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    Summary
    EudraCT Number:2020-001927-15
    Sponsor's Protocol Code Number:TV48574-AS-20031
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-09-17
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-001927-15
    A.3Full title of the trial
    A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults with T2-low/non-T2 Severe Uncontrolled Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if TEV-48574 is Effective in Relieving Asthma
    A.4.1Sponsor's protocol code numberTV48574-AS-20031
    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 SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Branded Pharmaceutical Products R&D, Inc.
    B.5.2Functional name of contact pointClinical Study Lead
    B.5.3 Address:
    B.5.3.1Street Address145 Brandywine Parkway
    B.5.3.2Town/ cityWest Chester, Pennsylvania
    B.5.3.3Post code19380
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016107273429
    B.5.6E-mailGordon.Raphael@tevapharm.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.3.1Product nameTEV-48574
    D.3.2Product code TEV-48574
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNTEV 48574
    D.3.9.1CAS number to be determ
    D.3.9.2Current sponsor codeTEV 48574
    D.3.9.3Other descriptive nameFully human IgG1 monoclonal antibody specific for TL1A
    D.3.9.4EV Substance CodeSUB187243
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 Yes
    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 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
    T2-low/non-T2 Severe Uncontrolled Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    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 PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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
    The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult patients with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).
    E.2.2Secondary objectives of the trial
    The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control.
    Other objectives include the evaluation of the safety and tolerability, device-related events, pharmacokinetics, and immunogenicity of TEV-48574.
    Potential exploratory biomarker objectives may include characterization of TEV-48574 responders and support of development of scalable tools to identify likely responders in future studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. The patient is a man or woman of any ethnic origin, at least 18 years of age at the time of signature of the informed consent form (ICF).
    b. The patient has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
    e. The patient has demonstrated ≥12% and ≥200mL response to a bronchodilator from baseline FEV1 within 30 minutes after 4 inhalations of albuterol/salbutamol HFA MDI (90 mcg ex-actuator) or equivalent (eg, Ventolin) at screening.
    f. The patient has asthma with a FEV1 ≥30% and <80% of the value predicted for age, height, sex, and race at screening. FEV1 must be performed using the office-based spirometer provided for the study. One pulmonary function test retest during the screening visit(s) period (up to 2 weeks) is allowed to fulfill this criterion.
    For further inclusion criteria, see protocol.
    E.4Principal exclusion criteria
    a. The patient has any other pulmonary diagnosis that in the opinion of the investigator and/or the clinical study physician could adversely affect patient safety or interpretation of study results. Examples include but are not limited to: chronic obstructive pulmonary disease, chronic bronchitis, or any respiratory condition that requires any chronic antibiotic use (some antibiotics can be immunomodulatory such as macrolides [eg, erythromycin, azithromycin and clarithomycin]), bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia, and interstitial lung disease (including eosinophilic granulomatosis with polyangiitis [EGPA] which is expressly prohibited), obstructive sleep apnea (sometimes referred to as sleep apnea or Pickwickian Syndrome), and gastroesophageal reflux disease that is not treated with a proton pump inhibitor on a scheduled treatment regimen (not as needed).
    b. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician.
    c. The patient has any of the following medical conditions:
    - Conditions that may mimic asthma (eg, vocal cord dysfunction, hyperventilation, panic attacks, cardiac asthma, uncontrolled gastroesophageal reflux disease [gastroesophageal reflux disease controlled on a stable proton pump inhibitor regimen for at least 1 month may be allowed])
    - Conditions of immunodeficiency, immunocompromise, and/or conditions requiring immunomodulatory therapy
    - A history of malignancy within 5 years before screening (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening)
    - Tested positive for tuberculosis (TB) at screening by the QuantiFERON® TB Gold Test, or had a history of untreated latent or active TB. If the QuantiFERON® TB Gold Test is deemed by the principal investigator to be a false positive, a repeat specimen shall be submitted; if the second test is
    also positive, the patient screen fails; if the second test is negative, a third test shall be submitted; if the third test agrees with the first test, the patient screen fails; if the third test agrees with second test, the patient is considered
    to be negative for TB;
    - Known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening
    - A history of more than one herpes zoster episode or multimetameric herpes zoster
    - A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, aspergillosis, Clostridium difficile)
    - A history of or ongoing chronic or recurrent infectious disease (eg, infected indwelling prosthesis, osteomyelitis, chronic sinusitis)
    - A suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the initial screening visit. Note: Patients who develop an upper respiratory infection/lower respiratory infection (URI/LRI) during the screening period may rescreen 2 weeks after symptoms resolve subject to local or regional public health directives.
    - Patients with clinical symptoms that may indicate COVID-19 infection, and/or patients who in the investigator’s opinion were at high risk of exposure to COVID-19 within 6 weeks before screening or during screening/run-in, will be tested for active COVID-19 infection and will only be included if they test negative for COVID-19.
    For further exclusion criteria see protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of patients who experience loss of asthma control (LoAC) during the treatment period.
    LoAC is defined as any one of the following during the treatment period:
    • Morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second (FEV1) decrease ≥20% from baseline on 2 consecutive days
    • Increase in short-acting beta agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days
    • Increase in ICS dose ≥4x most recent dose
    • Systemic corticosteroid use
    • Asthma ER visit or hospitalization
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients who experience loss of asthma control (LoAC) during the 16 week treatment period
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are as follows:
    • Time from randomization to LoAC during the treatment period
    • Asthma Control Questionnaire 6-question version (ACQ-6) at end-of-treatment (EOT) and throughout the study
    • FEV1 (% predicted, L) at EOT and throughout the study
    • Use of SABA quick relief medication at EOT and throughout the study
    The other efficacy endpoints are as follows:
    • Proportion of patients who have a clinical asthma exacerbation (CAE) during the treatment period
    CAE is defined as a worsening of asthma symptoms resulting in any of the following:
    - The use of systemic corticosteroids (oral or injectable)
    - An emergency department visit due to asthma treated with systemic corticosteroids
    - An inpatient hospitalization due to asthma.
    Note: CAEs are a subset of LoACs
    • Time from randomization to first CAE during the treatment period
    • Number of nighttime awakenings due to asthma during the treatment period
    • Percent decrease in ICS dose during the treatment period
    • Other lung function parameters as assessed by hand-held spirometry at end of treatment (EOT) and throughout the study
    • Fractional exhaled nitric oxide (FeNO) throughout the study
    The safety endpoints for this study are as follows:
    • Frequency of adverse events
    • Change from baseline in clinical laboratory test results (serum chemistry, hematology, and urinalysis) throughout the study
    • Change from baseline in vital signs throughout the study
    • Change from baseline in 12-lead electrocardiogram (ECG) findings throughout the study
    • Use of concomitant medication
    • Local tolerability
    • Number (%) of patients who did not complete the study due to adverse events
    The pharmacokinetic endpoints for this study are as follows:
    • Trough serum TEV-48574 concentrations throughout the study (sparse sampling)
    • Population pharmacokinetic analysis of pharmacokinetic data
    The immunogenicity endpoints for this study are as follows:
    • Assessment of treatment-emergent anti-drug-antibody (ADA) results and responses: change from baseline and throughout the study
    • Impact of the presence of ADAs on pharmacokinetics and clinical safety (if possible)
    • Assessment of neutralizing ADA in ADA positive patients throughout the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 week treatment period
    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 No
    E.6.10Pharmacogenetic No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    United States
    Bulgaria
    Germany
    Poland
    Czechia
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 109
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 124
    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 Decision2021-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-17
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