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    Summary
    EudraCT Number:2017-002193-40
    Sponsor's Protocol Code Number:DT-001-R-004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-21
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-002193-40
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Study to Assess the Safety and Efficacy of Three Doses of Clobetasol Propionate when Administered Intra-orally Twice Daily in Patients with Oral Lichen Planus (OLP) using Rivelin®-CLO patches
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in Oral Lichen Planus (OLP) patients to assess how safe and effective the Rivelin®-CLO patches are when applied in the mouth
    A.3.2Name or abbreviated title of the trial where available
    Intra-oral treatment of OLP with Rivelin®-CLO patches
    A.4.1Sponsor's protocol code numberDT-001-R-004
    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 SponsorAfyx Therapeutics 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 supportAfyx Therapeutics A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProinnovera GmbH
    B.5.2Functional name of contact pointHeidi Mueller
    B.5.3 Address:
    B.5.3.1Street AddressWienburgstrasse 207
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48159
    B.5.3.4CountryGermany
    B.5.4Telephone number+49151 26437928
    B.5.6E-mailheidi.mueller@proinnovera.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 nameRivelin®-CLO patch
    D.3.4Pharmaceutical form Oromucosal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLOBETASOL PROPIONATE
    D.3.9.1CAS number 25122-46-7
    D.3.9.4EV Substance CodeSUB01346MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 20
    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 placeboOromucosal patch
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral Lichen Planus (OLP). OLP is a common, chronic mucosal disease associated with a cell-mediated immunological dysfunction and characterized by exacerbations of inflammation, which can lead to ulcerations of the oral mucosa associated with pain and discomfort including oral burning sensations.
    E.1.1.1Medical condition in easily understood language
    OLP is a chronic condition affecting mucous membranes inside the mouth. OLP may appear as white, lacy patches; red, swollen tissues; or open sores causing burning, pain or other discomfort.
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10030983
    E.1.2Term Oral lichen planus
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To demonstrate the efficacy of three different doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks of treatment assessed by change in ulcer area.
    E.2.2Secondary objectives of the trial
    1. To demonstrate the efficacy of 3 doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks assessed by change in lesion area.
    2. To demonstrate the efficacy of 3 doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks assessed by change in 5-point erythema score.
    3. To demonstrate the efficacy of 3 doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks assessed by change in Clinical global impression of anatomical site score.
    4. To demonstrate the effect on patient reported daily symptoms (OLPSSM) when OLP lesions are treated by 3 doses of Rivelin®-CLO patches over 4 weeks.
    5. To investigate the comfort and sensation of wearing the Rivelin®-CLO and Rivelin® plain patches after first administration and after 2 weeks of treatment.
    6. To investigate the adhesion time of Rivelin®-CLO and Rivelin® plain patches applied to one OLP lesion over 4 weeks of treatment.
    7. To evaluate the safety of Rivelin®-CLO patches in treating OLP lesions over 4 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. OLP patients with at least one visible and measurable symptomatic ulcerative OLP lesion , assessable via OLP Clinician Reported Outcome Measure (OLPClinROM).
    2. Clinical diagnosis of symptomatic OLP supported by the Oral Lichen Planus Symptom Severity Measure (OLPSSM): The sum score of individual items #1 to #7 of the OLPSSM has to be 5 or more on at least 4 days (consecutive or not consecutive) during the last week prior to baseline/randomization visit.
    3. Diagnosis of LP histologically confirmed by result of either an existing clinically relevant biopsy or a new clinically representative biopsy taken at first screening visit (i.e., a biopsy report either indicative of OLP, LP or indicative of lichenoid inflammation will be sufficient).
    4. The written informed consent form has been signed and dated by the patient following receipt of verbal and written information about the study prior to carry out any study related activity.
    5. Patients aged ≥ 18 years.
    6. Patients practicing daily oral hygiene (by tooth brushing and/or mouth rinse) and willing to maintain at least their routine oral hygiene procedure during study participation.
    7. Willingness to keep already used permitted concomitant medication, food supplements (e.g. probiotics) or herbals, which might have in the discretion of the investigator a potential influence on OLP, on a stable basis from second screening (visit 1) to the end of study (visit 7).
    8. Only if a diagnostic biopsy needs to be taken at first screening visit: Complete healing of biopsy wound, including complete relief of pain associated with the biopsy site (defined as no / no further need to use any pain relief medication) at date of the second screening visit (visit 1).
    E.4Principal exclusion criteria
    1. Patients requiring more than 6 patches (corresponding to an area of approximately 3 cm2 per patch) to cover symptomatic ulcerative and erythematous OLP lesions at baseline visit.
    2. Ongoing active visible fungal, bacterial or viral infection of oral mucosa, including ongoing treatment of fungal or bacterial infection at second screening visit (visit 1) and/or at baseline visit.
    3. Patient with any not completely healed oral surgery (including recent diagnostic biopsies, if applicable) or oral laser therapeutic wound(s) at second screening visit (visit 1).
    4. Any of the following systemic treatments prior to baseline visit and throughout the study:
    - Protease inhibitors used for the treatment of HIV (e.g. atazanavir, idinavir, nelfinavir etc.): 1 week
    - Antimycotics: 4 weeks
    - Corticosteroids (i.v., intra-lesional, intra-articular): 4 weeks
    Note: intra-articular injections for the treatment of concomitant conditions (e.g. RA, activated arthrosis, acute gout, etc.) will be allowed if needed for non-OLP related disease flares during the study.

    The following systemic treatments are allowed, if on stable dose for a defined period of time prior to baseline (as stated below) and throughout the study.
    If not on stable dose as defined, these treatments are forbidden throughout the study and have to be washed out for the periods of time prior to baseline (as stated below):

    - Corticosteroids (oral, rectal, inhalative) washout/stable with maximum dose of 10 mg daily prednisolone or equivalent for 4 weeks
    - Antibiotics: washout/stable for 4 weeks
    - Retinoids: washout/stable for 12 weeks
    - Immunosuppressive drugs (e.g. azathioprine, cyclosporine, mycophenolate mofetil, hydroxychloroquine or biologics): washout/stable for 12 weeks
    5. Any of the following topical treatments used in the oral cavity prior to baseline visit:
    - Corticosteroids: 2 weeks
    - Antibiotics: 2 weeks
    - Cyclosporine: 2 weeks
    - Tacrolimus, pimecrolimus: 2 weeks
    - Antimycotics: 2 weeks
    - Retinoids: 4 weeks
    6. Phototherapy in oral cavity prior to baseline visit: UVB: 2 weeks, PUVA: 4 weeks.
    7. Current participation in another clinical study and/or having received treatment with any non-marketed / investigational medicinal product (drug substance or medical device) within 4 weeks prior to the first screening visit (visit 0).
    8. Known or suspected intolerance/hypersensitivity/resistance to clobetasol propionate or any component of the investigational medicinal product.
    9. Note: former exclusion criterion #9 was deleted as a consequence of amendment 04
    10. Any history of oral squamous cell carcinoma (even if resected), as well as history of other non-squamous cell carcinoma (e.g. sarcoma, salivary gland tumors) that have been managed with radiation or chemotherapy.
    11. History of cancer (except resected cutaneous basal cell carcinoma, except resected cutaneous squamous cell carcinoma and except resected in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years, or at least 2 years in a disease-free state for low-grade cancers. In case of clinical suspicion of malignancy in the oral cavity, a patient can only be included after an excluding biopsy.
    12. Any condition or disease or circumstances that in the Investigator’s opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results.
    13. Professional dental cleaning within 2 weeks prior to baseline and unwillingness to refrain from professional dental cleaning during study conduct.
    14. Patients known or suspected of not being able to comply with the study protocol (e.g. due to patient’s physical or mental inability, alcoholism, drug dependency, drug abuse, psychological disorder or other conditions).
    15. Close affiliation with the investigator (e.g. a close relative) or persons working at the study sites (if financially dependent on the investigator) or patient who is an employee of the Sponsor’s company.
    16. Pregnant, confirmed by a positive pregnancy test, or nursing (lactating) women, or women of childbearing potential (WOCP) planning to become pregnant or WOCP not using or willing to continue to use a defined highly effective method of contraception throughout the study.
    17. Only if a diagnostic biopsy needs to be taken at first screening visit (visit 0): Patients with any contraindication to biopsy procedures.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in ulcer area from baseline (visit 2) to average of visit 5 and visit 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the 4 weeks treatment period
    E.5.2Secondary end point(s)
    1. a) Change in lesion area from baseline to average of visit 5 and visit 6
    1. b) Change in 5-point erythema score from baseline to average of visit 5 and visit 6.
    1. c) Change in Clinical global impression of anatomical site score from baseline to average of visit 5 and visit 6.
    2. a) Change in OLPSSM total score (item #1 to #7) from baseline (run-in mean) to mean over weeks 3 and 4.
    2. b) Change in individual diary symptom scores (item #1 to #7 of the OLPSSM) from baseline (run-in mean) to mean over weeks 3 and 4.
    3. Change in worst symptoms at anatomical sites from baseline to average of visit 5 and visit 6.
    4. The proportion of positive outcomes (score 0 or 1) on each of the 11 questions in the Patch Sensation Questionnaire assessed at day 1 and after 2 weeks of treatment.
    5. The proportion of patients with successful (>=80% of days on treatment) patch applications defined as an adhesion time >=30 minutes during the 4 weeks treatment.
    6. a) Frequency and intensity of adverse events (AEs) reported during the study.
    6. b) Laboratory values and vital signs.
    6. c) Pseudomembranous candidiasis assessed by visual inspection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. a), b) and c): At the end of the 4 weeks treatment period.
    2. a) and b): At the end of the 4 weeks treatment period
    3. At the end of the 4 weeks treatment period.
    4. After 2 weeks of treatment.
    5. At the end of the 4 weeks treatment period.
    6. a): Ongoing until end of the study.
    6. b): At screening and at the end of study visit (visit 7)
    6. c): At each visit until end of 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 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) 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 EEA13
    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
    Denmark
    Germany
    Ireland
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 120
    F.4.2.2In the whole clinical trial 240
    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)
    After completion or early discontinuation of the present trial, subjects will be treated in accordance with normal clinical practice.
    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 Decision2018-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-20
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