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    Summary
    EudraCT Number:2021-000003-20
    Sponsor's Protocol Code Number:MEMPSOLAR0001
    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:2021-03-11
    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 number2021-000003-20
    A.3Full title of the trial
    AN INVESTIGATOR INITIATED, PHASE 4, OPEN-LABEL, SINGLE-ARM,
    SINGLE-CENTER STUDY INVESTIGATING THE RESIDUAL DISEASE MEMORY IN PSORIASIS SKIN DURING ENSTILAR® AND NARROW-BAND ULTRAVIOLET B THERAPY. THE MEMPSOLAR STUDY.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of residual disease MEMory in PSOriasis skin during EnstiLAR® and narrow-band ultraviolet B therapy. The MEMPSOLAR study.
    A.3.2Name or abbreviated title of the trial where available
    MEMPSOLAR STUDY
    A.4.1Sponsor's protocol code numberMEMPSOLAR0001
    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 SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLEO Pharma
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University
    B.5.2Functional name of contact pointDepartment of Dermatology, Thomas E
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Blvd. 99
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4551908840
    B.5.6E-mailthomas.emmanuel@clin.au.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 Yes
    D.2.1.1.1Trade name Enstilar
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameEnstilar
    D.3.2Product code Enstilar
    D.3.4Pharmaceutical form Cutaneous foam
    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 INNCALCIPOTRIOL
    D.3.9.1CAS number 112828-00-9
    D.3.9.4EV Substance CodeSUB06046MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBETAMETHASONE DIPROPIONATE
    D.3.9.3Other descriptive nameBETAMETHASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00783MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500000
    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 placeboCutaneous foam
    D.8.4Route of administration of the placeboTopical
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis vulgaris
    Psoriasis vulgaris
    E.1.1.1Medical condition in easily understood language
    Psoriasis vulgaris
    Psoriasis vulgaris
    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 LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    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
    1. Evaluate the efficacy of Enstilar® foam in combination with NB-UVB in changing the TRM-cells microenvironment in the skin.
    E.2.2Secondary objectives of the trial
    1. Evaluate the efficacy of Enstilar® foam in combination with NB-UVB in changing other immune cells using quantitative immunohistochemistry and gene expression analysis over the study duration.

    2. Evaluate the efficacy of Enstilar® foam in combination with NB-UVB on clinical and subjective disease activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be enrolled in the study if all of the following criteria are met at the screening (visit 1) and baseline (visit 2) visits:

    1. Women or men with chronic stable plaque psoriasis aged 18 years or older at the time of consent. Consent must be obtained prior to any study-related procedures. The participants must furthermore be willing to participate and must be of a condition capable of giving informed consent.

    Type of participant and disease characteristics:
    2. History of chronic stable plaque psoriasis.
    3. Candidate for topical treatment, as judged by the investigator.
    4. Candidate for NB-UVB treatment, as judged by the investigator.
    5. Two target lesions of ~3 cm at its longest axis located on the body (except for the scalp, face, or intertriginous areas), scoring at least 1 for each of redness, thickness, and scaliness on the TPSS.
    6. Women involved in any sexual intercourse that could lead to pregnancy must agree to use an effective contraceptive method from at least 4 weeks before baseline (visit 2). Effective contraceptive methods are: Systemic hormonal contraceptives (oral contraceptive, transdermal patches, vaginal rings, long-acting injectables, or implants), intrauterine devices, vasectomy, or barrier methods of contraception in conjunction with spermicide. This must be used until EOT. Hormonal contraceptives must be on a stable dose for at least 4 weeks before baseline (visit 2).
    a. Women of nonchildbearing potential are as follows:
    i. Women ≥60 years of age.
    ii. Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation)
    iii. Women >40 and <60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (FSH ≥40 mIU/mL) or cessation of menses for at least 24 months without FSH levels confirmed.
    7. A negative serum pregnancy test at screening and a negative urine pregnancy test at baseline (visit 2) must be presented by women of childbearing potential.
    E.4Principal exclusion criteria
    8. Female participant who is breastfeeding, pregnant, or who is planning pregnancy during the study period.
    9. History of concomitant skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments and the acquisition of biopsies.
    10. Other psoriasis subtype (erythrodermic, guttate, pustular, inverse, drug-induced).
    11. History or presence of signs or symptom of progressive or uncontrollable infectious, endocrine, neurological, renal, hepatic, cardiac, hepatic, vascular, pulmonary, gastrointestinal, hematological rheumatological, psychiatric or metabolic disturbance and/or abnormal blood test or vital signs other paraclinical information, including disorders of calcium metabolism, that, in the opinion of the investigator, may expose the patient to elevated or unnecessary risk or interfere with the interpretation of results.
    12. Known hypersensitivity to any ingredient in the IMP or to components of the container.
    13. Infectious skin lesions on treated areas (e.g., herpes, varicella, fungal, bacterial, and parasitic skin infections, skin manifestations in relation to tuberculosis).
    14. Treated skin must not be affected by perioral dermatitis, striae atrophicae, atrophic skin, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.
    15. History or presence of signs or symptoms of a light dermatosis (e.g., polymorphic light eruption, juvenile spring eruption, actinic folliculitis, actinic prurigo, solar urticaria, or chronic actinic/photosensitivity dermatitis.
    16. Participant has had, or is planning, a major surgery within 8 weeks prior to baseline during the study.
    17. Participant has a contraindication to skin biopsies.
    18. Are taking medication known to cause phototoxic reactions (e.g., nonsteroidal anti-inflammatory drugs, tetracyclines, or thiazides).
    19. Participant is currently receiving an investigational product or device or has received one within 4 weeks prior to baseline, that in the opinion of the investigator, might interfere with the results.
    20. Participant has used biologic medication 12 weeks prior to baseline visit (Day 0), or 5 half-lives (whichever is longer).
    21. Use of any systemic treatment for psoriasis (such as methotrexate, immunosuppressive drugs, corticosteroids, azathioprine, or cyclosporine) within 4 weeks prior to baseline.
    22. Use of any topical medication to treat psoriasis (including salicylic acid, retinoid, calcineurin inhibitors, corticosteroids, vitamin D analogue, or tar) within 2 weeks prior to baseline. Use of moisturizers and emollients are not exclusion criteria.
    23. Participant had psoralen and ultraviolet A (PUVA) treatment within 12 weeks prior to baseline.
    24. Participant had any UVB phototherapy (including tanning beds) or excimer laser within 12 weeks prior to baseline.
    25. Participant had excessive sun exposure within 2 weeks prior to baseline. This includes unwillingness to minimize natural and artificial sun exposure. Sunscreen products and protective apparel are recommended for circumstances when exposure cannot be avoided. Sunscreen must not be applied on the clinic visit days before the visit.
    26. Participant has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
    27. History of keloid formation or hypertrophic scarring in suture sites or scars.
    28. Known inability or unavailability of a participant to complete required study visits during study participation.
    29. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the participant’s medical history, which, in the opinion of the investigator, may obstruct compliance.
    30. Participant protected by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated).
    31. Mental or linguistic incapacity to sign the consent form.
    E.5 End points
    E.5.1Primary end point(s)
    • Change in number of TRM-cells in the epidermis and dermis between baseline, over the study duration.
    The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD69, CD103.
    • Change in type of TRM-cells in the epidermis and dermis between baseline, during the study duration assessed using analysis of microenvironment surround TRM-cells.
    The following markers in combination will be used to differentiate TRM-cells: CD3, CD4, CD8, CD69, CD103.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 8, Week 13, Week 18.
    E.5.2Secondary end point(s)
    • Change in CD11c+ Dendritic-cells over the study duration.
    • Change in CD163+ Macrophages over the study duration.
    • Change in Langerin+/CD207+ Langerhans-cells over the study duration.
    • Change in Myeloperoxidase+ Neutrophils over the study duration.
    • Change in FOXP3+ cells over the study duration.
    • Change in Proliferation as assessed using Ki67 over the study duration.
    • Change in CD49a+ cells over the study duration.
    • Change in epidermal thickness over the study duration.
    • Change in the whole skin transcriptome over the study duration.
    • Change over the study duration for standardized clinical parameters Psoriasis Area and Severity Index (PASI), the 5-point Investigator's Global Assessment (IGA), the Dermatology Life Quality Index (DLQI), the Target Plaque Severity Score (TPSS) and target plaque area (TPA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 8, Week 13, Week 18.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Split-body, vehicle-controlled
    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 trial1
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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.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)
    Participants will be treated at the sponsor and co-investigators discretion or referred to other physicians according to national treatment guidelines and clinical practice. This applies both for participants who dropout, decline to continue, or are excluded during the trial.
    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 Decision2021-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-19
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