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    Summary
    EudraCT Number:2018-000378-30
    Sponsor's Protocol Code Number:SMR-3372
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-05
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2018-000378-30
    A.3Full title of the trial
    A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A dose finding study of OligoG in patients with CF.
    A.4.1Sponsor's protocol code numberSMR-3372
    A.5.4Other Identifiers
    Name:H2020Number:755234
    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 SponsorAlgiPharma AS
    B.1.3.4CountryNorway
    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 supportH2020
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportAlgiPharma AS
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMERUD Medical Research
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressO7,1
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68161
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962117028490
    B.5.5Fax number+49621170284928
    B.5.6E-mailhans.mueller@smerud.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/475
    D.3 Description of the IMP
    D.3.1Product nameOligoG CF-5/20
    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 INNOLIGOG CF-5/20
    D.3.9.3Other descriptive nameOLIGOG CF-5/20
    D.3.9.4EV Substance CodeSUB130807
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number17.5
    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 Yes
    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.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/475
    D.3 Description of the IMP
    D.3.1Product nameOligoG CF-5/20
    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 INNOLIGOG CF-5/20
    D.3.9.3Other descriptive nameOLIGOG CF-5/20
    D.3.9.4EV Substance CodeSUB130807
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27.5
    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 Yes
    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.IMP: 3
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/475
    D.3 Description of the IMP
    D.3.1Product nameOligoG CF-5/20
    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 INNOLIGOG CF-5/20
    D.3.9.3Other descriptive nameOLIGOG CF-5/20
    D.3.9.4EV Substance CodeSUB130807
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    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 Yes
    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
    Cystic Fibrosis
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    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 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To identify the most efficacious dose of OligoG as defined by the relative change in % Forced Expiratory Volume in one second (FEV1) after 12 weeks. The safety of this dose will also be assessed; the dose with the highest efficacy and most favourable safety profile will be selected for part 2.
    • To determine the efficacy of the dose of OligoG selected in part one after 26 weeks of treatment.
    E.2.2Secondary objectives of the trial
    • To compare the safety profiles of OligoG and placebo in patients with CF during 6 months (26 weeks) treatment.
    • To document the long term safety of OligoG during 12 months (52 weeks) treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Confirmed diagnosis of Cystic Fibrosis (CF) defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis or genotypic confirmation of CFTR mutation.
    • Age 12 years or older.
    • Male or female patients with any ethnicity.
    • FEV1 at screening in the range of ≥40% and ≤ 90% of the predicted normal for age, sex, and height, according to the GLI equation (Eur Respir J. Dec 2012; 40(6): 1324–1343).
    • A documented history of chronic Pseudomonas aeruginosa (PA)
    infection
    • History of antibiotic treatment due to PA infection (not for eradication therapy) during the last 12 months
    • Concomitant treatment with inhaled tobramycin, colistin, aztreonam or levofloxacin (either cycled or continuous) for at least 3 months at screening to treat PA infection. In case of cycled inhaled antibiotic treatment, randomisation should be done at the start of a new cycle +/- 2 days.
    (together with the IMP intake).days.
    • Stable CF disease as judged by the investigator.
    • Willing to remain on a stable CF medication regimen (standard of care; SOC) during the study.
    • Women of child-bearing potential must have a negative serum pregnancy test at the Screening and Randomisation Visit.
    • Male and female patients must use acceptable contraceptive methods for the duration of the study. Male and female patients without child-bearing potential (i.e. who are infertile, surgically sterile or post-menopausal) are exempted from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as one or a combination of the following:
    o oral, injected, transdermal or implanted hormonal methods of contraception;
    o placement of an intrauterine device (IUD) or intrauterine system (IUS);
    o barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    • Capable of inhaling dry powder.
    • Willing to sign informed consent (in adolescent patients: parent(s) or legal guardian(s) must be willing to sign the consent form according to the national regulatory requirements and the adolescent patients must be willing to sign the assent form.
    • Willing and able to follow the study procedures.
    E.4Principal exclusion criteria
    • Use of hypertonic saline more than 2 times a day. If hypertonic saline is used, IMP inhalation should be taken 15 minutes after completion of hypertonic saline therapy.
    • Use of CFTR modulator therapies.
    • Clinically significant abnormal findings or any value > 3x the upper normal limit of haematology or clinical chemistry parameters, except for the inflammation marker C-reactive protein (CRP), as CRP is standardly increased in CF patients. Further exceptions may be allowed in the case of elevated gamma-GT (GGT) values, exceeding this threshold. These GGT cases will be carefully scrutinised alongside other clinical and laboratory data. Following discussion between the medical monitor and the principal investigator to exclude significant liver injury, the subject may be enrolled in the study.
    • History of any comorbidity that, in the opinion of the investigator, might distort the results of the study or cause an additional risk in administering study drug to the patient.
    • Pulmonary exacerbation within 28 days prior to randomisation.
    • Change in CF therapy within 28 days before randomisation (first dose of IMP).
    • Pregnant or breastfeeding females.
    • Hypersensitivity (allergic reaction of any grade) to the IMP or to any of the excipients or placebo.
    • Patients unable to perform pulmonary function tests according to the ATS/ERS criteria.
    • Uncontrolled or unstable acute or chronic diseases (e.g. congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations) that would limit the compliance with study requirements in the opinion of the investigator.
    • History of, or planned organ transplantation.
    • Lung infection with Burkholderia cepacia complex or Mycobacterium abscessus.
    For subjects who have had a history of a positive culture, the following criteria will be used to determine whether the subject is free of infection with such organisms:
    a) The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent, and
    b)The subject has had at least 2 respiratory tract cultures negative for such organisms within the 12 months before the date of informed consent, with the first and last of these separated by at least 3 months, and the most recent one within the 6 months before the date of informed consent.
    • Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to the Screening Visit, defined as having received pharmacological treatment for ABPA.
    • Requirement for continuous (24 hour/day) oxygen supplementation.
    • Patients currently receiving any other investigational treatment, or who have participated in a clinical study within 4 weeks (28 days) prior to the screening visit.
    • Current malignant disease (with the exception of basal cell carcinoma and cervical neoplasia).
    • Any medical condition, other than CF, which in the opinion of the investigator exposes the patient to an unacceptably high risk.
    • Patients with documented or suspected, clinically significant, alcohol or drug abuse as per Investigator’s discretion.
    E.5 End points
    E.5.1Primary end point(s)
    Relative change in FEV1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: Baseline to 12 weeks of treatment
    Part 2: Baseline to 26 weeks of treatment
    E.5.2Secondary end point(s)
    - Absolute change in % predicted FEV1
    - Forced Vital Capacity (FVC), Mean Forced Expiratory Flow between 25% and 75% (FEF25-75) of FVC, Peak Expiratory Flow (PEF)
    - Rate of Pulmonary Exacerbations
    - Culture microbiology including Pseudomonas aeruginosa density in expectorated sputum
    - Sputum rheology
    - Quality of Life (CFQ-R)
    - Patient drug compliance
    - Lung Clearance Index (LCI)
    - BMI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and end of treatment
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 180
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 168
    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 be treated after the trial has been ended with the medical standard therapy according to 4.3 GCP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ECFS CTN
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-02-15
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