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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT04048876

Recruitment Status Recruiting

First Posted August 7, 2019

Last update posted December 3, 2020

Study Description

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:Non-alcoholic Fatty Liver Disease
    Liver Cirrhosis
  • Intervention/Treatment: Drug: CC-90001
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: July 2023
Arms and interventions
Arm Intervention/treatment
Experimental: CC-90001 100 mg once daily
CC-90001 100 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 400 mg once daily (QD)
CC-90001 400 mg QD
Drug: CC-90001
oral
Placebo Comparator: Placebo once daily
Placebo QD
Drug: Placebo
oral
Outcome Measures
  • 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
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts

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

Locations
Show 119 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Zoran Popmihajlov, MD Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04048876 History of Changes
  • Other Study ID Numbers: CC-90001-NASH-001, U1111-1235-3234, 2018-004431-79
  • First Posted: August 7, 2019 Key Record Dates
  • Last Update Posted: December 3, 2020
  • Last Verified: December 2020
  • 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/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Non-Alcoholic Fatty Liver
    Liver Fibrosis
    Non-Alcoholic Steatohepatitia
    NASH
    CC-90001
  • Additional relevant MeSH terms: Liver Cirrhosis
    Fibrosis
    Non-alcoholic Fatty Liver Disease
    Fatty Liver
    Liver Diseases