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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048876
Recruitment Status : Terminated (Business objectives have changed)
First Posted : August 7, 2019
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Liver Cirrhosis Drug: CC-90001 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 14, 2019
Actual Primary Completion Date : September 28, 2021
Actual Study Completion Date : September 28, 2021


Arm Intervention/treatment
Experimental: CC-90001 400 mg once daily (QD)
CC-90001 400 mg QD
Drug: CC-90001
oral

Experimental: CC-90001 200 mg once daily
CC-90001 200 mg QD
Drug: CC-90001
oral

Experimental: CC-90001 100 mg once daily
CC-90001 100 mg QD
Drug: CC-90001
oral

Placebo Comparator: Placebo once daily
Placebo QD
Drug: Placebo
oral




Primary Outcome Measures :
  1. Proportion of participants who achieve a ≥1 stage improvement in liver fibrosis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of liver fibrosis score by the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) scoring system


Secondary Outcome Measures :
  1. Proportion of participants who achieve a ≥1 stage improvement in liver fibrosis and no worsening of steatohepatitis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of liver fibrosis score and steatohepatitis

  2. Proportion of participants with an improvement of ≥2 points in the total non-alcoholic fatty liver disease activity score (NAS) score and no worsening of liver fibrosis score [ Time Frame: Up to approximately 52 weeks ]
    Assessment of Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) and liver fibrosis score

  3. Proportion of participants who demonstrate absence of steatohepatitis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of resolution of non-alcoholic steatohepatitis (NASH)

  4. Proportion of participants who progress to cirrhosis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of progression to cirrhosis

  5. Changes from baseline in liver biochemistry [ Time Frame: Up to approximately 52 weeks ]
    Assessment of liver biochemistry (AST, ALT, GGT)

  6. Changes from baseline in metabolic parameters [ Time Frame: Up to approximately 52 weeks ]
    Assessment of metabolic parameters (LDL, HDL, triglycerides)

  7. Dose-related changes in the primary and secondary endpoints [ Time Frame: Up to approximately 52 weeks ]
    Assessment of liver fibrosis score by dose

  8. Adverse Event (AE) [ Time Frame: Up to approximately 106 weeks ]
    Type, frequency, severity, and relationship of adverse events (AEs) to CC-90001

  9. Pharmacokinetics - Cmax [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug plasma concentrationdrug

  10. Pharmacokinetics - AUC [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug plasma concentration

  11. Pharmacokinetics - Tmax [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug plasma concentration

  12. Pharmacokinetics - t1/2 [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug half-life

  13. Pharmacokinetics - CL/F [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug clearance

  14. Pharmacokinetics - Vz/F [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug distribution

  15. Dose-related changes in the primary and secondary endpoints [ Time Frame: Up to approximately 52 weeks ]
    Assessment of non-alcoholic fatty liver disease activity score (NAS) by dose

  16. Proportion of participants who demonstrate absence of steatohepatitis and no worsening of liver fibrosis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of resolution of non-alcoholic steatohepatitis (NASH) and liver fibrosis score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048876


Locations
Show Show 122 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04048876    
Other Study ID Numbers: CC-90001-NASH-001
U1111-1235-3234 ( Other Identifier: WHO )
2018-004431-79 ( EudraCT Number )
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Non-Alcoholic Steatohepatitis
NASH
Non-Alcoholic Fatty Liver
Liver Fibrosis
CC-90001
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Fibrosis
Pathologic Processes
Digestive System Diseases