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    Summary
    EudraCT Number:2018-002242-36
    Sponsor's Protocol Code Number:GB001-2001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-002242-36
    A.3Full title of the trial
    A Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 as maintenance therapy in adult subjects with moderate to severe asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GB001 in adult subjects with moderate to severe asthma
    A.4.1Sponsor's protocol code numberGB001-2001
    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 SponsorGB001, 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 supportGB001, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address929 N.Front Street
    B.5.3.2Town/ cityWilmington, NC
    B.5.3.3Post code28401
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1910558-8218
    B.5.6E-mailpaul.kelly@ppdi.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 GB001
    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.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGB001
    D.3.9.3Other descriptive nameADC3680B
    D.3.9.4EV Substance CodeSUB32366
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Eosinophilic Asthma
    E.1.1.1Medical condition in easily understood language
    moderate to severe asthma
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    E.1.2System Organ Class 100000004855
    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 effect of GB001 compared to placebo on reducing asthma worsening
    E.2.2Secondary objectives of the trial
    • Evaluate the effects of GB001 compared with placebo on a range of clinical endpoints, including change in ACQ-5 score, change in pulmonary function, and time to first asthma worsening event
    • To evaluate the safety and tolerability of GB001 compared with placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    2. Age: ≥ 18 and < 75 years of age at the time of Screening Visit.
    3. Gender: Males or females:
    a. Women of childbearing potential (WOCBP) must use an acceptable method of contraception at least 1 month prior to Screening through 28 days after the last dose of IP.
    4. Weight: at least 40 kg.
    5. Diagnosis of asthma: A diagnosis of asthma by a physician according to Global Initiative for Asthma (GINA) guidelines of at least 12 months prior to Screening.
    6. Inhaled Corticosteroids (ICS) plus additional controller: Subjects with a documented requirement for regular treatment with medium- or high-dose ICS and at least one other controller medication for at least 12 months prior to Visit 1. Subjects must maintain a stable ICS dose regimen during the 4 weeks prior to Visit 1.
    a. Medium dose ICS is defined as an ICS dose equivalent to fluticasone propionate > 250 to 500 mcg/day and high dose is defined as an ICS dose equivalent to flucticasone propionate > 500 mcg/day (for equivalent ICS doses see Appendix 10, Section 10.10)
    b. An additional controlled medication such as LABA, long-acting muscarinic antagonist (LAMA), or leukotriene receptor antagonist (LTRA).
    7. Forced Expiratory Volume 1 (FEV1): a pre-bronchodilator FEV1 of ≤ 85% of predicted normal.
    8. Reversibility/Airway Hyperresponsiveness: of at least 12% in FEV1 following 4 puffs of albuterol 400 µg ex-US (360µg US) or 1 equivalent nebulized dose/salbutamol 100 mcg at Screening. Reversibility is to be assessed in all subjects at Screening.
    • If a subject does not reverse at least 12% at Screening, the site may submit historical documentation of one of the following for review and approval by the medical monitor:
    - reversibility in the 24 months prior to Screening visit, OR
    - airway hyperresponsiveness demonstrated by a positive methacholine, histamine, or mannitol challenge
    9. Evidence of uncontrolled asthma: demonstration of uncontrolled asthma by one of the following:
    a. Previously confirmed history of 2 or more asthma exacerbations requiring treatment with systemic corticosteroids in the 12 months prior to Screening Visit.
    OR
    b. Previously confirmed history of 1 asthma exacerbation requiring treatment with systemic corticosteroids in the 12 months prior to Screening Visit and Asthma Control Questionnaire-5 (ACQ-5) of ≥ 1.5 at Screening Visit.
    10. Are willing and able to comply with the requirements for participation in the study.
    E.4Principal exclusion criteria
    1. Smoking history: Current smokers (any substance), or former smokers with a smoking history of ≥ 10 pack-years [(number of cigarettes per day/20) x number of years smoked]. A former smoker is defined as a subject who quit smoking at least 6 months prior to Screening Visit. This includes electronic cigarettes and vaping.
    2. Concurrent Respiratory Disease: Presence of a known pre-existing clinically important lung condition other than asthma. This includes current infection, active tuberculosis infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
    3. Malignancy: A current malignancy or previous history of cancer in remission for less than 5 years prior to Screening. (Subjects will not be excluded if they had localized carcinoma of the skin that was resected for cure.)
    4.Liver Disease: Known pre-existing liver disorders (ie, non-alcoholic fatty liver disease (NALFD) or Gilbert's syndrome), or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice), cirrhosis, or known biliary abnormalities.
    5. Other Concurrent Medical Conditions: Known, pre-existing clinically significant endocrine, autoimmune, metabolic, neurological, renal (calculated creatinine clearance < 60 mL/min), gastrointestinal, hepatic, cardiovascular, hematological, or any other system abnormalities that are uncontrolled with standard treatment.
    6. Eosinophilic Disease: Subjects with any other condition that could lead to elevated eosinophils such as hypereosinophilic syndrome, including eosinophilic granulomatosis with polyangiitis.
    7. Electrocardiogram (ECG) Assessment: QTcF (Fridericia's correction formula for QT interval (interval between Q wave and T wave) ≥ 450 msec for males or QTcF ≥ 470 msec for females at the Screening Visit. If QTcF is above the prespecified limit and there are no other clinically abnormalities, the assessment can be repeated in triplicate and the three results will be averaged for eligibility.
    8. Alcohol/Substance Abuse: A history or suspected history of alcohol misuse or substance abuse, including marijuana, within 12 months prior to Screening Visit.
    9. Immunodeficiency: A known immunodeficiency, including that due to human immunodeficiency virus (HIV), other than that explained by systemic corticosteroid use.
    10. Investigational medications: Subjects who have received treatment with an investigational medication within the past 30 days or within 5 half-lives of the medication, whichever is longer, prior to Screening Visit. (This also includes investigational formulations of marketed products.)
    11. Prostaglanding D2 Receptor (DP2) (CRTh2 - chemoattractant receptor-homologous molecule expressed on Th2) antagonist studies: Participated in another DP2 (CRTh2) antagonist study in the 12 months prior to Screening Visit or known prior intolerance or inadequate response in a prior DP2 antagonist study.
    12. Receiving prohibited medications or treatments:
    a. Regular use of systemic corticosteroids or immunosuppressive therapies including methotrexate or azathioprine
    b. Monoclonal antibodies used in the treatment of asthma such as reslizumab, mepolizumab, omalizumab or benralizumab
    c. Medications, food or drink that are moderate or strong CYP3A4 (Cytochrome P450 3A4) inhibitors or inducers
    d. Medications that have the potential for interaction with GB001
    e. Bronchial thermoplasty and radiotherapy are excluded in the 12 months prior to Screening
    13. Prior participation in a study with GB001: Subjects who previously participated in a study with GB001 (also named PTR-36 or ADC3680) are not eligible for this study.
    14. Hypersensitivity: A known sensitivity to GB001 or any of its excipients. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption are not eligible for this study. Subjects with mild moderate lactose intolerance are not excluded.
    15. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they are planning to become pregnant during the time of study participation. A serum pregnancy test is required of all females of child-bearing potential at Screening.
    16. Adherence: Subjects who have a known lack of adherence to controller medications.
    17. Body Mass Index (BMI): BMI is ≥ 40 kg/m2.
    18. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study, including participation in another clinical trial while participating in this study.
    E.5 End points
    E.5.1Primary end point(s)
    1. To evaluate the effect of GB001 compared to placebo on reducing asthma worsening -The proportion of subjects who experience worsening of asthma by Week 24 as defined by at least one of the following:
    -On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in
    -Forced expiratory volume in 1 second (FEV1) < 80% of baseline (Visit 2)
    -Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in
    -Increase in Asthma Control Questionnaire (ACQ 5) score of ≥ 0.5 compared to baseline (Visit 2)
    -The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 24
    E.5.2Secondary end point(s)
    1. To evaluate the effects of GB001 compared with placebo on a range of clinical endpoints, including change in ACQ-5 score, change in pulmonary function, and time to first asthma worsening eventChange from baseline to Week 24 in ACQ-5 score
    - Change from baseline to Week 24 in pre bronchodilator FEV1
    - Time to first asthma worsening
    - Annualized rate of severe asthma exacerbations
    - Change from baseline to Week 24 in post bronchodilator FEV1
    - Change from baseline to Week 24 in AM PEF

    2. To evaluate the safety and tolerability of GB001 compared with placebo
    - Incidence of treatment-emergent adverse events (TEAEs)
    - Change from baseline in laboratory, vital signs, and electrocardiogram (ECG) parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 24

    2. Screening period and weeks 0, 2, 4, 8, 12, 16, 20, 24, early termination visit, week 28
    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 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 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 trial4
    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 EEA56
    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
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Poland
    Spain
    Ukraine
    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
    Subjects will be regarded to have completed the study if he/she completes the Week 24 visit. The end of the study is defined as the date of the last visit of the last subject in the study.
    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 months1
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 415
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 480
    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)
    Subjects who complete the study and meet the eligibility criteria for the Extension Study (ES) will be offered the opportunity to receive active treatment in the ES when the study is available.
    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 Decision2019-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-18
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