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    Summary
    EudraCT Number:2019-001682-33
    Sponsor's Protocol Code Number:GB001-2101
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-001682-33
    A.3Full title of the trial
    A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of GB001 in patients with chronic rhinosinusitis with or without nasal polyps
    Multicentrická randomizovaná dvojitě zaslepená klinická studie fáze 2a kontrolovaná placebem hodnotící účinnost přípravku GB001 u pacientů s chronickou rinosinusitidou s nosními polypy nebo bez nich
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GB001 in Adult Subjects with Chronic Rhinosinusitis
    A.4.1Sponsor's protocol code numberGB001-2101
    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 organisationPSI CRO AG
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressBaarerstrasse 113a
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+38044492 85 60
    B.5.6E-mailillia.atamanchuk@psi-cro.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
    Chronic Rhinosinusitis with or without Nasal Polyps
    E.1.1.1Medical condition in easily understood language
    Chronic Rhinosinusitis
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10071399
    E.1.2Term Chronic eosinophilic rhinosinusitis
    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
    • To evaluate the effect of GB001 on the Sino-Nasal Outcome Test-22 (SNOT-22)
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of GB001 on reducing opacification of the sinuses as measured by CT scan
    • To evaluate the effect of GB001 in the treatment of bilateral NP by assessment of the endoscopic nasal polyp score (NPS) in a subset of patients with nasal polyps
    • To evaluate the effect of GB001 in improving patient reported symptoms
    • To evaluate the effect of GB001 in improving sense of smell (University of Pennsylvania Smell Identification Test, UPSIT)
    • To evaluate the effect of GB001 on chronic rhinosinusitis (CRS) exacerbation
    • 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 to 75 years of age at the time of Screening visit.
    3. Sex: 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. Diagnosis: Diagnosis of chronic rhinosinusitis with or without bilateral nasal polyps for at least 12 weeks prior to Visit 1.
    5. Nasal symptoms: Presence of at least two of the following symptoms prior to Visit 1:
    • nasal blockade/obstruction/congestion
    • nasal discharge (anterior/posterior nasal drip)
    • facial pain/pressure
    • preduction or loss of smell
    6. INCS: Subjects must be on a stable administration of intranasal corticosteroids (INCS) for ≥ 2 months prior to Visit 1. For subjects using a specialized delivery device (eg, XHANCE™) or corticosteroids administered via irrigation (eg, budesonide + sterile saline), they must be on MFNS for ≥ 2 weeks prior to screening.
    E.4Principal exclusion criteria
    1.Nasal symptoms: SNOT-22 score <20 as assessed at screening. 2.Prior polyp surgery: Subjects who have undergone any nasal surgery (excluding polypectomy performed as an outpatient procedure) within 4 months before screening or have had ≥4 sinonasal surgeries in the past. 3.Comorbidities: Presence of a known pre-existing clinically important condition including: active tuberculosis, pulmonary fibrosis, bronchopulmonary aspergillosis, eosinophilic granulomatous polyangiitis (Churg-Strauss syndrome), Young's syndrome, Kartagener's syndrome or dyskinetic ciliary syndromes, and cystic fibrosis.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. 4.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). 5.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. 6.Prior anti-inflammatory treatment: Subjects who have required a burst of systemic corticosteroids (eg, oral, intravenous, intramuscular corticosteroids) within the 1 month before screening or are scheduled to receive systemic corticosteroids during the study period for another condition, or who have required intranasal corticosteroid drops within 1 month prior to screening.
    7.Intolerant to mometasone furoate nasal spray. 8.Specific conditions/concomitant diseases: Subjects with conditions such as: antrochoanal polyps, nasal septal deviation that would occlude at least one nostril; acute sinusitis, invasive fungal rhinosinusitis, neutrophilic polyposis, nasal infection or upper respiratory infection at screening or in the 2 weeks before screening. Subjects requiring chronic systemic antibiotic treatment for rhinosinusitis. 9.Ongoing rhinitis medicamentosa. 10.ECG Assessment: Subjects with QTcF ≥450 msec for males or QTcF ≥470 msec for females on the Screening visit ECG. However, if QTcF is above this prespecified limit and there are no other clinically significant ECG abnormalities in the opinion of the Investigator, the assessment can be repeated in triplicate. The triplicate QTcF values should be averaged by the Investigator to determine eligibility of the subject to enter the Run-in period. However, if any of the triplicate ECGs show a clinically significant abnormality in the opinion of the Investigator, the subject should be excluded, regardless of the average QTcF of the triplicates. 11.Alcohol/Marijuana/Illicit Drugs/Substance Abuse: A known or suspected history of alcohol misuse, marijuana, illicit drugs, or substance abuse within 12 months prior to Screening visit. 12.Smoking history: Asthma or COPD patients that are current smokers (any substance), or former smokers with a smoking history of ≥10 pack-years [(number of cigarettes per day/20) × 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. 13.Immunodeficiency: A known immunodeficiency, including that due to human immunodeficiency virus (HIV), other than that explained by systemic corticosteroid use. 14.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). 15.Receiving prohibited medications: Refer to Appendix 10 (Section 10.10) for more details. a. Regular use of systemic corticosteroids or immunosuppressive therapies including methotrexate or azathioprine b. Monoclonal antibodies used in the treatment of asthma c. Medications, food or drink that are moderate or strong CYP3A4 inhibitors or inducers d. Other medications that have the potential for interaction with GB001 e. Medications that have a black-box warning for hepatic toxicity. 16.Prior participation in a study with GB001: Subjects who previously participated in a study with GB001 (also named PTR-36 or ADC3680). 17.Hypersensitivity: A known sensitivity to GB001 or any of its excipients. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. Subjects with mild-moderate lactose intolerance are not excluded. Subjects with sensitivity or intolerance to aspirin (ie, subjects with aspirin-exacerbated respiratory disease [AERD] with or without desensitization). 18....(see protocol)
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline to Week 16 in SNOT-22
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16

    E.5.2Secondary end point(s)
    • Change from baseline to Week 16 in opacification of sinuses as measured by Lund-Mackay score on CT scan
    • Change from baseline to Week 16 in NPS
    • Time to first response (≥ 1 point improvement from baseline) in NPS
    • Change from baseline to Week 16 in nasal congestion (NC)
    • Change from baseline to Week 16 in total symptom score (TSS)
    • Change from baseline to Week 16 in UPSIT
    • Time to first CRS exacerbation, defined as deterioration of CRS symptoms requiring treatment with an antibiotic, an anti-inflammatory drug, or a symptom reliever; an Emergency Department visit; or hospitalization
    • Incidence of treatment-emergent adverse events (TEAEs)
    • Change from baseline in laboratory, electrocardiogram (ECG), and vital signs parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 16
    2. Screening period and weeks 0, 2, 4, 8, 12, 16, Early Withdrawal from Study, Early Discontinuation of IP, week 20
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Czech Republic
    Ukraine
    United States
    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
    Subjects will be regarded to have completed the study if he/she completes the Week 16 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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days20
    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 days20
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 100
    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 will be regarded to have completed the study if he/she completes the Week 16 visit. The end of the study is defined as the date of the last visit of the last subject in the study.
    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 Decision2019-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-05
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