Clinical Trial Page

Summary
EudraCT Number:2006-001472-20
Sponsor's Protocol Code Number:LEO19123-C21
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:2006-07-14
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
A. Protocol Information
A.1Member State ConcernedDenmark - DHMA
A.2EudraCT number2006-001472-20
A.3Full title of the trial
LEO19123 Cream in the Treatment of Atopic Dermatitis

A Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitis
A.3.2Name or abbreviated title of the trial where available
LEO19123 Cream in the Treatment of Atopic Dermatitis
A.4.1Sponsor's protocol code numberLEO19123-C21
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorLEO Pharma 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 support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
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.3.2Product code LEO19123
D.3.4Pharmaceutical form Cream
D.3.4.1Specific paediatric formulation Information not present in EudraCT
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 Hydrate
D.3.9.1CAS number 147657-22-5
D.3.10 Strength
D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2Current sponsor codeLEO80122
D.3.10 Strength
D.3.10.1Concentration unit mg/g milligram(s)/gram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number0.2
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
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 Information not present in EudraCT
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 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.3.2Product code LEO19123
D.3.4Pharmaceutical form Cream
D.3.4.1Specific paediatric formulation Information not present in EudraCT
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 Hydrate
D.3.9.1CAS number 147657-22-5
D.3.10 Strength
D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2Current sponsor codeLEO80122
D.3.10 Strength
D.3.10.1Concentration unit mg/g milligram(s)/gram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number0.6
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
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 Information not present in EudraCT
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 placeboCutaneous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Atopic dermatitis
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10003639
E.1.2Term Atopic dermatitis
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.
E.2.2Secondary objectives of the trial
To compare the safety LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Signed informed consent has been obtained following verbal and written
information about the trial
2. Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka (see
Appendix III)
3. The score of each of the five clinical signs in Total Severity Score on the arms
should be ≥2 (moderate) at Visit 1
4. Treatment area amenable to topical treatment
5. Male gender
6. Age between 18-50 years
7. Attending a hospital outpatient clinic or the private practice of a dermatologist
E.4Principal exclusion criteria
1. Systemic treatment with immunosuppressive drugs (e.g. methotrexate,
cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to
randomisation. (Inhaled or in-tranasal steroids for asthma or rhinitis may be
used)
2. PUVA or UVB therapy within 4 weeks prior to randomisation
3. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or cortico-
steroids from WHO groups III or IV within 2 weeks prior to randomisation
4. Other topical therapy on the treatment area (except for the use of emollient on
the entire body and hydrocortisone cream 1% on head and neck lesions) within
1 week prior to randomisation
5. Use of any other kind of treatment for AD (drug , non-drug) during the study
except for the use of:
- investigational product on trunk and limbs lesions only during the treatment
phase
- hydrocortisone cream 1% on head and neck lesions
- emollient on the entire body
6. Use of anti-histamines during the study
7. Current diagnosis of exfoliative erythrodermia
8. Clinical infection (impetiginised atopic dermatitis) on the treatment area
9. Planned exposure to amount of sun or ultraviolet light during the study that may
affect atopic dermatitis
10. Known or suspected hypersensitivity to component(s) of the investigational
product
11. Known or suspected severe renal insufficiency or severe hepatic disorders
12. Patients with history/signs/symptoms suggestive of an abnormality of calcium
homeostasis associated with clinically significant hypercalcaemia
13. Patients with history of cancer including skin cancer
14. Patients with history of an immunocompromised disease (e.g. lymphoma, HIV,
Wiskott-Aldrich Syndrome)
15. Current participation in any other interventional clinical trial
16. Patients who have received treatment with any non-marketed drug substance
(i.e. an agent which has not yet been made available for clinical use following
registra-tion) within 4 weeks prior to randomisation
17. Previously randomised in this study
18. Patient known or, in the opinion of the investigator, is unlikely to comply with
the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
E.5 End points
E.5.1Primary end point(s)
The absolute change in Total Severity Score on the target area (the arms) from baseline to end of treatment.
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 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 Yes
E.7.1.2Bioequivalence study No
E.7.1.3Other Yes
E.7.1.3.1Other trial type description
Proof of Concept
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.8.3 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 concerned8
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA10
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 Information not present in EudraCT
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
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 months6
E.8.9.1In the Member State concerned days
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 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female No
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
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 state50
F.4.2 For a multinational trial
F.4.2.1In the EEA 75
F.4.2.2In the whole clinical trial 75
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 Decision2006-08-04
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-08-15
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2007-08-24

Sponsors and Collaborators

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