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

Celgene

Status and phase: Terminated; Phase 2

Conditions: Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Treatments: Drug: CC-90001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04048876

CC-90001-NASH-001

2018-004431-79 (EudraCT Number)

U1111-1235-3234 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 4 patient groups, including a placebo group

CC-90001 400 mg once daily (QD)

Experimental group

Description:

CC-90001 400 mg QD

Treatment:

Drug: CC-90001

CC-90001 200 mg once daily

Experimental group

Description:

CC-90001 200 mg QD

Treatment:

Drug: CC-90001

CC-90001 100 mg once daily

Experimental group

Description:

CC-90001 100 mg QD

Treatment:

Drug: CC-90001

Placebo once daily

Placebo Comparator group

Description:

Placebo QD

Treatment:

Drug: Placebo