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    Summary
    EudraCT Number:2016-001568-12
    Sponsor's Protocol Code Number:16-02/CalciBet-S
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-10
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-001568-12
    A.3Full title of the trial
    A multi-centre, randomised, double-blind, parallel-group phase III study to investigate the efficacy, safety, and tolerability of a generic calcipotriol-betamethasone ointment formulation compared to Daivobet® and vehicle in the treatment of adult patients with chronic stable plaque psoriasis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    not applicable
    A.3.2Name or abbreviated title of the trial where available
    Trial on Efficacy, Safety and Tolerability of Calcipotriol-Betamethasone
    A.4.1Sponsor's protocol code number16-02/CalciBet-S
    A.5.4Other Identifiers
    Name:Project number (CRO)Number:CDD16001
    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 SponsorDermapharm AG
    B.1.3.4CountryGermany
    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 supportDermapharm AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDermapharm AG
    B.5.2Functional name of contact pointClinical Research Department
    B.5.3 Address:
    B.5.3.1Street AddressLil-Dagover-Ring 7
    B.5.3.2Town/ cityGrünwald
    B.5.3.3Post code82031
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989641860
    B.5.5Fax number+498964186110
    B.5.6E-mailtanja.paal@dermapharm.de
    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 namecalcipotriol-betamethasone
    D.3.2Product code TEST
    D.3.4Pharmaceutical form Ointment
    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 monohydrate
    D.3.9.1CAS number 147657-22-5
    D.3.9.3Other descriptive nameCALCIPOTRIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26081
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Daivobet®
    D.2.1.1.2Name of the Marketing Authorisation holderLeo Pharma A/S, Denmark
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDaivobet®
    D.3.2Product code REFERENCE
    D.3.4Pharmaceutical form Ointment
    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 monohydrate
    D.3.9.1CAS number 147657-22-5
    D.3.9.3Other descriptive nameCALCIPOTRIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26081
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 placeboOintment
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic stable plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that topical treatment with the generic calcipotriol-betamethasone ointment formulation is therapeutically equivalent to the originator product Daivobet® ointment in the treatment of chronic stable plaque psoriasis as determined by the percentage reduction in modified Psoriasis Area and Severity Index (PASI).
    E.2.2Secondary objectives of the trial
    - to demonstrate that topical treatment with the generic calcipotriol-betamethasone ointment formulation is superior to vehicle (company’s ointment formulation) in the treatment of chronic stable plaque psoriasis as determined by the percentage reduction in modified Psoriasis Area and Severity
    Index (PASI).
    - to assess the efficacy of the generic calcipotriolbetamethasone ointment formulation in comparison to the originator product Daivobet® and vehicle (company’s ointment formulation) in the treatment of chronic stable plaque psoriasis in terms of improvement in:
    o Investigator's Psoriasis Global Assessment (IPGA) score;
    o Body Surface Area (BSA) affected by psoriasis;
    o Patient’s Psoriasis Global Assessment (PPGA) score.
    - to assess the safety and local tolerance of the generic calcipotriol-betamethasone ointment formulation in comparison to the originator product Daivobet® and vehicle (company’s ointment formulation).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Male or female patients ≥18 years of age.
    [2] Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk
    (but excluding face, scalp, genitals and intertriginous areas).
    [3] Psoriasis affecting less than 30% of the body surface area (BSA).
    [4] A modified PASI score of ≥5 to ≤15 at baseline (Visit 2).
    [5] Female patients of childbearing potential must have a negative pregnancy test prior to randomisation and must agree to use an appropriate method of contraception during the study.
    [6] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of
    subjective evaluations, attending scheduled visits, and compliance with protocol requirements as evidenced by providing signed written informed consent.
    E.4Principal exclusion criteria
    [1] History of hypersensitivity or intolerance to any active substance or any of the excipients of the study medication.
    [2] Current diagnosis of unstable forms of psoriasis in the area(s) to be treated with study medication, including guttate, erythrodermic, exfoliative, or
    pustular psoriasis.
    [3] Other inflammatory skin disease in the area(s) to be treated with study medication that may confound the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
    [4] Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the area(s) to be treated with study medication which could
    interfere with efficacy and safety evaluations.
    [5] History of psoriasis unresponsive to topical treatments.
    [6] Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), fungal and
    bacterial skin infections, parasitic infections, skin manifestation in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility
    of sin veins, ichthyosis, acne vulgaris, acne rosacea, dermal ulcers and wounds.
    [7] Other severe acute or chronic concomitant disease with severe impairment of the general condition.
    [8] Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible.
    [9] Current or past history or signs/symptoms suggestive of a clinically significant abnormality in calcium homeostasis with hypercalcaemia, vitamin D toxicity, severe renal impairment (CRCL <30 ml/min), or severe hepatic disorder (total bilirubin, AST, ALT, GGT, or AP >3 times the upper limit of normal).
    [10] Use of topical anti-psoriatic therapy (including topical retinoids, topical corticosteroids, vitamin D analogues, salicylic acid, anthralin, coal tar) within 2 weeks prior to baseline (Visit 2) and during the study.
    [11] Use of systemic corticosteroids (including inhaled and nasal steroids) within 4 weeks prior to baseline (Visit 2) and during the study.
    [12] Use of other systemic anti-psoriatic therapy, systemic antibiotics, or systemic anti-inflammatory agents within 1 month prior to baseline (Visit 2)
    and during the study.
    [13] Use of immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) or oral retinoids (e.g., acitretin) within 2 months prior to baseline (Visit 2) and
    during the study.
    [14] Chemotherapy or radiation therapy within 3 months prior to baseline (Visit 2) and during the study.
    [15] Use of systemic anti-psoriatic biologic therapy (e.g., alefacept, etanercept, infliximab, efalizumab, adalimumab) within 6 months prior to baseline (Visit 2) and during the study.
    [16] Psoralen + UVA (PUVA) therapy or UVB therapy within 1 month prior to baseline (Visit 2) and during the study.
    [17] Use of calcium supplements during the study.
    [18] More than 400 IU/day of vitamin D or vitamin D analogues during the study.
    [19] Initiation of or changes in non-anti-psoriatic concomitant medication(s) that could affect psoriasis (e.g., beta-blockers, lithium, ACE inhibitors) during the study.
    [20] Initiation of or changes to concomitant medication that could affect calcium metabolism (e.g., antacids, thiazide and/or loop diuretics, antiepileptics) during the study.
    [21] Use of tanning booth, sun lamps, or non-prescription UV light sources within 2 weeks prior to baseline (Visit 2) and during the study.
    [22] Use of topical skin products other than the assigned treatment (including moisturisers, new brands of make-up, creams, ointments, lotions, and
    powders) during the study.
    [23] Phototherapy within 2 weeks prior to baseline (Visit 2) and during the study.
    [24] Women with existing or intended pregnancy or during lactation.
    [25] Reasonable doubt concerning the co-operation of the patient.
    [26] Participation in another clinical study within the last 30 days prior to inclusion in this study.
    [27] Participation in this study at an earlier date.
    E.5 End points
    E.5.1Primary end point(s)
    Mean percent change from baseline in modified PASI score at the end of week 4. This endpoint undergoes descriptive and comparative statistical Evaluation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of the clinical part of the trial and database closure and blind review.
    E.5.2Secondary end point(s)
    - Mean percent change from baseline in modified PASI score at the end of week 1.
    - Proportion of patients with a reduction in modified PASI score of >75% between baseline and end of week 4 (responder).
    - Proportion of patients with a reduction in modified PASI score of >50% between baseline and end of week 4.
    - Mean percent change from baseline in IPGA at the end of week 1 and week 4.
    - Mean percent change from baseline in PPGA at the end of week 1 and week 4.
    - Proportion of patients with controlled disease (defined as "clear" or "almost clear") in IPGA at the end of week 4.
    - Proportion of patients with controlled disease (defined as "clear" or "almost clear") in PPGA at the end of week 4.
    - Mean percent change from baseline in BSA affected by psoriasis at the end of week 1 and week 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After completion of the clinical part of the trial and database closure. These endpoints undergo descriptive and comparative statistical Evaluation.
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned24
    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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 411
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 411
    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 state411
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 411
    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)
    There are no plans for further treatments.
    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 Decision2016-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-31
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