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    Summary
    EudraCT Number:2018-000685-12
    Sponsor's Protocol Code Number:MC2-01-C6
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-22
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-000685-12
    A.3Full title of the trial
    A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and their Metabolites after application of MC2-01 Cream in Adolescent Subjects (age 12 to 16 years, 11 months) with Extensive Psoriasis Vulgaris
    Multicentrické, otevřené klinické hodnocení k zhodnocení bezpečnosti a farmakokinetického profilu aktivních látek a jejich metabolitů po aplikaci maximální použitelné dávky krému MC2-01 u jedné skupiny dospívajících subjektů (ve věku od 12 do 16 let a 11 měsíců) s rozsáhlou lupénkou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of a new formulation (cream) to evaluate the safety in adolescent subjects with extensive psoriasis vulgaris.
    A.4.1Sponsor's protocol code numberMC2-01-C6
    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 SponsorMC2 Therapeutics Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportMC2 Therapeutics Ltd.
    B.4.2CountryUnited Kingdom
    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 pointAnnika Michaelis
    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+49251270778282
    B.5.5Fax number+492512707786282
    B.5.6E-mailannika.michaelis@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 nameMC2-01 cream
    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 INNCalcipotriol
    D.3.9.1CAS number 112965-21-6
    D.3.9.3Other descriptive nameCALCIPOTRIOL, ANHYDROUS
    D.3.9.4EV Substance CodeSUB22029
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetamethasone dipropionate
    D.3.9.1CAS number 5593-20-4
    D.3.9.3Other descriptive nameBETAMETHASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00783MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.64
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Extensive Psoriasis Vulgaris
    E.1.1.1Medical condition in easily understood language
    Psoriasis is a long-lasting autoimmune disease characterized by patches of abnormal skin
    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
    To evaluate the effect of MC2-01 cream on the HPA axis and calcium metabolism following once daily topical application under maximum-use conditions in subjects with extensive psoriasis vulgaris.
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetic profile of the active ingredients and their main metabolites following once daily topical application of MC2-01 cream under maximum-use conditions in adolescent subjects (age 12 to 16 years, 11 months) with extensive psoriasis vulgaris.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The parent(s), or legal guardian(s)have provided written informed consent.

    The subject has provided written assent to the trial.

    Healthy males or non-pregnant females, who are between 12 to 16 years, 11-month-old.

    Clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months, with or without scalp

    Treatment area between 10% and 30% of the BSA on the body and scalp

    At least moderate severity on the treatment area

    Normal HPA axis function

    Serum albumin-corrected calcium below the upper reference limit at SV2

    Negative urine pregnancy test for WOCP and use of a highly effective method of contraception
    E.4Principal exclusion criteria
    Unstable forms of psoriasis

    Other inflammatory skin disease in the treatment area

    Presence of pigmentation or extensive scarring in the treatment area

    Use of phototherapy within 4 weeks prior to inclusion

    Current or past history of disorders of calcium metabolism

    Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin

    Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors and inducers

    Use of topical treatments for Psoriasis 2 weeks prior to inclusion

    Systemic treatment with biological therapies for Psoriasis

    Use of systemic medication that suppresses the immune system

    Use of life vaccines

    Known allergic asthma or serious allergies

    Skin infections

    Known human immunodeficiency virus (HIV) infection

    Known or suspected of hypersensitivity to any component of the test product or reference
    product

    Any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject

    Females who are pregnant, breast feeding, or planning a pregnancy

    Participation in another clinical trial or received an IP or non-marketed drug substance
    within 30 days

    Previously enrolled in this trial

    Subject is unlikely to comply with the clinical trial protocol in the opinion of the investigator

    E.5 End points
    E.5.1Primary end point(s)
    HPA axis:
    The assessment of HPA axis suppression and of changes in calcium metabolism are the primary endpoints in this trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4 and Week 8 of treatment
    E.5.2Secondary end point(s)
    Plasma PK parameters

    Adverse Events



    E.5.2.1Timepoint(s) of evaluation of this end point
    Plasma PK: week 4 of treatment

    Adverse Events: after treatment has finished
    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 No
    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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 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 concerned4
    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 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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    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: 30
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Once subjects have completed the trial they will be treated as per standard medical practice for this patient population
    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 Decision2018-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-11
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