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    Summary
    EudraCT Number:2018-003093-27
    Sponsor's Protocol Code Number:GB002-1101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-12
    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 number2018-003093-27
    A.3Full title of the trial
    A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study of Inhaled GB002 for the Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH)
    A.3.2Name or abbreviated title of the trial where available
    GB002 in Adult Subjects with PAH
    A.4.1Sponsor's protocol code numberGB002-1101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03926793
    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 SponsorGB002, 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 supportGB002, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGB002, Inc
    B.5.2Functional name of contact pointClinical Trials Information Website
    B.5.3 Address:
    B.5.3.1Street Address3013 Science Park Road, Suite 200
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.6E-mailClinicalTrials@gossamerbio.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 nameGB002 Capsules
    D.3.2Product code GB002
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGB002
    D.3.9.1CAS number 1619931-27-9
    D.3.9.2Current sponsor codeGB002
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9 to 15
    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 Yes
    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 placeboInhalation powder, hard capsule
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Arterial Hypertension (PAH)
    E.1.1.1Medical condition in easily understood language
    WHO Group 1 pulmonary arterial hypertension is associated with raised blood pressure in the pulmonary artery due to abnormalities in the small branches of the pulmonary artery, the arterioles
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077739
    E.1.2Term Pulmonary arterial hypertension WHO functional class I
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Study:
    To evaluate the safety and tolerability of orally inhaled GB002 in subjects with WHO Grade 1 PAH.

    Open-Label Extension (OLE) Study:
    To evaluate the long-term safety and tolerability of orally inhaled GB002 in subjects with WHO Group 1 PAH who have completed the Main Study.
    E.2.2Secondary objectives of the trial
    Main Study:
    To evaluate PK of orally inhaled GB002.

    Open-Label Extension (OLE) Study:
    Evaluate the long-term effect of orally inhaled GB002 on exercise capacity, functional class, NT-proBNP, cardiac function and quality of life in subjects with WHO Group 1 PAH who have completed the Main Study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Study
    1 Evidence of a personally signed and dated informed consent document indicating the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures. Willingness & ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    2 Adult (males & females) aged 18-75 years (incl) with WHO Gp 1 PAH
    3 A current diagnosis of symptomatic PAH classified by one of the following:
    a Idiopathic or heritable PAH
    b PAH associated with one of the following connective tissue diseases:
    i Systemic sclerosis
    ii Rheumatoid arthritis
    iii Mixed CTD or overlap syndrome
    iv Systemic lupus erythematosus
    c PAH associated with anorexigen or methamphetamine use
    4 A WHO/NYHA functional class II–IV symptomatology
    5 Documentation of right heart catheterization prior to screening consistent with the diagnosis of PAH and meeting all following criteria:
    a Mean pulmonary arterial pressure (mPAP) ≥25 mmHg (at rest)
    b Pulmonary capillary wedge pressure (PCWP) ≤15 mmHg, or mean left atrial pressure (mLAP) or left ventricular-end diastolic pressure (LVEDP) ≤15 mmHg in the absence of left atrial obstruction
    c Pulmonary vascular resistance (PVR) ≥4 mmHg/L/min or 320 dyn×sec/cm5
    A qualifying cardiac catheterization is required during screening period if results of previous assessments are not documented
    6 Treatment with single or combination therapy from classes of phosphodiesterase type 5 (PDE-V) inhibitors, guanylate cyclase (GC) stimulators, endothelin receptor antagonists, and prostanoids including prostacyclins and small molecule prostacyclin receptor agonists, eg, selexipag (with exception of inhaled prostanoids) is allowed. For this study, single or combination therapy with one or more of these drugs is considered PAH background therapy. Subjects who are intolerant of all PAH background therapy may be allowed to be randomized on a case-by-case basis in consultation with the Medical Monitor. PAH background medications should remain stable and unchanged for the past 30 days prior to screening. In addition, diuretic doses should be stable for the past 30 days prior to Screening. Diuretics (as needed) for intermittent weight gain (if prescribed 30 or more days prior to screening and unchanged within 30 days prior to Screening) will be considered a stable dose for this study.
    7 Pulmonary function tests (PFTs) and diffusing capacity of the lungs for carbon monoxide (DLCO) at screening with the following criteria met:
    a Forced expiratory volume in 1 second (FEV1) ≥70% (predicted)
    b FEV1/forced vital capacity ratio (FEV1/FVC) >70%
    c DLCO ≥40% predicted except for subject with PAH associated with systemic sclerosis (SSc-APAH) where DLCO ≥30% is required
    If the subject uses continuous oxygen therapy, they must be able to complete PFTs without oxygen. Subjects who are unable to complete PFTs without oxygen therapy are not eligible for study
    8 Body weight >40 kg at screening
    9 6 Minute Walk Test (6MWT) distance >100 m at screening; if distance walked is not >100 m, test may be repeated once; the distance walked during second assessment must be >100 m, with test conducted on a separate day)
    10 No evidence of CTEPH or acute pulmonary embolism as assessed by ventilation-perfusion (V/Q) lung scan, CT-angiogram, or pulmonary angiogram (i.e., should note “normal” or “low probability” for pulmonary embolism) prior to screening, or at screening if: a) not performed prior or b) if clinical course suggests possibility of a pulmonary embolus as determined by the principal investigator since the last time study was performed
    11 Women of childbearing potential must use one contraceptive method (one additional non hormonal contraceptive method if using combined hormonal contraceptive or progestogen-only hormonal contraceptive) that is highly effective (failure rate of <1% per year), preferably with low user dependency during the intervention period and for at least 28 days after the last dose of IP, and have a negative pregnancy test at Screening and Day 1. To be considered as “not of childbearing potential” females must be either: postmenopausal for at least 1 year as confirmed by an elevated FSH level (≥30 mIU/mL) at Screening and 1 year of amenorrhea OR have been irreversibly surgically sterilized by hysterectomy, oophorectomy, or bilateral tubal ligation at least 3 months prior to the first dose of IP. Men who are not sterile (ie, have not had a vasectomy) must also agree to use contraception and not donate sperm during the intervention period through at least 3 months after the last dose of IP

    OLE Study (abbrv.)
    1 Adult female subjects aged 18-75 years, inclusive, or adult male subjects aged 50-75 years, inclusive.
    2 Willing to Comply with Protocol/Informed Consent Signed
    3 Prior study completion
    4 Contraception
    For subjects with gap ≥1 day between the Main study and OLE
    5 PAH Diagnosis
    6 Background PAH therapy
    E.4Principal exclusion criteria
    Main Study
    1 Participation in a device or other interventional clinical study within 1 month (30 days; or within 5 half-lives of the medication, whichever is longer) of Day 1
    2 Clinically significant systemic hypertension or hypotension
    3 History of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
    a Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild aortic insufficiency, mild aortic stenosis (AS), mild mitral stenosis (MS), moderate mitral regurgitation (MR)
    b.Mechanical or bioprosthetic cardiac valve
    c Pericardial constriction or pericardial effusion with tamponade physiology
    d Restrictive or congestive cardiomyopathy
    e Left ventricular ejection fraction (LVEF) ≤50% ECHO performed within 84 days prior to Screening will be accepted with availability of results documentation. If ECHO results within 84 days prior to Sceening are not available, then ECHO will be performed as part of Sceening
    f Symptomatic coronary disease
    g Significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation
    h Acutely decompensated left heart failure within 1 month (30 days) of screening
    i History of untreated obstructive sleep apnea
    4 History of Atrial Septostomy
    5 History of decompensated right heart failure within 30 days of screening (e.g., hospitalization for PAH or the need to add an additional PAH medication)
    6 Use of inhaled prostanoids
    7 Moderate to severe hepatic impairment classified as a Child-Pugh Class B or C at screening
    8 An estimated glomerular filtration rate (eGFR) < 45 mL/min via CKD-epi at Screening or requires chronic renal replacement therapy for any cause
    9 Requirement of intravenous (IV) inotropes (eg levosimendan, dopamine, dobutamine, milrinone; norepinephrine) other than a prostanoid within 1 month (30 days) of screening
    10 A positive result for hepatitis B or C infection indicating prior infection (excluding hepatitis B antibody due to prior vaccination), human immunodeficiency virus (HIV) antibody, or tuberculosis (TB)
    11 Pulmonary venous occlusive disease
    12 Anemia: Hgb concentration <8.5 g/dL at Screening
    13 Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study; including but not necessarily limited to the following: malignancy within 5 years of Screening, with the exception of effectively treated or excised localized non-metastatic basal cell carcinoma of the skin and in situ carcinoma of the cervix; psychiatric disorder that compromises ability to give informed consent, substance abuse; history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage; thyroid disease requiring treatment, gastrointestinal (GI) bleed requiring blood transfusion, history of pulmonary embolus or deep vein thrombosis (DVT), history of vasovagal syncope with phlebotomy
    14 Currently pregnant or breastfeeding or intends to become pregnant during the duration of the study
    15 Atrial fibrillation (AFIB), atrial flutter, or history of AFIB/flutter within 1 year prior to Screening. History of a potentially life-threatening cardiac arrhythmia; prior ablation for AFIB/atrial flutter
    16 Use of anticoagulants (i.e.coumadin or novel oral anticoagulant [NOAC]); if on coumadin or a NOAC it is clinically acceptable to be withdrawn 1 month prior to start of IP.
    17 Any over-the-counter (OTC) medication use specifically including acetaminophen (up to 2 g per day, not to exceed 4g per week during the 14 days prior to administration of the first dose of GB002) will be allowed
    18 Inability to perform maneuvers required for adequate inhalation using a dry powder inhaler (DPI) after instruction
    19 Inability to generate a flow rate of at least 60 L/min with an inhalation testing device after instruction at screening
    20 Prior treatment with a kinase inhibitor
    21 Use of inhaled Tobacco or Marijuana
    22 A positive test for drugs of abuse (amphetamines, methamphetamines, barbiturates, cocaine, phencyclidine [PCP], methadone, and opioids [narcotics]) or cotinine. Retest may be performed for potential false positive results with approval from the medical monitor

    OLE Study (abbrv.)
    1 Male subjects <50 years of age
    2 Other Clinical Study Participation
    3 Any other condition or any other reason
    4 Systemic Hypertension or Hypotension
    5 Left Heart Disease
    6 Atrial septostomy
    7 Hepatic Impairment
    8 Renal Impairment
    9 Anemia
    10 Malignancy
    11 Pregnancy
    12 Cardiac Arrythmia
    13 Anticoagulation
    14 IV Inotropes
    15 Other Medical or Lab Abnormality
    16 Inhaled Tobacco or Marijuana
    17 Drugs of Abuse
    E.5 End points
    E.5.1Primary end point(s)
    Main Study
    The incidence of adverse events (AEs) and changes from baseline in oxygenation, pulmonary function, clinical laboratory parameters, electrocardiogram (ECG) parameters, vital sign parameters, and assessment of cardiac function by echocardiogram (ECHO).

    OLE Study
    Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs (SAEs).
    Changes from baseline in clinical laboratory parameters, ECG parameters, pulmonary function, and vital signs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Main Study
    Adverse events: from Day 1 to Day 42
    EKG, pulmonary function and clinical laboratory parameters: screening; treatment period Day 1, 8, 14; early withdrawal visit
    Assessment of left ventricular ejection fraction (LVEF) by cardiac MRI: screening; treatment period Day 14; early withdrawal visit

    OLE Study
    Every 4 weeks (Study days 29, 57, 85, 113, 141 and 169); early withdrawal visit.
    E.5.2Secondary end point(s)
    Main Study
    The PK parameters of GB002 and metabolite(s), if applicable.

    Open Label Extension (OLE) Study
    Changes from baseline in:
    − Six minute walk test (6MWT)
    − WHO Functional class (FC)
    − NT-proBNP
    − Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) quality of life (QOL) questionnaire

    Changes from baseline in right ventricular (RV) function by ECHO
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main Study
    Treatment period Day 1, 2, 8, 14.

    OLE Study
    Every 4 weeks (Study days 29, 57, 85, 113, 41 and 169); early withdrawal visit.
    ECHO at Day 85 only and early withdrawal visit.
    NT-proBNP collected pre-dose.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Main Study
    Tolerability

    Open-Label Extension (OLE) Study
    The multi-center, OLE study investigates the long-term safety, tolerability, and efficacy of orally inhaled GB002 after extended dosing of up to 24 weeks in subjects with WHO Group 1 PAH who previously completed the Main study.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase Ib
    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 Yes
    E.8.1.7.1Other trial design description
    2 Cohorts
    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 concerned3
    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 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
    Denmark
    France
    Netherlands
    Sweden
    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
    The End of Study is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary, and/or exploratory analysis, whichever occurs later.
    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 months0
    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 months2
    E.8.9.2In all countries concerned by the trial days14
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 16
    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)
    The Investigator should resume standard of care treatment, including treatment with appropriate medications, as deemed necessary.
    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 Decision2019-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-16
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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