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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142191
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Fibrosis Idiopathic Interstitial Pneumonias Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Drug: CC-90001 Other: Placebo Phase 2

Detailed Description:

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-90001 (200 mg QD or 400 mg QD) or 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).

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : January 26, 2023


Arm Intervention/treatment
Experimental: CC-90001 400 mg PO QD
55 subjects will be randomized to CC-90001 400mg
Drug: CC-90001
CC-90001 is a potent, selective inhibitor of JNK.

Experimental: CC-90001 200 mg PO QD
55 subjects will be randomized to CC-90001 200mg
Drug: CC-90001
CC-90001 is a potent, selective inhibitor of JNK.

Placebo Comparator: Placebo PO QD
55 subjects will be randomized to placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Percentage point change in % predicted Forced vital capacity (FVC) [ Time Frame: Up to approximately 24 weeks ]
    Mean change from Baseline of percent predicted FVC value between either active treatment group and the placebo group.


Secondary Outcome Measures :
  1. Absolute change and rate of decline in FVC [ Time Frame: Up to approximately 24 weeks ]
    Absolute change and rate of decline in FVC (expressed in mL) from baseline through Week 24

  2. 6-minute Walk Test (6MWT) with Borg Scale [ Time Frame: Up to approximately 104 weeks ]
    Change in the distance walked during the 6MWT as measured in meters (m)

  3. Disease Progression [ Time Frame: Up to approximately 24 weeks ]
    Time to disease progression

  4. Quality of Life - Saint George's Respiratory [ Time Frame: Up to approximately 24 weeks ]

    The SGRQ is a quality of life health questionnaire that has been validated in IPF. It consists of 76 items in three domains:

    • Symptoms
    • Activity
    • Impact of disease on daily life.

  5. Quality of life- University of California San Diego Shortness of Breath Questionnaire (UCSD- SOBQ) [ Time Frame: Up to approximately 24 weeks ]
    The UCSD-SOBQ is a 24-item dyspnea questionnaire that asks subjects to rate themselves from 0 ("Not at all") to 5 ("Maximally or unable to do because of breathlessness") in two areas: 1) how short of breath they are while performing various activities (21 items); and 2) how much shortness of breath, fear of hurting themselves by overexerting, and fear of shortness of breath limit them in their daily lives (3 items).

  6. Adverse Events (AEs) [ Time Frame: Up to Week 108 ]
    Type, frequency, severity, and relationship of AEs, clinical laboratory tests including urine cytology, 12-lead ECG, vital signs, and physical examination

  7. Borg Scale [ Time Frame: Up to approximately 104 weeks ]
    This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal. How much difficulty is your breathing causing you right now?



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject understands and has voluntarily signed and dated an informed consent form

  1. Subject is male or female ≥ 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) ≥ 45% and ≤ 95% at Screening
  5. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at Screening.
  6. Able to walk ≥ 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142191


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

  Hide Study Locations
Locations
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United States, California
Cedars Sinai Medical Center Rheumatology Recruiting
Los Angeles, California, United States, 90048
University of California Davis Health System Recruiting
Sacramento, California, United States, 95817
Stanford University Pulmonary and Critical Care Clinic Recruiting
Stanford, California, United States, 94305
United States, Florida
University of Miami and Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
The Lung and Research Center, LLC Recruiting
Chesterfield, Missouri, United States, 63017
United States, New York
Mt. Sinai School of Medicine Recruiting
New York, New York, United States, 10029
United States, North Carolina
Duke University Health System - Duke Pulmonary Transplant Clinic Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44121
United States, Oklahoma
Pulmonary & Sleep Center of Oklahoma Recruiting
Tulsa, Oklahoma, United States, 74137
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
United States, Utah
University of Utah Health Care Recruiting
Salt Lake City, Utah, United States, 84132
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Australia, Queensland
Mater Medical Centre Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Institute for Respiratory Health Inc Recruiting
Nedlands, Western Australia, Australia, 6009
Australia
St Vincent Hospital - Sydney Recruiting
Darlinghurst, Australia, 2010
Brazil
Clinica de Pneumologia S/S Recruiting
Goiania, Goiás, Brazil, 74110-030
Irmandade da Santa Casa de Misericordia de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90085-074
Hospital Nossa Senhora da Conceicao Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
Hospital Ernesto Dornelles Recruiting
Porto Alegre, Brazil, 90610-093
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF) Not yet recruiting
Rio de Janeiro, Brazil, 21941
Faculdade de Medicina do ABC Recruiting
Santo Andre, Brazil, 09060-650
Incor - Instituto do Coracao HCFMUSP Recruiting
Sao Paulo, Brazil, 01414-001
Canada, British Columbia
Kelowna & Respiratory Allergy Clinic Recruiting
Kelowna, British Columbia, Canada, V1W 1V3
The Lung Centre Respiratory Clinic - Vancouver General Hospital Location Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Dr. Syed Anees Medicine Professional Corporation Recruiting
Windsor, Ontario, Canada, N8X 1T3
Colombia
Centro Especializado en Enfermedades Pulmonares Recruiting
Bogotá, Colombia
Centro Medico Imbanaco Recruiting
Cali, Colombia
Germany
Helios Klinikum Emil Von Behring Recruiting
Berlin, Germany, 14165
Ruhrlandklinik University Hospital Not yet recruiting
Essen, Germany, 45239
Pneumologische Klinik - Waldhof Elgershausen Recruiting
Greifenstein, Germany, 35753
Universitatsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Waldburg-Zeil Kliniken -Fachkliniken Wangen Completed
Wangen Im Allgaeu, Germany, 88239
Greece
Democritus University of Thrace Completed
Alexandroupolis, Greece, 68100
University General Hospital of Alexandroupolis Recruiting
Alexandroupolis, Greece, 68100
University General Hospital Attikon Completed
Haidari, Greece, 12462
General Hospital of Heraklion Benizeleio Pananeio Completed
Heraklion, Greece, 71409
University of Crete - University General Hospital of Heraklion Completed
Iraklio, Greece, 711 10
Romania
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca Terminated
Cluj-Napoca, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara Terminated
Timisoara, Romania, 300312
Russian Federation
Ural research Institute of Phthisiopulmonology Not yet recruiting
Ekaterinburg, Russian Federation, 620039
Ural State Medical Academy - Medical Association Novaya Bolnitsa Recruiting
Ekaterinburg, Russian Federation, 620109
City clinical hospital No 9 Recruiting
Izhevsk, Russian Federation, 426063
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul Completed
Kemerovo, Russian Federation, 650002
TSBIH Territorial Clinical Hospital Not yet recruiting
Krasnoyarsk, Russian Federation, 660022
Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR Recruiting
Moscow, Russian Federation, 107564
Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No. Recruiting
Moscow, Russian Federation
Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology Recruiting
Nizhny Novgorod, Russian Federation, 603011
Republican Hospital Recruiting
Petrozavodsk, Russian Federation, 185019
FSBHI Clincial Research Institute of Phithisioplulmonoloyg Recruiting
Saint Petersburg, Russian Federation, 191036
Pavlov First Saint Petersburg State Medical University Recruiting
Saint-Petersburg, Russian Federation, 197022
Saratov Regional Clinical Hospital Recruiting
Saratov, Russian Federation, 410053
Vvedenskaya Hospital Recruiting
St. Petersburg, Russian Federation, 191180
Saint-Petersburg State Institution of Healthcare Recruiting
St. Petersburg, Russian Federation, 193312
SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev Recruiting
Yaroslavl, Russian Federation, 150003
Taiwan
Buddhist Dalin Tzu Chi General Hospital Recruiting
Dalin, Taiwan, 62247
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
China Medical University Hospital Recruiting
Taichung City, Taiwan, 40447
National Taiwan University Hospital Recruiting
Taipei, Zhongzheng Dist., Taiwan, 10002
Turkey
Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital Recruiting
Bornova, Turkey, 35100
Uludag Universitesi Tip Fakultesi Recruiting
Bursa, Turkey, 16059
Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty Recruiting
Istanbul, Turkey, 34098
Izmir Dr.Suat Seren Chest Diseases Hospital Recruiting
Izmir, Turkey, 35100
Ukraine
Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council Recruiting
Dnipro, Ukraine, 49023
Regional Phthisiopulmonological Center Recruiting
Ivano-Frankivsk, Ukraine, 76018
Kharkiv City Clinical Hospital #13 Recruiting
Kharkiv, Ukraine, 61124
CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine Recruiting
Kharkiv, Ukraine, 61204
State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine Recruiting
Kyiv, Ukraine, 03115
SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences Recruiting
Kyiv, Ukraine, 03680
United Kingdom
Birmingham Chest Clinic Recruiting
Birmingham, United Kingdom, B3 3HX
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital Recruiting
Cottingham, United Kingdom, HU16 5JQ
Hinchingbrooke Hospital Recruiting
Huntingdon, United Kingdom, PE29 6NT
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH Recruiting
Leicester, United Kingdom, LE3 9QP
Aintree University Hospital Recruiting
Liverpool (Walton Centre), United Kingdom, L9 7LJ
University Hospital Llandough Recruiting
Llandough, United Kingdom, CF64 2XX
University College London Hospitals Not yet recruiting
London, United Kingdom, NW1 2PG
Royal Victoria Infirmary Recruiting
Newcastle, United Kingdom, NE1 4LP
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom, NR4 7UY
The University of Nottingham - Nottingham Respiratory Research Unit NRRU Recruiting
Nottingham, United Kingdom, NG5 1PB
Salford Royal Recruiting
Salford, United Kingdom, M6 8HD
Southampton General Hospital Recruiting
Southhampton, United Kingdom, SO01 6YD
Southmead Hospital Recruiting
Westbury-on-Trym/ Bristol, United Kingdom, BS10 5NB
Sponsors and Collaborators
Celgene
Investigators
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Study Chair: Zoran Popmihajlov, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03142191     History of Changes
Other Study ID Numbers: CC-90001-IPF-001
2016-003473-17 ( EudraCT Number )
U1111-1192-8549 ( Registry Identifier: WHO )
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Idiopathic Pulmonary Fibrosis (IPF)
Pulmonary Fibrosis
CC-90001
Safety
Efficacy
IPF
idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections