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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-000214-42
    Sponsor's Protocol Code Number:755-201-EB
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-04-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-000214-42
    A.3Full title of the trial
    A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INM-755 cream for patients with EB.
    A.4.1Sponsor's protocol code number755-201-EB
    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 SponsorInMed Pharmaceuticals Inc.
    B.1.3.4CountryCanada
    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 supportInMed Pharmaceuticals Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInMed Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Research Executive
    B.5.3 Address:
    B.5.3.1Street Address815 W Hastings St, #310
    B.5.3.2Town/ cityVancouver, British Colombia
    B.5.3.3Post codeV6C1B4
    B.5.3.4CountryCanada
    B.5.6E-mailclinical@inmedpharma.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 nameCannabinol (CBN)
    D.3.2Product code INM-755
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCANNABINOL
    D.3.9.1CAS number 521-35-7
    D.3.9.2Current sponsor codeINM-755
    D.3.9.4EV Substance CodeSUB06074MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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 placeboCream
    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
    Epidermolysis bullosa
    E.1.1.1Medical condition in easily understood language
    Epidermolysis bullosa
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10014989
    E.1.2Term Epidermolysis bullosa
    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 evaluate the safety of INM-755 cream in patients with EB.
    - To obtain preliminary evidence of efficacy of INM-755 cream on wound and non-wound
    affected skin areas in patients with EB.
    E.2.2Secondary objectives of the trial
    - To assess systemic exposure to cannabinol in a subset of patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals must meet all of the following criteria to be included in the study:
    1. Male or female patients aged ≥18 years with documented diagnosis of any of the following types of inherited EB:
    • EB simplex
    • Junctional EB
    • Dystrophic EB
    • Kindler EB
    Enrolment will be extended to patients ≥12 years old and <18 years old after positive opinion of a DMC after their review of safety and tolerability data from at least 4 adult patients who have completed at least 2 weeks of study treatment.
    2. Presence of at least 1 pair of index areas that are well matched in terms of type(s) of EB sign or symptom, severity, and size. To be eligible, the pair of index areas must be either non-wound areas with symptom of itch or wounds (that may or may not have associated pain or itch). Up to 2 pairs of index areas (1 pair of non-wound and 1 pair of wound index areas) can be selected and treated in each individual patient.
    For non-wound itch index areas, both areas should meet the following criteria:
    • Chronic itch, not associated with a wound, with a score ≥40 mm on a 100 mm VAS at the Screening Visit and with an average score ≥40 mm during the 7 days before the Baseline Visit, and present for the majority of time over the 6 weeks before to the Baseline Visit
    • Absence of wounds at the Screening and Baseline Visits that could qualify as an index wound (see below) in the index areas or that require wound dressing.
    • The area cannot also have a wound that has healed (re-epithelialised) within the past 3 weeks prior to Screening.
    • Extension of each index area to be treated should not exceed 20% of BSA and should not be less than 1% of BSA
    • A difference in the index areas to be treated not larger than 2-fold the area of the smallest index non-wound itch area at the Screening Visit
    • Additional signs or symptoms of EB other than itch from selected index areas do not need to be matched.
    If the pair of index areas are wounds, both wounds should meet all following characteristics:
    • Wounds with a surface area ≥5 cm2 and ≤50 cm2 inclusive at the Screening and Baseline Visits and aged ≥3 weeks at the Screening Visit
    • At Baseline Visit, each index wound should not present a surface reduction ≥30% from the Screening Visit
    • To be considered well-matched the index wounds must have:
    a. a difference in the surface area not larger than 2-fold the surface of the smallest index wound at the Screening Visit
    b. both must fit into the same duration window of either ≥3 weeks to 3 months before the Screening Visit or >3 months
    c. not located at anatomical sites with high likelihood of accidental trauma (e.g., knees, elbows)
    3. Female patients of childbearing potential or men whose sexual partners are women of childbearing potential (WOCBP) must be able and willing to use at least 1 method of contraception until the patient’s last study visit. The following are permitted contraceptive methods: intrauterine device, hormonal contraceptives (e.g., oral, patch, or injectable), male vasectomy (if vasectomy was medically confirmed). Abstinence from heterosexual intercourse is acceptable when this is the usual lifestyle of the patient. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy with or without hysterectomy).
    4. If the patient is a female of childbearing potential, patient should have a negative urine pregnancy test result at Screening and Baseline Visits.
    5. Must provide written consent and comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    Individuals meeting any of the following criteria at Screening or Baseline are ineligible to participate in this study:
    1. EB index areas have evidence of infection.
    2. Patient has evidence of a systemic infection or has used systemic antibiotics for EB-related infections within 7 days before the Baseline Visit.
    3. Administration of systemic corticosteroids within 30 days or of topical (except ophthalmic) corticosteroids on chosen index areas within 14 days before the Baseline Visit. Corticosteroids for inhalation or intranasal use are permitted provided they are taken at a stable dosing.
    4. Immunosuppressive therapy or cytotoxic chemotherapy within 60 days before the Baseline Visit.
    5. Use of any high potency opioid within 30 days prior to Baseline Visit.
    6. Use of cannabis, cannabis extracts, or any cannabinoid products for medical or recreational use by any route of administration within 2 weeks prior to the Baseline Visit. The patient can be using the cannabinoid-containing product at Screening but must commit to avoiding cannabinoid use in the prescribed timeframe.
    7. Patient has undergone stem cell transplant or gene therapy for the treatment of inherited EB.
    8. History of malignancy including basal cell carcinomas and squamous cell carcinomas.
    9. Arterial or venous disorder resulting in ulcerated wounds.
    10. Uncontrolled diabetes mellitus.
    11. Presence of chronic pruritus believed to be primarily attributable to concomitant pathologies or conditions other than EB (e.g., renal or cholestatic pathologies).
    12. Patient has received blood transfusion to treat anaemia within the past 3 months.
    13. Patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline Visit.
    14. Patient has an underlying condition which in the opinion of the investigator places the patient at unacceptable risk.
    15. Women who are pregnant, breastfeeding (lactating), or planning to become pregnant during the study.
    16. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
    17. Patient is an inmate of a psychiatric ward, prison, or state institution by virtue of an order issued either by the judicial or the administrative authorities.
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoints are:
    • Incidence of treated index areas with erythema, oedema, scaling, and stinging/burning identified from local tolerability assessment (LTA) by
    type of treatment and severity
    • Treatment-emergent local adverse event (AE) incidence, severity, and relationship with treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through out the study
    E.5.2Secondary end point(s)
    Other safety endpoints are:
    • Treatment-emergent systemic AE incidence, severity, and relationship with treatment
    • Change from Baseline (CFB) in vital signs
    • Incidence of treatment-emergent abnormal physical examination findings
    Efficacy Endpoints
    Preliminary evidence of efficacy will be evaluated based on the following endpoints as applicable:
    Non-wound Itch:
    • CFB in weekly average non-wound itch severity summarised from daily assessments by the patient using a 100 mm visual analogue scale (VAS)
    • Proportion of non-wound itch index areas achieving a 20 mm, 30 mm, or >30 mm reduction of itch VAS from Baseline to End of Treatment (EOT)
    • Patient's Impression of Change of Non-wound Itch (PIC-I) as assessed by the Dynamic Pruritus Scale (DPS) at each index area after 2 weeks and 4
    weeks of treatment
    Wound Surface Area:
    • Absolute and percent CFB in surface area of each index wound at the scheduled visits
    • Incidence of at least 25%, 50%, 75%, and 100% reduction in surface area from Baseline and incidence of first complete closure (defined as
    complete re-epithelialisation without drainage) of each index wound at the scheduled visits
    • Time to achieve 50% reduction from Baseline in surface area of each index wound
    • Time to achieve complete closure of each index wound
    Procedural Wound Pain:
    • CFB in weekly average index wound pain score associated with dressing change (procedural pain) summarised from assessments by the patient
    using a 100 mm VAS
    • Proportion of index wounds with associated procedural pain achieving a 20 mm, 30 mm, or >30 mm reduction of pain VAS from Baseline to EOT
    • Patient’s Impression of Change-Procedural Pain (PIC-PP) for each wound index area after 2 weeks and 4 weeks of treatment
    Background Wound Pain:
    • CFB in weekly average index wound pain score not associated with dressing change (background pain) summarised from daily assessments by
    the patient using a 100 mm VAS
    • Proportion of index wounds with background pain achieving a 20 mm, 30 mm, or >30 mm reduction of pain severity from Baseline to EOT
    • Patient’s Impression of Change-Background Pain (PIC-BP) for each wound index area after 2 weeks and 4 weeks of treatment
    Wound Itch:
    • CFB in weekly average wound itch summarised from daily assessments by the patient using a 100 mm VAS
    • Proportion of index wounds with associated itch achieving a 20 mm, 30 mm, or >30 mm reduction of itch severity from Baseline to EOT
    • Patient’s Impression of Change-Wound Itch (PIC-WI) for each index area after 2 weeks and 4 weeks of treatment
    Pharmacokinetic Endpoint
    The pharmacokinetic (PK) endpoint of this study is systemic exposure to cannabinol (CBN) measured at completion of treatment (in a subset of patients).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through out the study
    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 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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Intra individual comparison
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Austria
    France
    Germany
    Greece
    Israel
    Italy
    Serbia
    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
    Last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 8
    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: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents 12-17 years old
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 20
    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 revert to their normal standard of care.
    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 Decision2021-08-13
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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