Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04048876
Registration number
NCT04048876
Ethics application status
Date submitted
17/07/2019
Date registered
7/08/2019
Date last updated
7/06/2023
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
U1111-1235-3234
Query!
Secondary ID [2]
0
0
CC-90001-NASH-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Fatty Liver Disease
0
0
Query!
Liver Cirrhosis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Cancer
0
0
0
0
Query!
Liver
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Metabolic disorders
Query!
Diet and Nutrition
0
0
0
0
Query!
Obesity
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Connective tissue diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - CC-90001
Treatment: Drugs - Placebo
Experimental: CC-90001 400 mg once daily (QD) - CC-90001 400 mg QD
Experimental: CC-90001 200 mg once daily - CC-90001 200 mg QD
Experimental: CC-90001 100 mg once daily - CC-90001 100 mg QD
Placebo Comparator: Placebo once daily - Placebo QD
Treatment: Drugs: CC-90001
oral
Treatment: Drugs: Placebo
oral
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Who Achieve a =1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From baseline up to week 52
Query!
Secondary outcome [1]
0
0
Percentage of Participants With no Worsening of Steatohepatitis and =1 Stage Improvement in Liver Fibrosis Score at Week 52
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From baseline up to week 52
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Improvement in Total NAS
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From baseline up to week 52
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Resolution of NASH
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From baseline up to week 52
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From baseline up to week 52
Query!
Secondary outcome [5]
0
0
Percentage of Participants Who Progressed to Cirrhosis
Query!
Assessment method [5]
0
0
Percentage of participants who progressed to cirrhosis
Query!
Timepoint [5]
0
0
From baseline up to week 52
Query!
Secondary outcome [6]
0
0
Mean Change From Baseline in Liver Biochemistry
Query!
Assessment method [6]
0
0
Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and ?-glutamyl transferase (GGT)
Query!
Timepoint [6]
0
0
From baseline up to week 52
Query!
Secondary outcome [7]
0
0
Mean Change From Baseline in Metabolic Parameters
Query!
Assessment method [7]
0
0
Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides
Query!
Timepoint [7]
0
0
From baseline up to week 52
Query!
Secondary outcome [8]
0
0
Cmax
Query!
Assessment method [8]
0
0
Cmax is defined as maximum plasma concentration of the drug
Query!
Timepoint [8]
0
0
Day 1 and at Week 4
Query!
Secondary outcome [9]
0
0
Tmax
Query!
Assessment method [9]
0
0
Tmax is defined is the time to maximum plasma concentration
Query!
Timepoint [9]
0
0
Day 1 and at Week 4
Query!
Secondary outcome [10]
0
0
AUC (0-t)
Query!
Assessment method [10]
0
0
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Query!
Timepoint [10]
0
0
Day 1 and at Week 4
Query!
Secondary outcome [11]
0
0
AUC t
Query!
Assessment method [11]
0
0
Area under the plasma concentration time-curve. AUC over the dosing interval.
Query!
Timepoint [11]
0
0
Day 1 and at Week 4
Query!
Secondary outcome [12]
0
0
Apparent Total Body Clearance of the Drug
Query!
Assessment method [12]
0
0
Apparent total body clearance of the drug (CL/F)
Query!
Timepoint [12]
0
0
At Week 4
Query!
Secondary outcome [13]
0
0
Number of Participants With Treatment Related Safety Events
Query!
Assessment method [13]
0
0
Number of participants with treatment related safety events
Query!
Timepoint [13]
0
0
From baseline up to week 52
Query!
Secondary outcome [14]
0
0
Mean Change From Baseline of ECG Results - PR Intervals
Query!
Assessment method [14]
0
0
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)
Query!
Timepoint [14]
0
0
From baseline up to week 52
Query!
Secondary outcome [15]
0
0
Mean Change From Baseline of ECG Results - QRS Duration
Query!
Assessment method [15]
0
0
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)
Query!
Timepoint [15]
0
0
From baseline up to week 52
Query!
Secondary outcome [16]
0
0
Mean Change From Baseline of ECG Results - QT Interval
Query!
Assessment method [16]
0
0
Mean change from baseline in QT interval
QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec
Query!
Timepoint [16]
0
0
From baseline up to week 52
Query!
Secondary outcome [17]
0
0
Mean Change From Baseline of ECG Results - QTcB Interval
Query!
Assessment method [17]
0
0
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/v(RR) RR= Respiration Rate
Query!
Timepoint [17]
0
0
From baseline up to week 52
Query!
Secondary outcome [18]
0
0
Mean Change From Baseline of ECG Results - QTcF Interval
Query!
Assessment method [18]
0
0
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
Query!
Timepoint [18]
0
0
From baseline up to week 52
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/08/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/09/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
56
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
University of Sydney - Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [3]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [4]
0
0
Mater Hospital Brisbane - South Brisbane
Query!
Recruitment hospital [5]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2751 - Kingswood
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Rhode Island
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Tennessee
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Utah
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Vermont
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Virginia
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Washington
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Alberta
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
British Columbia
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Ontario
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Angers
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Clichy cedex
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Lyon
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Paris CEDEX 13
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Paris
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Pessac Cedex
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Rennes cedex 09
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Strasbourg
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Aachen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Frankfurt am Main
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Mainz
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Muenster
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Hamamatsu
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Kashihara
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Kawasaki
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Kurume, Fukuoka
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Kyoto-City
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Musashino
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Nagakute
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Ogaki
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Osaka-Fu
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Saga
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Sakai-shi
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Suita
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Yokohama, Kanagawa
Query!
Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Bucheon-si
Query!
Country [56]
0
0
Korea, Republic of
Query!
State/province [56]
0
0
Seoul
Query!
Country [57]
0
0
Korea, Republic of
Query!
State/province [57]
0
0
Wonju-si
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Katowice
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Krakow
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Lodz
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Myslowice
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Warszawa
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Barcelona
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Girona
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Sabadell (Barcelona)
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Sevilla
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Birmingham
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Cambridge
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Hardwick
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Hexham
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Celgene
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04048876
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04048876
Download to PDF