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    Summary
    EudraCT Number:2019-001483-30
    Sponsor's Protocol Code Number:BBH-GMCSF-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001483-30
    A.3Full title of the trial
    Effect of topical rhGM-CSF on the healing of venous leg ulcers: a randomized, placebo-controlled, double-blind, clinical phase II study
    Effekten af lokal behandling med rhGM-CSF på heling af venøse bensår: Et randomiseret, placebo-kontrolleret, dobbeltblindet, fase II studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of local treatment with rhGM-CSF on the healing of venous leg ulcers
    Effekten af lokal behandling med rhGM-CSF på heling af venøse bensår
    A.3.2Name or abbreviated title of the trial where available
    Repogel-01
    Repogel-01
    A.4.1Sponsor's protocol code numberBBH-GMCSF-01
    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 SponsorReponex Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    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 supportReponex Pharmaceuticals A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Dermatology and Copenhagen Wound Healing Center
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Hospital, Bispebjerg Bakke 23
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4553609159
    B.5.6E-mailewa.anna.burian@regionh.dk
    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 nameRepogel
    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 INNMOLGRAMOSTIM
    D.3.9.1CAS number 99283-10-0
    D.3.9.4EV Substance CodeSUB09040MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Venous leg ulcers
    Venøse bensår
    E.1.1.1Medical condition in easily understood language
    Leg ulcers
    Skinnebenssår
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10047260
    E.1.2Term Venous ulceration
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of rhGM-CSF on ulcer size reduction, when applied directly in the wound bed of difficult-to-heal venous leg ulcers, given on top of standard care. This will be evaluated by measuring the ulcer area change after 4 weeks of treatment compared to placebo.

    At undersøge om topikal rhGM-CSF kan mindske sårstørrelsen da det smøres direkte i sårbunden af vanskeligt-helende venøse bensår, da behandlingen adderes til almindelig sårbehandling. Dette vil blive evalueret gennem måling af ændring af sårstørrelsen efter 4 ugers behandling, sammenlignet med placebo.
    E.2.2Secondary objectives of the trial
    To study the effect of topical rhGM-CSF on complete wound healing, the time to complete healing and a clinical evaluation of the wound healing process. The safety and the mechanisms of action of the intervention will be studied as well. Finally, the effect of topical rhGM-CSF on inflammation will be studied in terms of clinical signs and relevant biomarkers in the wound microenvironment, as well as studies on the microbiome.
    At undersøge effekten af topikal rhGM-CSF på total sårheling, tiden til total sårheling og en klinisk evaluering af sårhelingsforløbet. Sikkerheden og virkningsmekanismen af interventionen kommer også at undersøges. Desuden undersøges effekten af topikal rhGM-CSF på inflammationen gennem kliniske tegn og relevant biomarkører i det lokale sårmikromiljø, såvel som studier af mikrobiomet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged ≥18 years
    2. Patients with at least one difficult-to-heal venous leg ulcer on standard care (diagnosed by clinical evaluation) localized between the knee and ankle, including the perimalleolar area.
    3. Venous insufficiency confirmed by a venous Doppler/duplex ultrasound scan. A previous scan before randomization can be used. If there is no previous adequate scanning, a new scanning has to be performed before randomization.
    4. Ulcer size 2-75 cm2 at randomization day (D0), the upper limit being defined as the largest ulcer in size that fits the area selection criteria
    5. Ulcer duration ≥2 months and ≤3 years
    6. Negative p-HCG for women of childbearing potential
    7. Patient able to understand Danish
    8. Patient able to comply with the protocol
    9. Patient fully informed about the study and having given written informed consent
    1. Mænd og kvinder, 18 år eller ældre
    2. Patienter med mindst ét sværbehandlet venøst bensår (på almindelig sårbehandling), lokaliseret mellem knæet og anklen (inklusive området rundt om knysten/malleolen)
    3. Venøs insufficiens, konfirmeret med en venescanning. En tidligere scanning kan bruges.
    4. Sårstørrelse på 2-75 cm2 på screeningsdagen (D0), defineret som det største sår der opfylder sårstørrelseskriteriet
    5. Sårvarighed ≥2 måneder og ≤3 år
    6. Negativ HCG (graviditets prøve) i blodet for fødedygtige kvinder
    7. Kunne forstå dansk
    8. Kunne følge forsøgsprotokollen
    9. Blevet fuldt informeret det kliniske forsøg og givet frivilligt informeret samtykke og har underskrevet samtykkeerklæringen
    E.4Principal exclusion criteria
    1. Characteristics of the index ulcer:
    a. Exposed bone, tendon, ligament, cartilage, joint or muscle
    b. Cellulitis or clinical ulcer infection at the screening day D-4, or the day of randomization, D0.
    c. Ulcers adjacent to the index ulcer that could interfere with the index ulcer, as judged by investigator
    2. Patients that are unsuitable for the compression therapy used in the study
    3. Known allergy towards GM-CSF, excipients or any other substances or remedies used in the trial.
    4. Vascularization: Ankle-brachial index ≤0.7
    5. Active or history of following diseases:
    a. Cancer (past history of well-treated cancer is however accepted after a control period of more than two years).
    b. Following autoimmune diseases: rheumatoid arthritis, autoimmune thrombocytopenia, thyroiditis, psoriasis, nephritis or multiple sclerosis.
    c. Lower extremity deep venous thrombosis within the last 3 months
    6. Any of following active diseases:
    a. Serious heart disease, including unstable angina pectoris, a major cardiac event such as myocardial infarction, congestive heart failure NYHA class III-IV within 3 months before the study
    b. Neutrophilic dermatoses (e.g. pyoderma gangrenosum and Sweet’s syndrome)
    c. Severe renal-, hepatic or pulmonary insufficiency or severely dysregulated diabetes, as judged by investigator
    d. Myeloproliferative diseases and hematologic diseases (e.g. myelodysplastic syndrome and leukemia). Anemia due to chronic infection or due to deficiency of iron, B12 or folic acid is accepted if Hb >5 mmol/L).
    e. Significant dementia
    7. Biochemistry with clinically significant abnormalities that could preclude study participation as judged by the investigator, such as:
    a. eGFR <20 mL/min/1.73 m2
    b. Hb <5 mmol/L
    c. ALAT >1.5 x upper limit of normal value
    d. Albumin < 20 g/l
    8. Prohibited therapy:
    a. Systemic immunosuppressive treatment, immunomodulators, cytotoxic chemotherapy (exception: usage of corticosteroids) on D-4 or D0.
    b. Corticosteroids with a daily dose equivalent to >10 mg of prednisolone per day on D-4 or D0.
    c. Topical corticosteroids in the index ulcer bed or within 1 cm of the ulcer edge on D-4 or D0.
    d. Biologics within 3 months of D-4 (anti-VEGF treatment in the eye in e.g. diabetics is however allowed).
    9. Weight <50 kg or BMI >50
    10. Participation in another clinical trial
    11. Planned surgery or hospitalization during trial
    12. Pregnant or lactating woman. Positive pregnancy test during run-in.
    13. Failure to agree to using an adequate method of contraception (having a failure rate of < 1% per year) throughout the study period for heterosexually active males and females of childbearing potential, or disagreement to remain abstinent (refrain from heterosexual intercourse). A woman is considered to be of childbearing potential if she is post-menarche and:
    a. Has not reached a postmenopausal state (≥60 years of age and amenorrhea for at least ≥12 months with no identified cause other than menopause, and has not undergone surgical sterilization: removal of ovaries and/or uterus) - OR
    b. No menses for over a year and confirmed by follicle-stimulating hormone (FSH) levels elevated into the postmenopausal range
    Examples of contraceptive methods with a failure rate of <1% per year includes bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives, hormone-releasing intrauterine devices and copper intrauterine devices. Male participants must be abstinent or use a condom during the trial period.
    14. Blood or sperm donation during trial
    15. Patient has previously been randomized in this study (rescreening is accepted otherwise)
    16. Judgment by the investigator that the patient is not suited for study participation
    1. Vedrørende det udvalgte venøse bensår (”indexsåret”):
    a. Blottet knogle, sene, ligament, brusk, led eller muskel
    b. Cellulit (hudinfektion) eller tegn på sårinfektion på screeningsdagen D-4, eller randomiseringsdagen, D0.
    c. Sår nærliggende indexsåret der kan forstyrre indexsåret, bedømt af forsøgslægen
    2. Patienter som ikke kan bruge den udvalgte kompressionsbehandlingen i studiet
    3. Allergi imod GM-CSF, excipienser eller andre stoffer/materialer som bruges i forsøget
    4. Blodtilførsel i benet: Ankel-brachial index ≤ 0,7
    5. Aktiv eller tidligere sygehistorie med følgende sygdomme:
    a. Kræft (tidligere sygehistorie af velbehandlet kræft accepters dog efter en kontrolperiode på mere end to år)
    b. Følgende autoimmune sygdomme: gigt, autoimmun trombocytopeni, thyroidit, psoriasis, nefritis eller multipel sklerose
    c. Blodprop i de dybe vener indenfor 3 måneder
    6. Nogle af følgende aktive sygdomme:
    a. Svær hjertesygdom, inkluderende ustabil angina pectoris, eller store hjertehændelser som blodprop I hjertet, hjertesvigt (NYHA klasse III-IV) indenfor de sidste 3 måneder
    b. Neutrofile dermatoser (fx pyoderma gangrenosum eller Sweet’s syndrome)
    c. Svær nyre-, lever- eller lungesygdom, eller svært reguleret diabetes, bedømt af forsøgslægen
    d. Myeloproliferative sygdomme (knoglemarsssygdomme) og hæmatologiske sygdomme (blodsygdomme), fx myelodysplastisk syndrom og leukemi. Anæmi (blodmangel) grundet kronisk infektion eller grundet mangler på jern, B12 eller folisyre accepters dog om blodprocenten Hb >5 mmol/L)
    e. Signifikant demens
    7. Blodprøver med klinisk betydende abnormaliteter bedømt af forsøgslæge, så som
    a. eGFR <20 (nyrefunktion)
    b. Hb <5 mmol/L (blodprocent)
    c. ALAT >x1,5 normal value (levertal)
    d. Albumin <20 g/l (protein)
    8. Forbudt behandling:
    a. Systemisk immunsupression, immunomodulatorer, kemoterapi (undtaget brug af kortikosteroider) D-4 eller D0.
    b. Behandling med kortikosteroider med en daglig dosis tilsvarende >10 mg prednisolon per dag, D-4 eller D0.
    c. Lokal behandling med kortikosteroider i indexsåret eller indenfor 1 cm fra sårkanten D-4 eller D0.
    d. Patienter i biologisk behandling de sidste 3 måneder fra D-4 (anti-VEGF behandling i øjet accepteres dog).
    9. Vægt <50 kg eller BMI >50
    10. Deltagelse i et andet klinisk forsøg
    11. Planlagt kirurgi eller hospitalisering under forsøget
    12. Gravide eller ammende kvinder. Positiv graviditetstest under run-in perioden.
    13. Uenighed om at bruge adækvat prævention (med en fejlrate < 1% per år) gennem studiet for heteroseksuelt-aktive mænd og kvinder i fødedygtig alder, eller uenighed om at være abstinent (afstå fra heteroseksuelt samleje). En kvinde anses at være i en fødedygtig alder efter den første menstruation og:
    a. Har ikke nået klimakteriet (≥60 år og ingen menstruation i mindst ≥ 12 måneder med ingen anden forklaring anden end klimakteriet, og har ikke gennemgået kirurgisk sterilisation: fjernelse af æggestokke og/eller livmoder) ELLER
    b. Ingen menstruation over ét år og forhøjet follikel-stimulerende hormon der tilsvarer post-klimakteriealderen.
    Eksempel på prævention med en fejlrate < 1% inkluderer aflukning af begge æggeleder, mandlig sterilisation, korrekt brug af hormonel prævention fx p-piller og minipiller, hormonafgivende spiraler og kobber-spiraler. Mandlige deltagere skal under hele forsøgsperioden bruge kondom ved samleje, eller være kønsligt afholdende.
    14. Blod- eller spermadonation under forsøget
    15. Tidligere randomisering (tildelning af forsøgsmedicin/blindpræparat) i dette studie
    16. Eventuelle andre forhold, som forsøgslederen vurderer kan gøre opfølgning eller forsøgsdeltagelse uhensigtsmæssig
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients reaching a 40% ulcer area reduction, or more, 4 weeks after initiation of the study drug treatment/placebo
    Andel patienter der opnår en 40% reduktion af sårarealen, eller mere, 4 uger efter initiering af forsøgsmedicinen/placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after randomization
    4 uger efter randomisering
    E.5.2Secondary end point(s)
    1. Absolute and percentage change of the ulcer area
    2. Complete ulcer healing
    3. Time to complete ulcer healing
    4. Clinical improvement of the wound healing process
    5. Degree of inflammation, granulation tissue, necrosis/slough, exudation and infection
    6. Changes in the levels of cytokines and growth factors in the wound fluid
    7. Changes in the microbiome
    8. Assessment of the safety profile
    1. Absolut og procentuel ændring af sårstørrelsen
    2. Total sårlukning
    3. Tid til total sårheling
    4. Klinisk forbedring af sårhelingen
    5. Vurdering af inflammation, sårbund, sårvæskemængde og infektion
    6. Ændringer i sårvæskeniveauer af vækstfaktorer og cytokiner (små signalmolekyler)
    7. Ændringer i mængden bakterier
    8. Sikkerhed: Forekomst af enhver bivirkning af forsøgsmedicinen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see protocol.
    Var venlig, se protokol.
    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 Yes
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state48
    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)
    Standard wound care is continued.
    Almindelig sårbehandling fortsætter.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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