CEDEX 13
ZIP/Postal Code
75651
Country
France
Facility Name
Assistance Publique - Hopitaux de Paris - Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou
City
Rennes cedex 09
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Local Institution - 356
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Universitaetsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Johann Wolfgang Goethe University Hospital
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Local Institution - 604
City
Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Local Institution - 608
City
Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Local Institution - 601
City
Kawasaki
ZIP/Postal Code
215-0026
Country
Japan
Facility Name
Shin-Yurigaoka General Hospital
City
Kawasaki
ZIP/Postal Code
215-0026
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume, Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Local Institution - 607
City
Kurume, Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Local Institution - 615
City
Kyoto-City
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto-City
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Japanese Red Cross Musashino Hospital
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Local Institution - 602
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Nagakute
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Local Institution - 611
City
Nagakute
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Local Institution - 613
City
Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Local Institution - 603
City
Osaka-Fu
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka University Hospital OUH
City
Osaka-Fu
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Local Institution - 609
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Belland General Hospital
City
Sakai-shi
ZIP/Postal Code
599-8247
Country
Japan
Facility Name
Local Institution - 605
City
Sakai-shi
ZIP/Postal Code
599-8247
Country
Japan
Facility Name
Local Institution - 612
City
Suita
ZIP/Postal Code
564-0013
Country
Japan
Facility Name
Saiseikai Suita Hospital
City
Suita
ZIP/Postal Code
564-0013
Country
Japan
Facility Name
Local Institution - 600
City
Yokohama, Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama, Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon-si
ZIP/Postal Code
420-853
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Korea University Hospital at Guro
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-si
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Krakow Medical Center LLC
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi
City
Lodz
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
ID Clinic
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Local Institution - 453
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Synexus SCM Sp. z o.o. Oddz. Warszawa
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Hospital Val d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
University Hospital of Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Parc Tauli Hospital Universitari
City
Sabadell (Barcelona)
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
University of Birmingham Institute of Biomedical Research
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Local Institution - 558
City
Hardwick
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
North Tees (DRS) Synexus North Teesside Clinical Research Centre
City
Hardwick
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
Local Institution - 556
City
Hexham
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Synexus Hexham Clinical Research Centre, Hexham (DRS)
City
Hexham
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Imperial College University Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Local Institution - 559
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

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