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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-001281-86
    Sponsor's Protocol Code Number:CNTO888PUL2001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-001281-86
    A.3Full title of the trial
    A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis
    A.4.1Sponsor's protocol code numberCNTO888PUL2001
    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 SponsorCentocor B.V.
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.1Product nameCNTO888
    D.3.2Product code CNTO888
    D.3.4Pharmaceutical form Powder 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 codeCNTO888
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 placeboSolution 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
    Idiopathic pulmonary fibrosis (IPF)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the efficacy (as measured by pulmonary function) and safety of
    CNTO 888 in subjects with IPF.
    E.2.2Secondary objectives of the trial
    • To assess the effect of CNTO 888 on measures of disease progression.

    • To assess the effect of CNTO 888 on patient reported outcomes, functional capacity measurements, and health-related quality of life in subjects with IPF.

    • To assess the PK and PD of CNTO 888 in subjects with IPF.
    E.2.3Trial contains a sub-study Yes
    E.3Principal inclusion criteria
    1. Aged 40 to 80, inclusive.

    a. Subjects who are aged 40 years to < 50 years of age at the time of screening
    will be required to have surgical lung biopsy evidence of UIP in order to be
    considered eligible for the trial.

    2. Physician diagnosis of IPF (according to a modified version of the ATS/ERS criteria; ATS, 2000) within 4 years of screening. See Attachment 3 for a suggested algorithm for the evaluation of a subject with suspected IPF. Subjects must meet all of the major criteria and 3 of the 4 minor criteria listed below:

    Major criteria (must meet all)
    a. Exclusion of other known causes of interstitial lung disease, such as certain drug toxicities, environmental exposures, and connective tissue diseases.
    b. Abnormal pulmonary function studies that include evidence of restriction (reduced vital capacity, often with an increased FEV1/FVC ratio) and impaired gas exchange (increased alveolar-arterial oxygen gradient [P(A-a)O2] or evidence of desaturation at rest or exercise or decreased DLCO).
    c. Bibasilar reticular abnormalities with minimal ground-glass opacities on HRCT scans.

    Minor Criteria (must meet 3)
    a. Age > 50 years.
    b. Insidious onset of otherwise unexplained dyspnea on exertion.
    c. Duration of illness ≥ 3 months.
    d. Bibasilar, inspiratory crackles (dry or “Velcro-type” in quality).

    3. Have surgical lung biopsy evidence of UIP and/or HRCT scan-based diagnosis of IPF. In the absence of surgical lung biopsy, an HRCT scan obtained within 3 months prior to or at screening must be available for review.

    4. Have evidence of progressive IPF disease activity despite current treatment. Progressive IPF disease activity, for the purposes of this protocol, is defined as having 1 or more of the following within the past 12 months:
    a. Relative decrease of ≥ 10% in FVC.
    b. Relative decrease of ≥ 15% in DLCO.
    c. Evidence of clinically significant worsening on HRCT (eg, development of honeycombing, increase in opacities).
    d. Significant worsening of dyspnea at rest or with exertion.

    5. Evidence of recent stability of percent-predicted FVC (defined as not having changed > 15% at the baseline visit relative to the screening visit).

    6. FVC ≥ 50% of the predicted value at screening.

    7. Women of childbearing potential must have a negative serum pregnancy test result at screening. Women of childbearing potential and all men must be using adequate birth control measures and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last infusion of study agent.

    8. Are considered eligible according to the following TB screening criteria:
    a. Have no history of latent or active TB prior to screening.
    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c. Have had no recent close contact with a person with active TB.
    d. Within 2 months prior to the first administration of study agent, have negative diagnostic TB test results (defined as a negative QuantiFERON-TB Gold test).
    e. Have a chest radiograph (both posterior-anterior and lateral views) if clinically indicated or HRCT taken within 3 months prior to screening and read by a qualified radiologist, with no clear evidence of current active TB or old inactive TB.

    9. Capable of understanding subject assessment forms.

    10. Have provided signed, written, informed consent before receiving any protocol
    specific procedures.

    11. Willing to adhere to the study visit schedule and other protocol requirements.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria may not be enrolled in the study:

    1. Have evidence of interstitial pneumonia other than IPF.

    2. Diagnosis of IPF is not confirmed by HRCT or lung biopsy results.

    3. Partial pressure of oxygen in arterial blood (PaO2) < 55 mmHg (sea level) or 50 mmHg (altitude) at rest on room air. If arterial blood gas results are not available, an oxygen saturation via pulse oximetry (SpO2) < 88% with O2 supplementation at rest.

    4. Known clinically significant pulmonary hypertension requiring vasodilator therapy (eg, calcium channel blockers, prostacyclin or prostacyclin analogs, nitric oxide, denosine) or chronic anticoagulation therapy.

    5. Have a diagnosis of other significant respiratory disorder (eg, asthma, TB, sarcoidosis, aspergillosis, chronic obstructive pulmonary disease [COPD], or cystic fibrosis).

    6. Have obstruction on prebronchodilator PFTs (defined as FEV1/FVC < 0.7) at screening.

    7. Demonstrate an increase in FEV1 ≥ 12% postbronchodilator.

    8. Have a predicted life expectancy less than 1 year.

    9. Previous treatment for IPF with an investigational/experimental medication within 6 weeks, or within 5 t1/2 of the investigational/experimental medication, whichever is longer, prior to screening or are participating in another investigative study.

    10. Current treatment with sildenafil, IFN-γ, mycophenolate, or endothelin receptor antagonists.

    11. Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease, or any laboratory abnormality which would pose/suggest a risk to the subject by participation in the study.

    12. Known to be seropositive for HIV, known active hepatitis A, B, or C infection, or ALT/SGPT and/or AST/SGOT > 2 times the upper limit of normal at screening.

    13. Within 3 months prior to screening, have had a clinically important, serious infection (eg, hepatitis, pneumonia, or pyelonephritis), have been hospitalized for an infection, or have been treated with IV antibiotics for an infection. Less serious infections (eg, acute upper respiratory tract infection or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.

    14. Opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii) within 6 months prior to screening.

    15. Received any live attenuated vaccination (eg, FluMist) within 3 months prior to screening or are expected to receive any live attenuated vaccinations during the trial or up to 3 months after the last administration of study agent. Inactivated, injectable influenza and pneumococcal vaccines are permissible.

    16. Serious concomitant illness that could interfere with the subject’s participation in the study.

    17. History of substance abuse (drugs or alcohol) within the 3 years prior to screening, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the subject’s adherence to protocol requirements (eg, psychiatric disease, lack of motivation, travel).

    18. Major surgery within 1 month prior to screening or planned surgery during the
    study.

    19. Currently listed for lung transplantation.

    20. Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence for at least 3 months).

    21. Have a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).

    22. Known allergies or clinically significant reactions to murine, murine-human chimeric, or human proteins or other components of the product.

    23. Significant bleeding diathesis or excessive risk of bleeding, including chronic
    anticoagulant therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the rate of percent change (relative to baseline per 4-week interval) in FVC through Week 52.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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 Information not present in EudraCT
    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 35
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
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