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Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and Stage 3 or Stage 4 Liver Fibrosis

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ClinicalTrials.gov Identifier: NCT04048876
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
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 (100 mg, 200 mg and 400 mg PO QD), compared with placebo, in NASH subjects with Stage 3 and Stage 4 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)
Estimated Enrollment : 300 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, Adaptive, Dose-Finding Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and F3 or F4 Liver Fibrosis
Estimated Study Start Date : August 7, 2019
Estimated Primary Completion Date : November 16, 2021
Estimated Study Completion Date : May 29, 2023


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 subjects who achieve a ≥1 stage improvement in liver fibrosis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of liver fibrosis score by the NASH Clinical Research Network (CRN) scoring system


Secondary Outcome Measures :
  1. Proportion of subjects 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 subjects with an improvement of ≥2 points in the [ Time Frame: Up to approximately 52 weeks ]
    Assessment of Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) and liver fibrosis score

  3. Proportion of subjects who demonstrate absence of steatohepatitis and no worsening of liver fibrosis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of resolution of NASH

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

  5. Proportion of subjects who achieve the relative reductions in liver stiffness [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging

  6. Percentage change from Baseline in liver stiffness [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging

  7. Proportion of subjects who achieve the relative reductions fat fraction [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging

  8. Percentage change from Baseline in fat fraction [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging

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

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

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

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

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

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

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

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

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

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

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

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



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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 3 or Stage 4 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. Subject 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 (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ with no recurrence in 5 years).
  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


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators
Celgene
Investigators
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Study Director: Zoran Popmihajlov, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04048876     History of Changes
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: August 7, 2019
Last Verified: August 2019
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 Steatohepatitia
NASH
Non-Alcoholic Fatty Liver
Liver Fibrosis
CC-90001

Additional relevant MeSH terms:
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Fibrosis
Liver Diseases
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Digestive System Diseases