Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048876
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE August 14, 2019
Estimated Primary Completion Date June 19, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • 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
  • 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
  • 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
  • Proportion of subjects who progress to cirrhosis [ Time Frame: Up to approximately 52 weeks ]
    Assessment of progression to cirrhosis
  • Proportion of subjects who achieve the relative reductions in liver stiffness [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging
  • Percentage change from Baseline in liver stiffness [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging
  • Proportion of subjects who achieve the relative reductions fat fraction [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging
  • Percentage change from Baseline in fat fraction [ Time Frame: At week 24 and week 52 ]
    Assessment by imaging
  • Changes from baseline in liver biochemistry [ Time Frame: Up to approximately 52 weeks ]
    Assessment of liver biochemistry (AST, ALT, GGT)
  • Changes from baseline in metabolic parameters [ Time Frame: Up to approximately 52 weeks ]
    Assessment of metabolic parameters (LDL, HDL, triglycerides)
  • Dose-related changes in the primary and secondary endpoints [ Time Frame: Up to approximately 52 weeks ]
    Assessment of liver fibrosis score by dose
  • Adverse Event (AE) [ Time Frame: Up to approximately 106 weeks ]
    Type, frequency, severity, and relationship of adverse events (AEs) to CC-90001
  • Pharmacokinetics - Cmax [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug plasma concentrationdrug
  • Pharmacokinetics - AUC [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug plasma concentration
  • Pharmacokinetics - Tmax [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug plasma concentration
  • Pharmacokinetics - t1/2 [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug half-life
  • Pharmacokinetics - CL/F [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug clearance
  • Pharmacokinetics - Vz/F [ Time Frame: At Day 1 and Week 4 ]
    Assessment of drug distribution
  • Dose-related changes in the primary and secondary endpoints [ Time Frame: Up to approximately 52 weeks ]
    Assessment of NAS by dose
  • Dose-related changes in the primary and secondary endpoints [ Time Frame: Up to approximately 52 weeks ]
    Assessment of imaging by dose
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Official Title  ICMJE 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
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 2, Stage 3 or 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-alcoholic Fatty Liver Disease
  • Liver Cirrhosis
Intervention  ICMJE
  • Drug: CC-90001
    oral
  • Drug: Placebo
    oral
Study Arms  ICMJE
  • Experimental: CC-90001 400 mg once daily (QD)
    CC-90001 400 mg QD
    Intervention: Drug: CC-90001
  • Experimental: CC-90001 200 mg once daily
    CC-90001 200 mg QD
    Intervention: Drug: CC-90001
  • Experimental: CC-90001 100 mg once daily
    CC-90001 100 mg QD
    Intervention: Drug: CC-90001
  • Placebo Comparator: Placebo once daily
    Placebo QD
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 4, 2024
Estimated Primary Completion Date June 19, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 2, 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 within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
  7. Pregnancy or lactation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Japan,   Korea, Republic of,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04048876
Other Study ID Numbers  ICMJE CC-90001-NASH-001
U1111-1235-3234 ( Other Identifier: WHO )
2018-004431-79 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zoran Popmihajlov, MD Celgene
PRS Account Celgene
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP