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    Summary
    EudraCT Number:2010-020688-18
    Sponsor's Protocol Code Number:CQAX576A2203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-01-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-020688-18
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multipledose, exploratory proof of concept study to assess the safety, tolerability, efficacy, pharmacodynamics and
    pharmacokinetics of QAX576 in patients with rapidly progressive idiopathic pulmonary fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of QAX576 in Patients With Progressive Idiopathic Pulmonary Fibrosis (IPF)
    A.4.1Sponsor's protocol code numberCQAX576A2203
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharmaceuticals UK Ltd
    B.5.2Functional name of contact pointMedical Information Services
    B.5.3 Address:
    B.5.3.1Street AddressFrimley Business Park
    B.5.3.2Town/ cityCamberley, Surrey
    B.5.3.3Post codeGU16 7SR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 01276 698370
    B.5.6E-mailmedinfo.uk@novartis.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 QAX576
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeQAX576
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder and solvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with rapidly progressive idiopathic pulmonary fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the safety and tolerability of multiple intravenous dosing of QAX576 in
    patients with IPF
    • To evaluate the effect of multiple intravenous dosing of QAX576 on lung function
    assessed by FVC at 1 year as compared to baseline
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of multiple intravenous dosing of QAX576 on additional measures of clinical efficacy, including:
    • all-cause mortality, time to clinical worsening defined as 10% fall in FVC or 15% fall
    in DLco, lung transplant or lung disease (IPF)-related death.
    • incidence of exacerbation of IPF.
    • lung volume (TLC, RV, FRV) and diffusing capacity of the lung for carbon monoxide
    (DLco).
    • 6 minute walk distance, pulse oximetry and heart rate recovery.
    • progression of fibrosis in the lungs as measured by Quantitative High Resolution
    Computerized Tomography (HRCT).
    • patient reported symptoms.
    2. To evaluate the pharmacokinetics of QAX576 in this patient population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any participation in the study.
    2. Male or female subjects of ≥18 years of age to ≤80 years of age.
    3. Diagnosis of IPF, based on an appropriate clinical definition of IPF as detailed in the
    (ATS/ERS/JRS/ALAT statement: Idiopathic Pulmonary Fibrosis:Evidence-based Guidelines for diagnosis and management (Raghu G et al 2011)
    Diagnosis must be confirmed by diagnostic HRCT or lung biopsy
    4. A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).
    5. Forced Vital Capacity FVC) ≥50% of predicted at Screening.
    6. Diffusing capacity for carbon monoxide (DLco) uncorrected ≥30 of predicted at
    Screening
    7. Body mass index (BMI) must be within the range 18 to 40
    8. Subjects should be able to communicate well with the investigator and to understand and comply with the requirements of the study.
    9. Female patients must be of non-childbearing potential:
    Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In the case of oophorrectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    E.4Principal exclusion criteria
    1. Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as ‘smokers’ per the local lab.
    2. Participation in any therapeutic trial within four (4) weeks prior to initial dosing or
    longer if required by local regulations, and for any other limitation of participation based on local regulations. For trials involving study medication, subjects dosed with active study medication should not be screened until ≥ five half-lives of the study medication have passed (or as guided by local regulations if longer).
    3. Participation in an IPF therapeutic trial in the 8 weeks (or 16 weeks in the case of an experimental monoclonal antibody) prior to Screening.
    4. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial
    dosing, or longer if required by local regulation.
    5. A past medical history of clinically significant ECG or cardiac abnormalities (NB, cases of right ventricular hypertrophy, secondary pulmonary hypertension or right bundle branch block should be discussed with the sponsor).
    6. FEV1/FVC ratio < 0.6 at screening (pre or post-bronchodilator).
    7. Lung residual volume > 120% predicted at Screening.
    8. High-Resolution Computed Tomography (HRCT) showing only ground glass infiltrates without other typical features of pulmonary fibrosis such as basilar predominant reticular infiltrates, honeycombing, and traction bronchiectasis, unless there is lung biopsy proven evidence of predominant UIP.
    9. Subjects who within the preceding 6 months have traveled to or emigrated from an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia, South America and Africa, or who have had a prior diagnosis of schistosomiasis must have 3 negative stool ova and parasite studies.
    10. Any condition other than pulmonary fibrosis which in the opinion of the investigator is
    likely to result in the death of the patient within the next year.
    11. History of unstable or deteriorating cardiac or neurological disease.
    12. Chronic treatment for IPF with the following drugs at randomization. If a subject is being treated with a prohibited therapy and the study investigator feels it is appropriate to discontinue the therapy, the duration of the washout prior to andomization will be discussed with the Sponsor on a case-by-case basis.
    • Oral corticosteroids (> 20 mg/day of prednisone or equivalent),
    • Immunosuppressive or cytotoxic drugs including cyclophosphamide and
    azathioprine,
    • Antifibrotic drugs including pirfenidone, D penicillamine, colchicine, TNFα
    blocker, imatinib and interferon γ,
    • Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day).
    13. Exposure to human therapeutic monoclonal antibodies within the 3 months prior to the first dose or known hypersensitivity to monoclonal antibodies or human plasma products.
    14. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
    15. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    16. History of drug or alcohol abuse within the 12 months prior to dosing.
    17. Nursing mothers.
    18. Subjects should not be enrolled if the investigator feels they are likely to require a lung transplant in the next 4 months.
    19. Subjects who are participating in a pulmonary rehabilitation program should continue to do so. If the study investigator feels that a subject should be started on a pulmonary rehabilitation program, the rehabilitation should be started at least 8 weeks prior to randomization to establish a stable baseline.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    • The primary efficacy endpoint is change from baseline in FVC measurement at 52 weeks as assessed at each clinical visit post-baseline.
    Additional details are included in section 9.4 of the clinical study protocol

    Secondry endpoints:
    • all-cause mortality, time to clinical worsening defined as 10% fall in FVC or 15% fall in DLco, lung transplant or lung disease (IPF)-related death.
    • incidence of exacerbation of IPF.
    • lung volume (TLC, RV, FRV) and diffusing capacity of the lung for carbon monoxide (DLco).
    • 6 minute walk distance, pulse oximetry and heart rate recovery.
    • progression of fibrosis in the lungs as measured by Quantitative High Resolution
    Computerized Tomography (HRCT).
    • patient reported symptoms.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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.8.3 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 concerned8
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2011-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-04-26
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