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

NCT04048876 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CC-90001-NASH-001U1111-1235-32342018-004431-79
• Study Type: interventional
• Target: 56
• Locations: 10 countries
• Sites: 142

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.

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Keywords

Non-Alcoholic Steatohepatitis; NASH; Non-Alcoholic Fatty Liver; Liver Fibrosis; CC-90001

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52

  Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) * Stage 0 - None; * Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; * Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; * Stage 1c - Portal/periportal fibrosis only; * Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; * Stage 3 - Bridging fibrosis; * Stage 4 - Cirrhosis.

  From baseline up to week 52

Secondary Outcomes (18)

• Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52

  From baseline up to week 52

• Percentage of Participants With Improvement in Total NAS

  From baseline up to week 52

• Percentage of Participants With Resolution of NASH

  From baseline up to week 52

• Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis

  From baseline up to week 52

• Percentage of Participants Who Progressed to Cirrhosis

  From baseline up to week 52

Study Arms (4)

CC-90001 400 mg once daily (QD)

EXPERIMENTAL

CC-90001 400 mg QD

Drug: CC-90001

CC-90001 200 mg once daily

EXPERIMENTAL

CC-90001 200 mg QD

Drug: CC-90001

CC-90001 100 mg once daily

EXPERIMENTAL

CC-90001 100 mg QD

Drug: CC-90001

Placebo once daily

PLACEBO COMPARATOR

Placebo QD

Drug: Placebo

Interventions

CC-90001 DRUG

oral

CC-90001 100 mg once daily; CC-90001 200 mg once daily; CC-90001 400 mg once daily (QD)

Placebo DRUG

oral

Placebo once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History or evidence of decompensated liver disease,
• Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
• Participant has urine ethyl glucuronide (EtG) \> 500 ng/mL at Screening.
• History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency \[CVID\]).
• History of hepatitis B and/or hepatitis C.
• History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
• Pregnancy or lactation.

Sponsors & Collaborators

• Celgene: lead

Study Sites (142)

Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States

Location

UC San Diego School of Medicine

La Jolla, California, 92093-0960, United States

Location

Cedars-Sinai Comprehensive Transplant Center

Los Angeles, California, 90048, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Southern California GI & Liver Centers

San Clemente, California, 92673, United States

Location

University of Colorado, School of Medicine - Hepatology Clinic - Anschutz

Aurora, Colorado, 80045, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

South Denver Gastroenterology

Englewood, Colorado, 80113, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Florida Digestive Health Specialists

Lakewood Rch, Florida, 34202-2719, United States

Location

Local Institution - 176

Lakewood Rch, Florida, 34202-2719, United States

Location

University of Miami Schiff Center for Liver Diseases

Miami, Florida, 33136, United States

Location

IMIC, Inc.

Palmetto Bay, Florida, 33157, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center - University Cardiovascular Surgeons

Chicago, Illinois, 60612, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

WestGlen Gastrointestinal Consultants, P.A.

Shawnee Mission, Kansas, 66217, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

The Institute for Digestive Health & Liver Disease at Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Digestive Disease Associates, PA

Catonsville, Maryland, 21228, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Saint Louis University School of Medicine

St Louis, Missouri, 63110-0250, United States

Location

University of Nebraska

Omaha, Nebraska, 68198-7680, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Concorde Medical Group

New York, New York, 10016, United States

Location

New York Presbyterian Hospital - Weill-Cornell

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Local Institution - 102

Chapel Hill, North Carolina, 27514, United States

Location

UNC Hospitals GI Medicine Clinic

Chapel Hill, North Carolina, 27514, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Carolinas HealthCare System Digestive Health

Huntersville, North Carolina, 28078, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center - Center for Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

University Gastroenterology

Providence, Rhode Island, 02905, United States

Location

ClinSearch LLC

Chattanooga, Tennessee, 37421, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Texas Clinical Research Institute LLC

Arlington, Texas, 76012, United States

Location

Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Brooke Army Medical Center Francis Street Medical Center

Fort Sam Houston, Texas, 78235-8200, United States

Location

Baylor College of Medicine - Baylor Heart Clinic

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Digestive Health Associates of Texas (DHAT)

Rockwell, Texas, 75032, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Vermont Medical Center Gastro

Burlington, Vermont, 05401, United States

Location

Bon Secours Liver Institute of Hampton Roads

Newport News, Virginia, 23603, United States

Location

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

Bon Secours Liver Institute of Richmond

Richmond, Virginia, 23226, United States

Location

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298-0341, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Liver Institute Northwest PLLC

Seattle, Washington, 98105, United States

Location

University of Sydney - Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2751, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Hospital Brisbane

South Brisbane, Queensland, 4101, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

University of Calgary, Cumming School of Medicine

Calgary, Alberta, T2N 4Z6, Canada

Location

South Edmonton Gastroenterology

Edmonton, Alberta, T6L 6K3, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Toronto Center for Liver Disease - Francis Family Liver Clinic

Toronto, Ontario, M5G 2C4, Canada

Location

CHU d'Angers

Angers, 49033, France

Location

Assistance Publique - Hopitaux de Paris - Hopital Beaujon

Clichy, 92110, France

Location

Hopital de la Croix-Rousse

Lyon, 69317, France

Location

Assistance Publique - Hopitaux de Paris - Hopital Cochin

Paris, 75014, France

Location

Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

Paris, 75651, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou

Rennes, 35033, France

Location

Hopital Hautepierre

Strasbourg, 67098, France

Location

Local Institution - 356

Strasbourg, 67098, France

Location

Universitaetsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, 60590, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Hamamatsu University Hospital

Hamamatsu, 431-3192, Japan

Location

Local Institution - 604

Hamamatsu, 431-3192, Japan

Location

Local Institution - 608

Kashihara, 634-8522, Japan

Location

Nara Medical University Hospital

Kashihara, 634-8522, Japan

Location

Local Institution - 601

Kawasaki, 215-0026, Japan

Location

Shin-Yurigaoka General Hospital

Kawasaki, 215-0026, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Local Institution - 607

Kurume, Fukuoka, 830-0011, Japan

Location

Local Institution - 615

Kyoto, 602-8566, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Japanese Red Cross Musashino Hospital

Musashino, 180-8610, Japan

Location

Local Institution - 602

Musashino, 180-8610, Japan

Location

Aichi Medical University Hospital

Nagakute, 480-1195, Japan

Location

Local Institution - 611

Nagakute, 480-1195, Japan

Location

Local Institution - 603

Osaka-Fu, 565-0871, Japan

Location

Osaka University Hospital OUH

Osaka-Fu, 565-0871, Japan

Location

Local Institution - 613

Ōgaki, 503-8502, Japan

Location

Ogaki Municipal Hospital

Ōgaki, 503-8502, Japan

Location

Local Institution - 609

Saga, 849-8501, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

Belland General Hospital

Sakaishi, 599-8247, Japan

Location

Local Institution - 605

Sakaishi, 599-8247, Japan

Location

Local Institution - 612

Suita, 564-0013, Japan

Location

Saiseikai Suita Hospital

Suita, 564-0013, Japan

Location

Local Institution - 600

Yokohama, Kanagawa, 213-8507, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 213-8507, Japan

Location

Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, 40-040, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego

Katowice, 40-752, Poland

Location

Krakow Medical Center LLC

Krakow, 31-501, Poland

Location

Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi

Lodz, 90-127, Poland

Location

Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego

Lodz, 91-347, Poland

Location

ID Clinic

Mysłowice, 41-400, Poland

Location

Local Institution - 453

Mysłowice, 41-400, Poland

Location

Synexus SCM Sp. z o.o. Oddz. Warszawa

Warsaw, 01-192, Poland

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 420-853, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Korea University Hospital at Guro

Seoul, 152-703, South Korea

Location

Boramae Medical Center

Seoul, 156-707, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Hospital Val d'Hebron

Barcelona, 08035, Spain

Location

University Hospital of Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Parc Tauli Hospital Universitari

Sabadell (Barcelona), 08208, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

University of Birmingham Institute of Biomedical Research

Birmingham, B15 2TT, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Local Institution - 558

Hardwick, TS19 8PE, United Kingdom

Location

North Tees (DRS) Synexus North Teesside Clinical Research Centre

Hardwick, TS19 8PE, United Kingdom

Location

Local Institution - 556

Hexham, NE46 1QJ, United Kingdom

Location

Synexus Hexham Clinical Research Centre, Hexham (DRS)

Hexham, NE46 1QJ, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)

London, SW10 9NH, United Kingdom

Location

Imperial College University Trust

London, W2 1NY, United Kingdom

Location

Local Institution - 559

London, W2 1NY, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Interventions

CC-90001

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: August 7, 2019
• Study Start: August 14, 2019
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: June 7, 2023
• Results First Posted: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (26); KR (7); ES (5); US (64); FR (9); GB (10); CA (4); DE (4); PL (8); AU (5)