Clinical Trials Register

Summary
EudraCT Number:	2010-023789-33
Sponsor's Protocol Code Number:	300904BS
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-12-03
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2010-023789-33

A.3

Full title of the trial

A phase IIa, multicenter, randomized, two-arm, observer-blind, vehicle and reference controlled proof of concept trial to investigate intra-individually (left/ right) the antipsoriatic efficacy and safety of once daily topical application of Valrubicin cream 1 % in comparison to vehicle and reference product in adult patients with stable plaque psoriasis

A.4.1

Sponsor's protocol code number

300904BS

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Valderm ApS
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Valderm ApS
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	bioskin GmbH
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Burchardstrasse 17
B.5.3.2	Town/ city	Hamburg
B.5.3.3	Post code	20095
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049406068970
B.5.5	Fax number	00494060689730

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Valrubicin cream 1%
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VALRUBICIN
D.3.9.1	CAS number	56124-62-0
D.3.9.2	Current sponsor code	valrubicin cream 1%
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Daivonex® 50 µg/g Creme
D.2.1.1.2	Name of the Marketing Authorisation holder	Leo Pharmaceutical Products Ltd. A/S
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Daivonex® 50 µg/g Creme
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIPOTRIOL
D.3.9.1	CAS number	112828009
D.3.9.3	Other descriptive name	Comparator
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cream
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Male or female subjects with stable plaque psoriasis

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13.1
E.1.2	Level	LLT
E.1.2	Classification code	10050576
E.1.2	Term	Psoriasis vulgaris
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the antipsoriatic efficacy of Valrubicin cream 1% in patients with plaque psoriasis in comparison to vehicle cream.

E.2.2

Secondary objectives of the trial

• To compare the efficacy of Valrubicin cream 1 % to Daivonex® 50 μg/g Creme
• To evaluate the tolerability and safety of Valrubicin cream 1 % in patients with plaque psoriasis in comparison to vehicle
• To investigate the efficacy of Valrubicin cream 1 % on skin thickness, skin morphology and biomarkers in plaque psoriasis in a subset of 12 patients (6 per treatment arm)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients are eligible for the trial if all of the following apply:
1. Male or female patient of at least 18 years;
2. Mild to moderate stable plaque psoriasis for at least 12 months as determined by patient history and typical lesions;
3. Patients have to have at least two comparable plaques suitable as target plaques
located on the trunk or extremities and which are not positioned directly at the elbows, knees or lower legs; target plaques should be located on left/right side and in the same body region although not necessarily symmetrical;
4. Skin type I - IV;
5. Willingness to discontinue the use of own treatment and cosmetic products (e.g. soaps, creams, moisturizers) in the treatment areas and neighboring skin throughout the course of the trial;
6. Female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
7. Written informed consent obtained.

E.4

Principal exclusion criteria

Patients will be excluded from participation if any of the following applies:
1. Patients requiring compulsory treatment;
2. Active skin disease apart from plaque psoriasis or tattoos in the target plaques;
3. Psoriasis erythrodermatica, psoriasis punctata and pustular psoriasis;
4. Known or suspected hypersensitivity to the active ingredient or any other ingredient of the IMPs and comparator;
5. Patients with severe liver and renal diseases;
6. Patients with known dysfunction of the calcium metabolism;
7. Evidence or history of drug- or alcohol abuse;
8. Pregnant women or women who intend to become pregnant during the trial or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the trial;
9. Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial in the four weeks before or during the trial;
10. Participation in any clinical trial within the last 60 days prior to the first administration of investigational drug in this trial;
11. Participation in a clinical trial for plaque psoriasis more than twice within 12 months prior to the first administration of investigational drug in this trial;
12. Participation in the previous trial (290408BS);
13. Known allergic reactions to components of the IMPs including comparator;
14. Local treatment with antipsoriatics (like vitamine D, dithranol, glucocorticosteroids) in the 4 weeks preceding and during the trial; and any topical antipsoriatic treatment on the plaques to be treated in this trial (including corticosteroids) in the 8 weeks preceding and during the trial;
15. Systemic treatment with antipsoriatics (e.g. retinoids or immunosuppressive therapy) or therapy with PUVA, selected ultraviolet photo-therapy in the three months preceding and during the trial;
16. Treatment with systemic or locally acting medications which might interact with the IMPs or impact the effect thereof (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. b-blocker, antimalarial and lithium drugs within two weeks before the beginning of the trial and during the trial;
17. Contraindications according to summary of product characteristics of the comparator;
18. If in the opinion of the investigator performing the initial examination the patient should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
19. Patient is institutionalized because of legal or regulatory order;
20. Employees of bioskin, third parties associated with the trial, or the site.

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy variable:
• Comparison of Valrubicin cream 1 % to vehicle cream with respect to change from
baseline in TSS (Total Severity Sign) score on day 29.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

observer-blind, intra-individual comparison of treatments

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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

The last day of the trial is trial day 29.
In a subset of patients (total 12 patients) biopsies will be taken on trial day 29. Seven to ten days after taking the biopsies the sutures will be removed and the biopsy sites will be controlled. For these patients the trial takes 7 to 10 days longer.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-12-03.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Further treatment is not intended. If a dermatiological treatment should become necessary - caused by participation in the trial - this will be provided free of charge by bioskin´s physicians (including appropriate medication).

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-02-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-12-28

P. End of Trial
P.	End of Trial Status	Completed

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