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    Summary
    EudraCT Number:2018-001725-75
    Sponsor's Protocol Code Number:2015-DFU-301
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-01-08
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-001725-75
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Parallel-group, Vehicle controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Study of the Efficacy and Safety of Granexin Gel in the
    Treatment of Diabetic Foot Ulcer (GAIT 1)
    A.3.2Name or abbreviated title of the trial where available
    GAIT 1
    A.4.1Sponsor's protocol code number2015-DFU-301
    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 SponsorFirstString Research, 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 supportFirstString Research, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiTrial Clinical Research
    B.5.2Functional name of contact pointJános Bíró
    B.5.3 Address:
    B.5.3.1Street AddressTállya utca 23.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1121
    B.5.3.4CountryHungary
    B.5.4Telephone number+3618008036
    B.5.5Fax number+3618008037
    B.5.6E-mailjanos.biro@bitrial.hu
    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 nameGranexin® gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaCT1 peptide
    D.3.9.3Other descriptive nameaCT1 peptide
    D.3.10 Strength
    D.3.10.1Concentration unit µmole/ml micromole(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 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 Yes
    D.3.11.13.1Other medicinal product typemethylparaben, propylparaben, glycerin, sodium phosphate monobasic and dibasic, propylene glycol, edetate disodium, D-mannitol hydroxyethyl cellulose, purified water. Granexin contains aCT1 peptide
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameVehicle gel
    D.3.2Product code Vehicle gel - NA
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typemethylparaben, propylparaben, glycerin, sodium phosphate monobasic and dibasic, propylene glycol, edetate disodium, D-mannitol hydroxyethyl cellulose, purified water. Vehicle doesn't contain aCT1
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Foot Ulcer
    E.1.1.1Medical condition in easily understood language
    Diabetic Foot Ulcer
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    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 efficacy of Granexin gel plus standard-of-care in the
    treatment of diabetic foot ulcer, as compared with vehicle gel plus
    standard-of-care and with standard-of-care treatment alone, as
    measured by investigator assessment of wound closure and by other methods
    E.2.2Secondary objectives of the trial
    To evaluate the safety of Granexin gel plus standard-of-care in the
    treatment of diabetic foot ulcer, as compared with vehicle gel plus
    standard-of-care and with standard-of-care treatment alone, by
    standard methods and immunogenicity testing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older
    2. Established diagnosis of diabetes mellitus (type I or II)
    3. Glycosylated hemoglobin (HbA1c) value < 12.0% at the screening visit
    4. Diagnosis of neuropathic foot ulcer by 10 g monofilament test, tuning fork (128 Hz), or cotton wisp
    5. Designated foot ulcer meets the following criteria at both the screening and baseline visits:
    a. Present for at least 4 weeks
    b. Full-thickness cutaneous ulcer below the ankle surface
    c. University of Texas grade A1
    d. Wound area (after debridement) 1 to 40.0 cm2
    e. Viable, granulating wound (investigator discretion)
    6. Ankle brachial index ≥ 0.7 at both the screening and baseline visits. If the ABI is > 1.30, one of the following confirmatory tests must be performed for the patient to be considered eligible:
    a. Does not have a monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, as determined by standard practices of the investigator and the site.
    b. Transcutaneous oxygen pressure (TcPO2) at the foot >40 mmHg
    7. Signed informed consent
    8. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence throughout until 2 weeks after the last administration of investigational product. Male patients must also agree to use contraception such as a condom.
    E.4Principal exclusion criteria
    1. Change (decrease or increase) in size of the designated target ulcer by ≥ 30% during the 7-day screening period
    2. Cannot tolerate off-loading methods or cannot comply with study related procedures
    3. Has an ulcer that meets any of the following criteria:
    a. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site
    b. Requires surgical debridement
    c. Is positive for β-hemolytic streptococci upon culture performed prior to screening debridement procedure.
    d. Has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure
    e. Is highly exuding (i.e., requires daily change of dressing)
    4. Requires total contact cast
    5. Ankle brachial pressure index < 0.7
    6. Has a local or systemic infection or local lymphangitis ≥ 0.5 cm
    7. Has any 1 of the following (only 1 of the 2 tests is required):
    a. A monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries
    b. Transcutaneous oxygen pressure (TcPO2) at the foot < 40 mmHg
    8. Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator’s discretion)
    9. Congestive heart failure (New York Heart Association class II–IV)
    10. Coronary heart disease with ST segment elevation myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the last 6 months
    11. Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI
    12. Active connective tissue disease
    13. Acute or chronic Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination
    14. Active treatment with systemic corticosteroids or topical corticosteroids (for treatment of the target ulcer or any area of the foot). This does not include inhaled corticosteroids or topical corticosteroids used for conditions other than treating the target ulcer or any area of the foot. (Wash out period for systemic corticosteroids is 14 days for inclusion in the study. Wash out period for topical corticosteroids (for treatment of the target ulcer or any area of the foot) is 14 days for inclusion in the study)
    15. Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for inclusion in the study)
    16. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
    17. Pregnant or nursing mothers
    18. Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males)
    19. Estimated glomerular filtration rate < 25 mL/min
    20. Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl)
    21. Significant peripheral edema as per investigator’s discretion
    22. Known inability or unavailability of a patient to complete required study visits during study participation
    23. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patient's medical history, which, in the opinion of the investigator, may pose a threat to patient compliance
    24. Use of a platelet-derived growth factor within 28 days before screening
    25. Use of any investigational drug or therapy within 28 days before screening
    26. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints
    The primary efficacy endpoint is the following:
    • Incidence of complete wound closure at Week 12 based on
    investigator assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is the following:
    • Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period
    Other secondary efficacy endpoints are the following:
    • Incidence of complete wound closure at Week 24 (Month 6) based on investigator assessment
    • Mean percent wound reduction from baseline to Week 4 and Week 12 based on digital photographs
    • Incidence of wound recurrence for patients achieving complete closure based on investigator assessment
    • Clinical assessment of the target ulcer by the investigator
    • Incidence of amputation at or before Week 52
    • Change from baseline in 12 domain scores of the DFS at Week 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 - Week 52
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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
    vehicle controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    vehicle controlled
    E.8.2.4Number of treatment arms in the trial3
    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 EEA10
    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
    Canada
    Hungary
    India
    Poland
    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
    LSLV.
    The Principal Investigator and/or Sponsor has the right to terminate
    the study at any time in case of serious safety concerns or if special
    circumstance concerning the investigational product or the company
    occurs, making further treatment of patients impossible. In such an
    event, investigators will be informed of the reason for study
    termination.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 152
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 552
    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 Decision2018-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-05
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