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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04048876




Registration number
NCT04048876
Ethics application status
Date submitted
17/07/2019
Date registered
7/08/2019

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
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
Secondary ID [1] 0 0
U1111-1235-3234
Secondary ID [2] 0 0
CC-90001-NASH-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Fatty Liver Disease 0 0
Liver Cirrhosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
From baseline up to week 52
Secondary outcome [1] 0 0
Percentage of Participants With no Worsening of Steatohepatitis and =1 Stage Improvement in Liver Fibrosis Score at Week 52
Timepoint [1] 0 0
From baseline up to week 52
Secondary outcome [2] 0 0
Percentage of Participants With Improvement in Total NAS
Timepoint [2] 0 0
From baseline up to week 52
Secondary outcome [3] 0 0
Percentage of Participants With Resolution of NASH
Timepoint [3] 0 0
From baseline up to week 52
Secondary outcome [4] 0 0
Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis
Timepoint [4] 0 0
From baseline up to week 52
Secondary outcome [5] 0 0
Percentage of Participants Who Progressed to Cirrhosis
Timepoint [5] 0 0
From baseline up to week 52
Secondary outcome [6] 0 0
Mean Change From Baseline in Liver Biochemistry
Timepoint [6] 0 0
From baseline up to week 52
Secondary outcome [7] 0 0
Mean Change From Baseline in Metabolic Parameters
Timepoint [7] 0 0
From baseline up to week 52
Secondary outcome [8] 0 0
Cmax
Timepoint [8] 0 0
Day 1 and at Week 4
Secondary outcome [9] 0 0
Tmax
Timepoint [9] 0 0
Day 1 and at Week 4
Secondary outcome [10] 0 0
AUC (0-t)
Timepoint [10] 0 0
Day 1 and at Week 4
Secondary outcome [11] 0 0
AUC t
Timepoint [11] 0 0
Day 1 and at Week 4
Secondary outcome [12] 0 0
Apparent Total Body Clearance of the Drug
Timepoint [12] 0 0
At Week 4
Secondary outcome [13] 0 0
Number of Participants With Treatment Related Safety Events
Timepoint [13] 0 0
From baseline up to week 52
Secondary outcome [14] 0 0
Mean Change From Baseline of ECG Results - PR Intervals
Timepoint [14] 0 0
From baseline up to week 52
Secondary outcome [15] 0 0
Mean Change From Baseline of ECG Results - QRS Duration
Timepoint [15] 0 0
From baseline up to week 52
Secondary outcome [16] 0 0
Mean Change From Baseline of ECG Results - QT Interval
Timepoint [16] 0 0
From baseline up to week 52
Secondary outcome [17] 0 0
Mean Change From Baseline of ECG Results - QTcB Interval
Timepoint [17] 0 0
From baseline up to week 52
Secondary outcome [18] 0 0
Mean Change From Baseline of ECG Results - QTcF Interval
Timepoint [18] 0 0
From baseline up to week 52

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2021
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
University of Sydney - Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2751 - Kingswood
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Vermont
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
France
State/province [30] 0 0
Angers
Country [31] 0 0
France
State/province [31] 0 0
Clichy cedex
Country [32] 0 0
France
State/province [32] 0 0
Lyon
Country [33] 0 0
France
State/province [33] 0 0
Paris CEDEX 13
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Pessac Cedex
Country [36] 0 0
France
State/province [36] 0 0
Rennes cedex 09
Country [37] 0 0
France
State/province [37] 0 0
Strasbourg
Country [38] 0 0
Germany
State/province [38] 0 0
Aachen
Country [39] 0 0
Germany
State/province [39] 0 0
Frankfurt am Main
Country [40] 0 0
Germany
State/province [40] 0 0
Mainz
Country [41] 0 0
Germany
State/province [41] 0 0
Muenster
Country [42] 0 0
Japan
State/province [42] 0 0
Hamamatsu
Country [43] 0 0
Japan
State/province [43] 0 0
Kashihara
Country [44] 0 0
Japan
State/province [44] 0 0
Kawasaki
Country [45] 0 0
Japan
State/province [45] 0 0
Kurume, Fukuoka
Country [46] 0 0
Japan
State/province [46] 0 0
Kyoto-City
Country [47] 0 0
Japan
State/province [47] 0 0
Musashino
Country [48] 0 0
Japan
State/province [48] 0 0
Nagakute
Country [49] 0 0
Japan
State/province [49] 0 0
Ogaki
Country [50] 0 0
Japan
State/province [50] 0 0
Osaka-Fu
Country [51] 0 0
Japan
State/province [51] 0 0
Saga
Country [52] 0 0
Japan
State/province [52] 0 0
Sakai-shi
Country [53] 0 0
Japan
State/province [53] 0 0
Suita
Country [54] 0 0
Japan
State/province [54] 0 0
Yokohama, Kanagawa
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Bucheon-si
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Wonju-si
Country [58] 0 0
Poland
State/province [58] 0 0
Katowice
Country [59] 0 0
Poland
State/province [59] 0 0
Krakow
Country [60] 0 0
Poland
State/province [60] 0 0
Lodz
Country [61] 0 0
Poland
State/province [61] 0 0
Myslowice
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Girona
Country [65] 0 0
Spain
State/province [65] 0 0
Sabadell (Barcelona)
Country [66] 0 0
Spain
State/province [66] 0 0
Sevilla
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Birmingham
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Cambridge
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Hardwick
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Hexham
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04048876