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    Summary
    EudraCT Number:2016-003473-17
    Sponsor's Protocol Code Number:CC-90001-IPF-001
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2016-003473-17
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary Fibrosis
    A.4.1Sponsor's protocol code numberCC-90001-IPF-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinical Trial Disclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18882601599
    B.5.5Fax number+19132660394
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CC-90001
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1403859-14-2
    D.3.9.2Current sponsor codeCC-90001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IDIOPATHIC PULMONARY FIBROSIS
    E.1.1.1Medical condition in easily understood language
    chronic, progressive disease that causes scarring (fibrosis) in lungs
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067761
    E.1.2Term Exacerbation of idiopathic pulmonary fibrosis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of CC-90001, 200 mg and 400 mg, when orally administered (PO) once
    daily (QD), compared with placebo, on percent of predicted forced vital capacity (FVC) after
    24 weeks of treatment in subjects with IPF.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of CC-90001, 200 mg and 400 mg PO QD, compared to placebo, after 24 weeks of treatment in subjects with IPF, on:
    - FVC (milliliters [mL])
    - Six-minute Walk Test (6MWT)
    - Disease progression
    - Heath-related quality of life: St. George’s Respiratory Questionnaire (SGRQ) and University of California San Diego-Shortness of Breath Questionnaire (UCSDSOBQ)
    - Dose response
    - Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or female ≥ 40 years of age at the time of signing the
    informed consent form (ICF)
    2. Subject must understand and voluntarily sign an ICF prior to any
    study-related assessments/procedures being conducted
    3. Subject is willing and able to adhere to the study visit schedule and
    other protocol requirements
    4. Investigator has considered all available IPF treatment options with
    the potential subject before consenting the subject for participation in
    the study
    5. Subject was diagnosed with IPF within 5 years of Screening.
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    6. Diagnosis of IPF is supported by HRCT, as described in Table 3 and
    Appendix G of the Protocol.
    7. Extent of fibrotic changes (eg, honeycombing, reticular changes)
    greater than the extent of emphysema on HRCT scan, as determined by
    centralized review
    8. No features supporting an alternative diagnosis on transbronchial
    biopsy, bronchoalveolar lavage (BAL), or SLB, if performed prior to
    Screening
    9. Percent predicted forced vital capacity (% FVC) ≥ 45% and ≤ 95% at
    Screening confirmed by centralized review
    10. Change in FVC (measured in milliliters [mL]) between Screening and
    Day 1 less than a 10% relative difference, calculated as: the absolute
    value of 100% * (Screening FVC [mL] - Day 1 FVC [mL]) / Screening FVC
    (mL)
    11. Hemoglobin-corrected percent predicted diffusion capacity of the
    lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at
    Screening
    12. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at
    Screening
    13. Females of childbearing potential (FCBP) must:
    a. Have two negative pregnancy tests as verified by the Investigator
    prior to starting IP. She must agree to ongoing pregnancy testing during
    the course of the study, and after end of study treatment. This applies
    even if the subject practices true abstinence* from heterosexual contact.
    b. Either commit to true abstinence* from heterosexual contact (which
    must be reviewed on a monthly basis and source documented) or agree
    to use two effective birth control methods (for example: birth control
    pills, condoms, etc) at the same time, and be able to comply with,
    effective contraception without interruption, 28 days prior to starting IP,
    during the study therapy (including dose interruptions), and for 28 days
    after discontinuation of IP
    14. Male subjects must:
    Practice true abstinence (which must be reviewed on a monthly basis)
    or agree to use condoms not made out of natural [animal] membrane
    during sexual contact with a pregnant female or a female of childbearing
    potential while participating in the study, during dose interruptions and
    for at least 28 days following IP discontinuation, even if he has
    undergone a successful vasectomy.
    E.4Principal exclusion criteria
    1. Subject has any significant medical condition, laboratory abnormality,
    or psychiatric illness that would prevent the subject from participating in
    the study
    2. Subject has any condition including the presence of laboratory
    abnormalities, which places the subject at unacceptable risk if he/she
    were to participate in the study
    3. Subject has any condition that confounds the ability to interpret data
    from the study
    4. Significant clinical worsening of IPF between Screening and Baseline
    (Visit 2), in the opinion of the Investigator
    5. Subjects with any of the following laboratory criteria:
    • White blood cell count (WBC) < 3500/mm3 (< 3.5 X 109/L) or >
    14,000/mm3 (> 14 X 109/L)
    • Platelet count < 120,000/μL (< 120 X 109/L)
    • Serum creatinine > 1.5 mg/dL (> 132.6 μmol/L)
    • Aspartate aminotransferase (AST/SGOT) > 1.5 X upper limit of normal
    (ULN)
    • Alanine aminotransferase (ALT/SGPT) > 1.5 X upper limit of normal
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    (ULN)
    • Total bilirubin > 2 mg/dL (> 34.2 μmol/L)
    • Hemoglobin < 10 g/dL (< 100 g/L)
    6. Subject with a QTcF > 450 msec
    7. Any condition other than IPF that in the opinion of the Investigator is
    likely to result in the death of the subject within the next year
    8. Inability to obtain reproducible, high-quality pulmonary function tests.
    9. Evidence of clinically relevant airways obstruction (ie, FEV1/FVC <
    0.7) at Screening and/or significant respiratory disorder/pathology (eg,
    pulmonary arterial hypertension requiring treatment, asthma,
    tuberculosis, sarcoidosis, hypersensitivity pneumonitis, aspergillosis,
    asbestosis, neoplastic disease, cystic fibrosis or other interstitial lung
    disease) other than IPF
    10. Subject is likely to have lung transplantation during the first 24
    weeks of the study (being on transplantation list is acceptable for
    participation)
    11. Impairment (other than dyspnea) limiting the ability to comply with
    study requirements (eg, pulmonary function tests, 6-minute walk test)
    12. Subjects using any therapy targeted to treat IPF including, but not
    limited to, pirfenidone, nintedanib, endothelium receptor antagonists
    (eg, bosentan, ambrisentan), interferon gamma-1b, imatinib mesylate,
    N-acetylcysteine, azathioprine, cyclophosphamide, methotrexate,
    mycophenolate mofetil, and cyclosporine, oral steroids (eg, prednisone >
    12.5 mg/day or equivalent) and oral anticoagulants within 4 weeks of
    the Screening Visit. (Note: Oral anticoagulants for conditions other than
    IPF are permitted. Subjects should not discontinue any of these
    therapies for the sole purpose of participating in this study.)
    13. Use of any cytokine modulator/biologic, such as etanercept,
    adalimumab, efalizumab, infliximab, or rituximab within 12 weeks of
    randomization
    14. Use of an inhaled long-acting bronchodilator within 24 hours of the
    Screening Visit or short-acting bronchodilator within 8 hours of the
    Screening Visit
    15. Use of drugs that are known to cause hepatotoxicity, such as, but not
    limited to, acetaminophen (paracetamol) at dosages of > 3 grams/day
    and niacin dosage of > 2 grams/day while on study or within 2 weeks of
    first dose of IP
    16. Use of any medications that are substrates of one or more of the
    transporters P-gp, BCRP, OAT3, OATP1B1, OATP1B3, and OCT2 and have
    a narrow therapeutic index (eg, digoxin, mycophenolate mofetil)
    17. History of recent (within 6 months of Screening) deep vein
    thrombosis (DVT) or pulmonary embolism (PE) and/or recurrent DVT or
    recurrent PE
    18. History of cardiac valve replacement requiring chronic
    anticoagulation therapy
    19. History of congenital and/or acquired immunodeficiencies (eg,
    common variable immunodeficiency, human immunodeficiency virus
    [HIV], etc)
    20. History of hepatitis B and/or hepatitis C, including those considered
    successfully treated/cured
    21. Active or history of recurrent bacterial, viral, fungal, mycobacterial
    or other infections (including, but not limited to, atypical mycobacterial
    disease and herpes zoster), or any major episode of infection requiring
    hospitalization or treatment with intravenous or oral antibiotics within 4
    weeks of the Screening Visit and at any time during the Screening Phase,
    up through the first dose of IP
    22. History of latent or active TB, unless there is medical record
    documentation of successful completion of a standard course of
    treatment
    23. Clinical diagnosis of any connective tissue disease, including, but not
    limited to, scleroderma, polymyositis/dermatomyositis, systemic lupus
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    erythematosus, and rheumatoid arthritis
    24. History of end-stage renal disease requiring dialysis
    25. History of severe hepatic impairment or end-stage liver disease
    26. History of Gilbert's syndrome
    27. History of alcohol or drug abuse within 6 months prior to Screening
    Please refer to the Protocol for the full list of exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Forced vital capacity (FVC) - Percentage point change in % predicted FVC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    E.5.2Secondary end point(s)
    1. FVC - Absolute change and rate of decline in FVC (expressed in mL)
    2. 6-minute Walk Test (6MWT) with Borg Scale:
    - Change in the distance walked during the 6MWT as measured in meters (m)
    - Change in dyspnea rating on Borg Scale
    3. Disease progression:
    - Death from respiratory failure, or
    - Absolute decrease of ≥ 10% from baseline in % predicted FVC at two consecutive evaluations at a minimum of 4 weeks between evaluations, or
    - Decrease from baseline of ≥ 50 meters in 6MWT distance (in the absence of a readily explainable cause, such as injury or trauma), or
    - Unexplained worsening hypoxemia (an absolute decrease from baseline of 4% or more in SpO2).
    4. Quality of life :
    - Change from Baseline in total score and domains including cough on the Saint George’s Respiratory Questionnaire (SGRQ)
    - Change from Baseline in the University of California San Diego Shortness of Breath Questionnaire (UCSD- SOBQ)
    5. Safety and tolerability - Type, frequency, severity, and relationship of AEs, clinical laboratory tests including urine cytology, 12-lead ECG, vital signs, and physical examination
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. FVC - Baseline through Week 24
    2. 6-minute Walk Test (6MWT) with Borg Scale:
    - Baseline through Week 24;
    - Baseline through Week 52;
    - Week 24 through Week 52
    3. Disease progression - Baseline through Week 24
    4. Quality of life - Baseline through Week 24
    5. Safety and tolerability - Signing of the informed consent form through Week 56 (4-week post-treatment observational follow-up)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Colombia
    France
    Germany
    Greece
    Romania
    Russian Federation
    Taiwan
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 135
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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