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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
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
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. |
Interventional |
Eligible Ages | 40 Years and Over |
Gender | All |
Inclusion Criteria:
Subject understands and has voluntarily signed and dated an informed consent form. 1. Subject is male or female ā„ 40 years of age. 2. Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy [SLB] or cryobiopsy) if available according to guidelines. 3. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed. 4. Percent predicted forced vital capacity (% FVC) ā„ 45% and ā¤ 95% at Screening. 5. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ā„ 25% and ā¤ 90% predicted at Screening. 6. Able to walk ā„ 150 meters during the 6-minute walk test (6MWT) at Screening. 7. Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods. 8. Male subjects must practice true abstinence or use a barrier method of contraception. 9. Additional inclusion criteria apply. Progressive Pulmonary Fibrosis (PPF) Sub-Study: 1. Met all inclusion criteria described for IPF subjects other than Inclusion Criterion 5. 2. Features of diffuse fibrosing lung disease of > 10% on HRCT by central reading. 3. Investigator-documented ā„ 5% annualized relative decline in FVC in past 24 months from Screening Visit 1.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 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
Trial ID:
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. |
NCT03142191 |
Phase
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 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Zoran Popmihajlov, MD |
Principal Investigator Affiliation | Celgene |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Brazil, Canada, Colombia, Germany, Greece, Romania, Russian Federation, Taiwan, Turkey, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases |
Approximately 165 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 (55 subjects per arm) to treatment with oral CC-90001or matching placebo for an initial 24 weeks. The randomization will be stratified based on the concurrent administration of SOC (Yes/No). Subjects completing the 24-week Double-blind Treatment Phase will continue onto the 80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to receive 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 not on concurrent SOC therapy will have the opportunity, if deemed appropriate by the Investigator, to receive allowed standard of care (SOC). The exploratory Progressive Pulmonary Fibrosis (PPF) sub study will evaluate the efficacy, safety, PK, quality of life and exploratory PD of one PO treatment dose regimen of CC-90001, compared with placebo, for an initial 24 weeks of treatment, in subjects with PPF and long-term safety in the 80-week Active Treatment Extension Phase when all PPF subjects will receive CC-90001. Approximately 45 non-SOC subjects will be randomized in this sub study. 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 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.
Arms
Experimental: CC-90001 400 mg PO QD
55 subjects will be randomized to CC-90001 400mg
Experimental: CC-90001 200 mg PO QD
55 subjects will be randomized to CC-90001 200mg
Placebo Comparator: Placebo PO QD
55 subjects will be randomized to placebo
Experimental: CC-90001 400 mg PO QD- Sub-Study
30 subjects will be randomized to CC-90001 400mg
Placebo Comparator: Placebo PO QD- Sub-Study
15 subjects will be randomized to placebo
Interventions
Drug: - CC-90001
CC-90001 is a potent, selective inhibitor of JNK.
Other: - Placebo
Placebo
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.
Status
Not yet recruiting
Address
Loma Linda Univ Medical Center
Loma Linda, California, 92354
Status
Recruiting
Address
Cedars Sinai Medical Center Rheumatology
Los Angeles, California, 90048
Status
Recruiting
Address
University of California Davis Health System
Sacramento, California, 95817
Status
Recruiting
Address
Stanford University Pulmonary and Critical Care Clinic
Stanford, California, 94305
Status
Recruiting
Address
University of Florida
Gainesville, Florida, 32610
Status
Completed
Address
University of Miami and Sylvester Cancer Center
Miami, Florida, 33136
Status
Recruiting
Address
University of Louisville
Louisville, Kentucky, 40202
Status
Recruiting
Address
The Lung and Research Center, LLC
Chesterfield, Missouri, 63017
Status
Recruiting
Address
Mt. Sinai School of Medicine
New York, New York, 10029
Status
Recruiting
Address
Duke University Health System - Duke Pulmonary Transplant Clinic
Durham, North Carolina, 27710
Status
Recruiting
Address
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Status
Recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44121
Status
Recruiting
Address
Pulmonary & Sleep Center of Oklahoma
Tulsa, Oklahoma, 74137
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Status
Recruiting
Address
Baylor University Medical Center
Dallas, Texas, 75246
Status
Recruiting
Address
University of Utah Health Care
Salt Lake City, Utah, 84132
Status
Recruiting
Address
University of Vermont
Burlington, Vermont, 05405
International Sites
Status
Recruiting
Address
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Status
Recruiting
Address
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Status
Recruiting
Address
Mater Medical Centre
South Brisbane, Queensland, 4101
Status
Recruiting
Address
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Status
Recruiting
Address
Flinders Medical Centre
Bedford Park, South Australia, 5042
Status
Recruiting
Address
Royal Melbourne Hospital
Parkville, Victoria, 3050
Status
Recruiting
Address
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Status
Recruiting
Address
Institute for Respiratory Health Inc
Nedlands, Western Australia, 6009
Status
Recruiting
Address
St Vincent Hospital - Sydney
Darlinghurst, , 2010
Status
Recruiting
Address
Clinica de Pneumologia S/S
Goiania, GoiƔs, 74110-030
Status
Recruiting
Address
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, 90085-074
Status
Recruiting
Address
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande Do Sul, 91350-200
Status
Recruiting
Address
Hospital Ernesto Dornelles
Porto Alegre, , 90610-093
Status
Not yet recruiting
Address
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio de Janeiro, , 21941
Status
Recruiting
Address
Faculdade de Medicina do ABC
Santo Andre, , 09060-650
Status
Recruiting
Address
Incor - Instituto do Coracao HCFMUSP
Sao Paulo, , 01414-001
Status
Recruiting
Address
Kelowna & Respiratory Allergy Clinic
Kelowna, British Columbia, V1W 1V3
Status
Recruiting
Address
The Lung Centre Respiratory Clinic - Vancouver General Hospital Location
Vancouver, British Columbia, V5Z 1M9
Status
Recruiting
Address
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Status
Completed
Address
Centro de Reumatologia y Ortopedia SAS
Barranquilla, , 080020
Status
Recruiting
Address
Centro Especializado en Enfermedades Pulmonares
BogotĆ”, ,
Status
Recruiting
Address
Centro Medico Imbanaco
Cali, ,
Status
Completed
Address
Helios Klinikum Emil Von Behring
Berlin, , 14165
Status
Recruiting
Address
Ruhrlandklinik University Hospital
Essen, , 45239
Status
Recruiting
Address
AGAPLESION EV. KRANKENHAUS MITTELHESSEN gGmbH
Giessen, , 35398
Status
Completed
Address
Universitatsklinikum Heidelberg
Heidelberg, , 69120
Status
Completed
Address
Waldburg-Zeil Kliniken -Fachkliniken Wangen
Wangen Im Allgaeu, , 88239
Status
Completed
Address
Democritus University of Thrace
Alexandroupolis, , 68100
Status
Completed
Address
University General Hospital of Alexandroupolis
Alexandroupolis, , 68100
Status
Completed
Address
University General Hospital Attikon
Haidari, , 12462
Status
Completed
Address
General Hospital of Heraklion Benizeleio Pananeio
Heraklion, , 71409
Status
Completed
Address
University of Crete - University General Hospital of Heraklion
Iraklio, , 711 10
Status
Completed
Address
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca
Cluj-Napoca, ,
Status
Completed
Address
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara
Timisoara, , 300312
Status
Recruiting
Address
Ural State Medical Academy - Medical Association Novaya Bolnitsa
Ekaterinburg, , 620109
Status
Recruiting
Address
City clinical hospital No 9
Izhevsk, , 426063
Status
Completed
Address
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul
Kemerovo, , 650002
Status
Not yet recruiting
Address
TSBIH Territorial Clinical Hospital
Krasnoyarsk, , 660022
Status
Recruiting
Address
Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR
Moscow, , 107564
Status
Recruiting
Address
Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No.
Moscow, ,
Status
Recruiting
Address
Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
Nizhny Novgorod, , 603011
Status
Recruiting
Address
Republican Hospital
Petrozavodsk, , 185019
Status
Recruiting
Address
FSBHI Clincial Research Institute of Phithisioplulmonoloyg
Saint Petersburg, , 191036
Status
Recruiting
Address
Pavlov First Saint Petersburg State Medical University
Saint-Petersburg, , 197022
Status
Recruiting
Address
Saratov Regional Clinical Hospital
Saratov, , 410053
Status
Recruiting
Address
Vvedenskaya Hospital
St. Petersburg, , 191180
Status
Completed
Address
Saint-Petersburg State Institution of Healthcare
St. Petersburg, , 193312
Status
Recruiting
Address
SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev
Yaroslavl, , 150003
Status
Completed
Address
Buddhist Dalin Tzu Chi General Hospital
Dalin, , 62247
Status
Recruiting
Address
Kaohsiung Medical University Hospital
Kaohsiung, , 807
Status
Completed
Address
China Medical University Hospital
Taichung City, , 40447
Status
Completed
Address
National Taiwan University Hospital
Taipei, Zhongzheng Dist., , 10002
Status
Recruiting
Address
Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital
Bornova, , 35100
Status
Completed
Address
Uludag Universitesi Tip Fakultesi
Bursa, , 16059
Status
Completed
Address
Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty
Istanbul, , 34098
Status
Completed
Address
Izmir Dr.Suat Seren Chest Diseases Hospital
Izmir, , 35100
Status
Recruiting
Address
Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council
Dnipro, , 49023
Status
Recruiting
Address
Regional Phthisiopulmonological Center
Ivano-Frankivsk, , 76018
Status
Recruiting
Address
Kharkiv City Clinical Hospital #13
Kharkiv, , 61124
Status
Recruiting
Address
CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine
Kharkiv, , 61204
Status
Recruiting
Address
State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine
Kyiv, , 03115
Status
Recruiting
Address
SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences
Kyiv, , 03680
Status
Recruiting
Address
Birmingham Chest Clinic
Birmingham, , B3 3HX
Status
Recruiting
Address
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, , HU16 5JQ
Status
Recruiting
Address
Hinchingbrooke Hospital
Huntingdon, , PE29 6NT
Status
Recruiting
Address
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds, , LS9 7TF
Status
Recruiting
Address
University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH
Leicester, , LE3 9QP
Status
Recruiting
Address
Aintree University Hospital
Liverpool (Walton Centre), , L9 7LJ
Status
Recruiting
Address
University Hospital Llandough
Llandough, , CF64 2XX
Status
Recruiting
Address
University College London Hospitals
London, , NW1 2PG
Status
Recruiting
Address
Royal Victoria Infirmary
Newcastle, , NE1 4LP
Status
Recruiting
Address
Norfolk and Norwich University Hospital
Norwich, , NR4 7UY
Status
Recruiting
Address
The University of Nottingham - Nottingham Respiratory Research Unit NRRU
Nottingham, , NG5 1PB
Status
Recruiting
Address
Salford Royal
Salford, , M6 8HD
Status
Recruiting
Address
Southampton General Hospital
Southhampton, , SO01 6YD
Status
Recruiting
Address
Southmead Hospital
Westbury-on-Trym/ Bristol, , BS10 5NB