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    Summary
    EudraCT Number:2009-013267-19
    Sponsor's Protocol Code Number:ILR4660g
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-21
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-013267-19
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING
    STUDY TO EVALUATE LEBRIKIZUMAB (MILR1444A) IN ADULT PATIENTS WITH ASTHMA WHO ARE NOT TAKING INHALED CORTICOSTEROIDS (MOLLY)
    A.3.2Name or abbreviated title of the trial where available
    MOLLY
    A.4.1Sponsor's protocol code numberILR4660g
    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 SponsorGENENTECH, Inc.
    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 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 nameLebrikizumab
    D.3.2Product code MILR1444A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLebrikizumab
    D.3.9.1CAS number 953400-68-5
    D.3.9.2Current sponsor codeMILR1444A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 typeHumanized monoclonal 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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma in adult patients not taking inhaled corticosteroids
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objectives of this study are as follows;

    - To evaluate the efficacy of different doses of lebrikizumab compared with placebo as measured by relative change in pre-bronchodilator FEV1.

    - To evaluate the safety and tolerability of different doses of lebrikizumab.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    - To compare the efficacy among different doses of lebrikizumab as measured by relative change in pre-bronchodilator FEV1.

    - To evaluate the efficacy of different doses of lebrikizumab compared with placebo in a subgroup of IL-13 signature surrogate positive patients, as measured by relative change in pre-bronchodilator FEV1.

    - To evaluate the efficacy of different doses of lebrikizumab compared with placebo as measured by change in morning peak flow, peak flow variability, rescue medication use, and time to treatment failure.

    - To characterize the PK of lebrikizumab.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH LEBRIKIZUMAB STUDY ILR4660g. (Version date 15 Jun 2009).

    The primary objective of this sub-study is to perform exploratory analyses to generate hypotheses identifying genes associated with treatment response, toxicity,
    or disease risk. If such genetic hypotheses are identified, they may be tested in
    future clinical studies within this therapeutic area.
    E.3Principal inclusion criteria
    Patients must meet the following criteria to be eligible for study entry:

    103 Age ≥ 18 and ≤ 65 years at Visit 1

    105 Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality other than changes consistent with asthma

    107 Stable asthma defined by the following criteria (patients must meet all of the criteria):
    1. Diagnosis of asthma ≥ 12 months prior to Visit 1
    2. Bronchodilator response at Visit 1 or Visit 2
    3. Prebronchodilator FEV1 ≥ 60% and ≤85% predicted at Visit 3
    4. Stable disease: Relative change in pre-bronchodilator FEV1 (volume) from Visit 2 to Visit 3 is <15% (increase or decrease).
    Relative change in mean morning pre-bronchodilator peak flow between Visit 1 and 2 must be < 20% (increase or decrease) of the mean pre-bronchodilator peak flow between Visits 2 and 3.
    Daily use of albuterol metered dose inhaler (MDI) (or equivalent) must be < 10 puffs or ≤ 2 nonscheduled administrations (or any new use) of nebulized SABA therapy
    No required ICS, oral or parenteral corticosteroids
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:

    a.Medical Conditions
    201 Known malignancy or current evaluation for a potential malignancy. If treatment for a malignancy was completed at least 12 months prior to Visit 1 and no further treatment is anticipated by the patient’s oncologist during this study, then the patient may enroll.

    202 Patients with a new diagnosis of basal cell carcinoma or squamous cell skin carcinoma in the 12 months prior to the run-in period are excluded.

    203 Known immunodeficiency, including but not limited to HIV infection

    204 Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study

    205 Patients with elevated IgE levels for reasons other than allergy (including but not limited to parasitic infections, hyperimmunoglobulin E syndrome, allergic bronchopulmonary aspergillosis, and Wiskott-Aldrich syndrome)

    206 Patients with a history of or active infection with any GI nematodes (including, though not limited to, enterobiasis; trichuriasis; hookworm; strongyloidiasis; trichinellosis; ascariasis) or leishmaniasis or lymphatic filariasis; regardless of treatment status

    207 Any other medical condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications

    209 Lung disease other than asthma including but not limited to active infection

    b. Exposures
    210 Current smoker or former smoker with a lifetime smoking history of > 10 pack years.

    211 History of substance abuse that may impair or risk the patient’s full participation in the study, in the judgment of the investigator
    212 Participation in another interventional clinical trial (including interventional studies that does not include use of medication) within 30 days

    c.Medications
    213 Use of any of the excluded medications during the time periods listed in Table 1 of protocol

    214 Prior allergic reaction during the use (or possible use if blinded study) of a monoclonal antibody

    d. Reproductive Potential
    215 Patients (men and women) of reproductive potential who are not willing to use a highly effective method of contraception (see Appendix B) for the duration of the study or women who are pregnant or lactating at the time of random allocation

    216 Women with a positive serum pregnancy test
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome measure is the relative change in pre-bronchodilator
    FEV1 (volume) from baseline to Week 12.
    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 Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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) Yes
    F.1.3Elderly (>=65 years) No
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 200
    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)
    Patients will return to their standard of care. The study drug will not be available after study completion.
    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 Decision2009-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-21
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