A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Study Purpose

This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject understands and has voluntarily signed and dated an informed consent form 2. Subject is male or female ≥ 40 years of age 3. Subject was diagnosed with IPF within 5 years of Screening 4. Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy [SLB] or cryobiopsy) if available according to guidelines. 5. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed. 6. Percent predicted forced vital capacity (% FVC) ≥ 45% and ≤ 95% at Screening 7. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at Screening. 8. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening 9. Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods. 10. Male subjects must practice true abstinence or use a barrier method of contraception. 11. Additional inclusion criteria apply.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subject with a QTcF > 450 msec. 3. Evidence of clinically relevant airways obstruction at Screening. 4. Subjects using any therapy targeted to treat IPF. 5. History of latent or active TB, unless there is medical record documentation of successful completion of a standard course of treatment 6. History of hepatitis B and/or hepatitis C, including those considered successfully treated/cured 7. Pregnancy or lactation. 8. Additional exclusion criteria apply.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03142191

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Celgene

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Zoran Popmihajlov, M.D
Principal Investigator Affiliation Celgene

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Australia, Brazil, Canada, Colombia, Germany, Greece, Romania, Russian Federation, Taiwan, Turkey, Ukraine, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Idiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases
Additional Details

Approximately 135 adult male and female subjects with a confirmed diagnosis of Idiopathic pulmonary fibrosis (IPF) (according to the most recent IPF guideline for diagnosis and management) will be randomized 1:1:1 (45 subjects per arm) to treatment with oral CC-90001 (200 mg QD or 400 mg QD) or matching placebo for an initial 24 weeks. Subjects completing the 24-week Double-blind Treatment Phase will continue onto the blinded 80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to placebo will be re-randomized 1:1 to blinded CC-90001 (200 mg or 400 mg PO QD). During the 80-week Active Treatment Extension Phase, all subjects will have the opportunity, if deemed appropriate by the Investigator, to receive standard of care (SOC). The time to add SOC and the choice of SOC during the Extension Phase will be at the Investigator's discretion. All subjects who complete the study treatment phases and those subjects who discontinue investigational product (IP) prior to the completion of the study will participate in the 4-week Post-treatment Observational Follow-up Phase. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. An external DMC, comprised of independent physician experts and a statistician who are not affiliated with the Sponsor and for whom there is no identified conflict of interest will be responsible for safeguarding study participants' interests and for monitoring the overall conduct of the study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Vermont, Burlington, Vermont

Status

Recruiting

Address

University of Vermont

Burlington, Vermont, 05405

University of Utah Health Care, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health Care

Salt Lake City, Utah, 84132

Baylor University Medical Center, Dallas, Texas

Status

Recruiting

Address

Baylor University Medical Center

Dallas, Texas, 75246

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Pulmonary & Sleep Center of Oklahoma, Tulsa, Oklahoma

Status

Recruiting

Address

Pulmonary & Sleep Center of Oklahoma

Tulsa, Oklahoma, 74137

Cleveland, Ohio

Status

Not yet recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44121

University of Cincinnati Medical Center, Cincinnati, Ohio

Status

Not yet recruiting

Address

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267

Durham, North Carolina

Status

Recruiting

Address

Duke University Health System - Duke Pulmonary Transplant Clinic

Durham, North Carolina, 27710

Mt. Sinai School of Medicine, New York, New York

Status

Recruiting

Address

Mt. Sinai School of Medicine

New York, New York, 10029

The Lung and Research Center, LLC, Chesterfield, Missouri

Status

Recruiting

Address

The Lung and Research Center, LLC

Chesterfield, Missouri, 63017

University of Louisville, Louisville, Kentucky

Status

Recruiting

Address

University of Louisville

Louisville, Kentucky, 40202

Miami, Florida

Status

Recruiting

Address

University of Miami and Sylvester Cancer Center

Miami, Florida, 33136

Stanford, California

Status

Recruiting

Address

Stanford University Pulmonary and Critical Care Clinic

Stanford, California, 94305

Sacramento, California

Status

Recruiting

Address

University of California Davis Health System

Sacramento, California, 95817

Cedars Sinai Medical Center Rheumatology, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center Rheumatology

Los Angeles, California, 90048

International Sites

Southmead Hospital, Westbury-on-Trym/ Bristol, United Kingdom

Status

Recruiting

Address

Southmead Hospital

Westbury-on-Trym/ Bristol, , BS10 5NB

Southampton General Hospital, Southhampton, United Kingdom

Status

Recruiting

Address

Southampton General Hospital

Southhampton, , SO01 6YD

Salford Royal, Salford, United Kingdom

Status

Not yet recruiting

Address

Salford Royal

Salford, , M6 8HD

Nottingham, United Kingdom

Status

Recruiting

Address

The University of Nottingham - Nottingham Respiratory Research Unit NRRU

Nottingham, , NG5 1PB

Norfolk and Norwich University Hospital, Norwich, United Kingdom

Status

Recruiting

Address

Norfolk and Norwich University Hospital

Norwich, , NR4 7UY

Royal Victoria Infirmary, Newcastle, United Kingdom

Status

Recruiting

Address

Royal Victoria Infirmary

Newcastle, , NE1 4LP

University College London Hospitals, London, United Kingdom

Status

Not yet recruiting

Address

University College London Hospitals

London, , NW1 2PG

University Hospital Llandough, Llandough, United Kingdom

Status

Recruiting

Address

University Hospital Llandough

Llandough, , CF64 2XX

Aintree University Hospital, Liverpool (Walton Centre), United Kingdom

Status

Recruiting

Address

Aintree University Hospital

Liverpool (Walton Centre), , L9 7LJ

Leicester, United Kingdom

Status

Recruiting

Address

University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH

Leicester, , LE3 9QP

St James University Hospital, Leeds, United Kingdom

Status

Recruiting

Address

St James University Hospital

Leeds, , LS9 7TF

Hinchingbrooke Hospital, Huntingdon, United Kingdom

Status

Recruiting

Address

Hinchingbrooke Hospital

Huntingdon, , PE29 6NT

Cottingham, United Kingdom

Status

Recruiting

Address

Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

Cottingham, , HU16 5JQ

Birmingham Chest Clinic, Birmingham, United Kingdom

Status

Recruiting

Address

Birmingham Chest Clinic

Birmingham, , B3 3HX

Kyiv, Ukraine

Status

Recruiting

Address

SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences

Kyiv, , 03680

Kyiv, Ukraine

Status

Recruiting

Address

State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine

Kyiv, , 03115

Kharkiv, Ukraine

Status

Recruiting

Address

CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine

Kharkiv, , 61204

Kharkiv City Clinical Hospital #13, Kharkiv, Ukraine

Status

Recruiting

Address

Kharkiv City Clinical Hospital #13

Kharkiv, , 61124

Regional Phthisiopulmonological Center, Ivano-Frankivsk, Ukraine

Status

Recruiting

Address

Regional Phthisiopulmonological Center

Ivano-Frankivsk, , 76018

Dnipro, Ukraine

Status

Recruiting

Address

Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council

Dnipro, , 49023

Izmir, Turkey

Status

Recruiting

Address

Izmir Dr.Suat Seren Chest Diseases Hospital

Izmir, , 35100

Istanbul, Turkey

Status

Recruiting

Address

Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty

Istanbul, , 34098

Uludag Universitesi Tip Fakultesi, Bursa, Turkey

Status

Recruiting

Address

Uludag Universitesi Tip Fakultesi

Bursa, , 16059

Bornova, Turkey

Status

Recruiting

Address

Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital

Bornova, , 35100

National Taiwan University Hospital, Taipei, Zhongzheng Dist., Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei, Zhongzheng Dist., , 100

China Medical University Hospital, Taichung City, Taiwan

Status

Recruiting

Address

China Medical University Hospital

Taichung City, , 40447

Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

Status

Recruiting

Address

Kaohsiung Medical University Hospital

Kaohsiung, , 807

Buddhist Dalin Tzu Chi General Hospital, Dalin, Taiwan

Status

Recruiting

Address

Buddhist Dalin Tzu Chi General Hospital

Dalin, , 62247

Yaroslavl, Russian Federation

Status

Recruiting

Address

SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev

Yaroslavl, , 150003

St. Petersburg, Russian Federation

Status

Recruiting

Address

Saint-Petersburg State Institution of Healthcare

St. Petersburg, , 193312

Vvedenskaya Hospital, St. Petersburg, Russian Federation

Status

Recruiting

Address

Vvedenskaya Hospital

St. Petersburg, , 191180

Saratov Regional Clinical Hospital, Saratov, Russian Federation

Status

Recruiting

Address

Saratov Regional Clinical Hospital

Saratov, , 410053

Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Pavlov First Saint Petersburg State Medical University

Saint-Petersburg, , 197022

Saint Petersburg, Russian Federation

Status

Recruiting

Address

FSBHI Clincial Research Institute of Phithisioplulmonoloyg

Saint Petersburg, , 191036

Republican Hospital, Petrozavodsk, Russian Federation

Status

Not yet recruiting

Address

Republican Hospital

Petrozavodsk, , 185019

Nizhny Novgorod, Russian Federation

Status

Not yet recruiting

Address

Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology

Nizhny Novgorod, , 603011

Moscow, Russian Federation

Status

Recruiting

Address

Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No.

Moscow, ,

Moscow, Russian Federation

Status

Recruiting

Address

Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR

Moscow, , 107564

TSBIH Territorial Clinical Hospital, Krasnoyarsk, Russian Federation

Status

Not yet recruiting

Address

TSBIH Territorial Clinical Hospital

Krasnoyarsk, , 660022

Kemerovo, Russian Federation

Status

Completed

Address

Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul

Kemerovo, , 650002

City clinical hospital No 9, Izhevsk, Russian Federation

Status

Recruiting

Address

City clinical hospital No 9

Izhevsk, , 426063

Ekaterinburg, Russian Federation

Status

Recruiting

Address

Ural State Medical Academy - Medical Association Novaya Bolnitsa

Ekaterinburg, , 620109

Ekaterinburg, Russian Federation

Status

Not yet recruiting

Address

Ural research Institute of Phthisiopulmonology

Ekaterinburg, , 620039

Timisoara, Romania

Status

Terminated

Address

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara

Timisoara, , 300312

Cluj-Napoca, Romania

Status

Terminated

Address

Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca

Cluj-Napoca, ,

Iraklio, Greece

Status

Recruiting

Address

University of Crete - University General Hospital of Heraklion

Iraklio, , 711 10

Heraklion, Greece

Status

Completed

Address

General Hospital of Heraklion Benizeleio Pananeio

Heraklion, , 71409

University General Hospital Attikon, Haidari, Greece

Status

Completed

Address

University General Hospital Attikon

Haidari, , 12462

Alexandroupolis, Greece

Status

Recruiting

Address

University General Hospital of Alexandroupolis

Alexandroupolis, , 68100

Democritus University of Thrace, Alexandroupolis, Greece

Status

Completed

Address

Democritus University of Thrace

Alexandroupolis, , 68100

Wangen Im Allgaeu, Germany

Status

Completed

Address

Waldburg-Zeil Kliniken -Fachkliniken Wangen

Wangen Im Allgaeu, , 88239

Universitatsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitatsklinikum Heidelberg

Heidelberg, , 69120

Greifenstein, Germany

Status

Recruiting

Address

Pneumologische Klinik - Waldhof Elgershausen

Greifenstein, , 35753

Ruhrlandklinik University Hospital, Essen, Germany

Status

Not yet recruiting

Address

Ruhrlandklinik University Hospital

Essen, , 45239

Helios Klinikum Emil Von Behring, Berlin, Germany

Status

Recruiting

Address

Helios Klinikum Emil Von Behring

Berlin, , 14165

Centro Medico Imbanaco, Cali, Colombia

Status

Recruiting

Address

Centro Medico Imbanaco

Cali, ,

Bogotá, Colombia

Status

Recruiting

Address

Centro Especializado en Enfermedades Pulmonares

Bogotá, ,

Windsor, Ontario, Canada

Status

Not yet recruiting

Address

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3

Vancouver, British Columbia, Canada

Status

Recruiting

Address

The Lung Centre Respiratory Clinic - Vancouver General Hospital Location

Vancouver, British Columbia, V5Z 1M9

Kelowna & Respiratory Allergy Clinic, Kelowna, British Columbia, Canada

Status

Recruiting

Address

Kelowna & Respiratory Allergy Clinic

Kelowna, British Columbia, V1W 1V3

Incor - Instituto do Coracao HCFMUSP, Sao Paulo, Brazil

Status

Recruiting

Address

Incor - Instituto do Coracao HCFMUSP

Sao Paulo, , 01414-001

Faculdade de Medicina do ABC, Santo Andre, Brazil

Status

Recruiting

Address

Faculdade de Medicina do ABC

Santo Andre, , 09060-650

Rio de Janeiro, Brazil

Status

Not yet recruiting

Address

Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)

Rio de Janeiro, , 21941

Hospital Ernesto Dornelles, Porto Alegre, Brazil

Status

Not yet recruiting

Address

Hospital Ernesto Dornelles

Porto Alegre, , 90610-093

Hospital Nossa Senhora da Conceicao, Porto Alegre, Rio Grande Do Sul, Brazil

Status

Recruiting

Address

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande Do Sul, 91350-200

Porto Alegre, Rio Grande Do Sul, Brazil

Status

Recruiting

Address

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande Do Sul, 90085-074

Clinica de Pneumologia S/S, Goiania, Goiás, Brazil

Status

Recruiting

Address

Clinica de Pneumologia S/S

Goiania, Goiás, 74110-030

St Vincent Hospital - Sydney, Darlinghurst, Australia

Status

Recruiting

Address

St Vincent Hospital - Sydney

Darlinghurst, , 2010

Institute for Respiratory Health Inc, Nedlands, Western Australia, Australia

Status

Recruiting

Address

Institute for Respiratory Health Inc

Nedlands, Western Australia, 6009

Fiona Stanley Hospital, Murdoch, Western Australia, Australia

Status

Recruiting

Address

Fiona Stanley Hospital

Murdoch, Western Australia, 6150

Royal Melbourne Hospital, Parkville, Victoria, Australia

Status

Recruiting

Address

Royal Melbourne Hospital

Parkville, Victoria, 3050

Flinders Medical Centre, Bedford Park, South Australia, Australia

Status

Recruiting

Address

Flinders Medical Centre

Bedford Park, South Australia, 5042

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Mater Medical Centre, South Brisbane, Queensland, Australia

Status

Recruiting

Address

Mater Medical Centre

South Brisbane, Queensland, 4101

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Status

Recruiting

Address

Concord Repatriation General Hospital

Concord, New South Wales, 2139

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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