Clinical Trials Register

Summary
EudraCT Number:	2019-000215-92
Sponsor's Protocol Code Number:	BYH1003
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-03-05
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

France - ANSM

A.2

EudraCT number

2019-000215-92

A.3

Full title of the trial

Prospective, randomized, double blinded, placebo controlled, multicentre study for the evaluation of efficacy and safety of a Tacrolimus-containing solution (TACRO-Skin) in subjects with mild to severe scalp psoriasis as well as recording of the systemic bioavailability of Tacrolimus

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical study with TACRO-Skin solution in subjects with mild to severe scalp psoriasis to investigate efficacy and safety of the solution

A.3.2

Name or abbreviated title of the trial where available

ScaTAC

A.4.1

Sponsor's protocol code number

BYH1003

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	Bay Pharma GmbH
B.1.3.4	Country	Germany
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	Bay Pharma GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bay Pharma GbmH
B.5.2	Functional name of contact point	Clinical trials information
B.5.3	Address:
B.5.3.1	Street Address	Christop Probst Weg 4
B.5.3.2	Town/ city	Hamburg
B.5.3.3	Post code	20251
B.5.3.4	Country	Germany
B.5.4	Telephone number	+494061135164
B.5.6	E-mail	info@baypharma.de

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	TACRO-Skin
D.3.2	Product code	TACRO-Skin
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tacrolimus
D.3.9.3	Other descriptive name	TACROLIMUS MONOHYDRATE
D.3.9.4	EV Substance Code	SUB23141
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
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.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	Cutaneous solution
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriasis

E.1.1.1

Medical condition in easily understood language

Psoriasis

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10037157
E.1.2	Term	Psoriasis of scalp
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to analyse the efficacy of a Tacrolimus-containing solution (TACRO-Skin) in subjects with mild to severe scalp psoriasis measured by scalp Investigator’s Global Assessment (s-IGA) after 8 weeks of treatment (TACRO-Skin vs. placebo).

E.2.2

Secondary objectives of the trial

• evaluate efficacy of a TACRO-Skin in subjects with mild to severe scalp psoriasis (TACRO Skin vs. placebo) through s-IGA, scalp Patient’s Global Assessment (s-PGA), scalp modified Psoriasis Area and Severity Index (S-mPASI), and Physician’s Global Assessment (PGA), Visual Analogue Scale (VAS scalp pruritus [itch])
• evaluate the effect on subject’s quality of life of TACRO-Skin treatment in subjects with mild to severe scalp psoriasis (TACRO-Skin vs. placebo)
• evaluate the systemic bioavailability of tacrolimus
• evaluate the safety of Tacrolimus

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PK analysis is planned in 15 subjects in the TACRO-Skin group. Blood samples shall be collected from 15 subjects per arm in a block-randomized manner. The PK laboratory will analyse only the samples of the 15 subjects treated with TACRO-Skin after unblinding; samples of the placebo group will not be analysed (see also section 9.5). Sampling will stop after 15 samples of TACRO-Skin group are available.

E.3

Principal inclusion criteria

1) Subjects must be able to understand the scope, risks and nature of the clinical study and decide
independently on their participation
2) Males and females aged 18 years or older at the time of informed consent
3) Caucasian
4) Women of childbearing age must use an established contraceptive method (e.g. contraceptive pill,
depot injection, spiral, abstinence, vasectomy of the partner), exceptions: 12 months of natural
amenorrhoea, postoperatively (6 weeks after bilateral ovariectomy with or without hysterectomy)
5) Women of childbearing age must demonstrate a negative pregnancy test (urine rapid test)
6) Mild to moderate psoriasis vulgaris (plaque psoriasis) with scalp involvement for at least 6 months
7) s-IGA of 2 (mild scalp involvement) to 4 (severe scalp involvement) and 20% or higher or 5x5 cm
or larger of scalp surface area (or 0.5% of Body Surface Area) affected
8) Discontinuation of systemic therapy with etanercept at least 4 weeks before start of study
treatment (Visit 2 - baseline)
9) Discontinuation of systemic therapy with adalimumab and infliximab at least 12 weeks before start
of study treatment (Visit 2 - baseline)
10) Discontinuation of systemic therapy with ustekinumab, all other biologics (incl. but not limited to
IL 17 antagonists and IL-23 antagonists), and tacrolimus at least 12 weeks before start of study
treatment (Visit 2 - baseline)
11) At least 4 weeks before start of study treatment (Visit 2 - baseline) discontinuation with other
systemic therapies that have an effect on psoriasis, such as corticosteroids, methotrexate,
retinoids, ciclosporin, fumaric acid esters, sulfasalzine, hydroxycarbamide, azathioprine,
apremilast and other immunosuppressant or immunomodulating drugs
12) Discontinuation of UV therapy at least 4 weeks before start of study treatment (Visit 2 - baseline)
13) Discontinuation of topical treatment such as steroids, Vitamin D, tar, salicylic acid, dimeticon, and
urea of scalp psoriasis at least 2 weeks before start of study treatment (Visit 2 - baseline)
14) Discontinuation of other physical and alternative therapy procedures (e.g. brine bath) at least
4 weeks before the start of study treatment (Visit 2 - baseline)

E.4

Principal exclusion criteria

Subjects meeting any of the following criteria will not be permitted to enter the study:
1) Participation in another clinical study at least 4 weeks before the inclusion date
2) Pregnancy, planned pregnancy, lactation period
3) Chronic inflammatory skin or systemic disease or a skin or systemic disease affecting the barrier
function of the skin, with the exception of psoriasis
4) Taking psoriasigen medicines (beta-blocker, angiotensin-converting-enzyme (ACE) inhibitors,
lithium, antimalarials). If beta-blockers and ACE inhibitors are taken for a longer period of time (at a stable dose at least 2 weeks before start of study treatment (Visit 2 - baseline)), the inclusion is
at the discretion of the Investigator
5) Intensive sun exposure (holiday, solarium) at least 4 weeks before start of study treatment (Visit 2
- baseline) and during the study
6) Non-drug treatments that could interfere with the conduct of the study
7) Use of vasoactive over-the-counter (OTC) products that interfere with the inflammation process of
the skin in the scalp area
8) Use of nutritional supplements that can affect inflammatory processes in the body
9) Use of calcineurin inhibitors during the study
10) Topical application of cosmetic or hair care products during the study (hair gel, hair spray, etc.)
11) Use of medical shampoos (e.g. tar shampoo)
12) Current or potential contraindications, incompatibility or hypersensitivity to any of the ingredients of
the IMP
13) Known drug abuse
14) Risk of haematological contagion (Human Immunodeficiency Virus (HIV), chronic or active
Hepatitis B or C)
15) Subjects in close affiliation with the study personnel (e.g. immediate family member or
subordinate), subjects who are a member of the clinical study personnel, or an employee of the
sponsor or a CRO involved in the study

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects achieving an improvement in s-IGA after 8 weeks of treatment (Visit 7) (TACRO-Skin vs. placebo) to scale 0 or 1

E.5.1.1

Timepoint(s) of evaluation of this end point

s-IGA at screening, week 0,1,2,4,6,8 and early termination

E.5.2

Secondary end point(s)

•Change from baseline in severity scores s-IGA, s-PGA, S-mPASI, PGA and VAS; scalp pruritus (itch)
•Change from baseline in quality of life via Scalpdex and Dermatology Life Quality Index (DLQI) from Visit 2 (baseline) to Visit 7 (end of treatment)

•Determination of the systemic bioavailability of Tacrolimus at Visits 2 and 7 in a subgroup of subjects
•Frequency of adverse events (AEs)

E.5.2.1

Timepoint(s) of evaluation of this end point

-s-IGA at screening, week 0,1,2,4,6,8 and early termination
-s-PGA, S-mPASI, PGA and VAS at week 0,1,2,4,6,8 and early termination
-QoL Scalpdex and DLQI at week 0,1,2,4,6,8 and early termination
-PK week 0 and week 8
-AE/SAE at all visits

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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

LVLS

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 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.1.2.1

Number of subjects for this age range:

101

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

128

F.4.2.2

In the whole clinical trial

128

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)

Normal standard of care

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

2019-04-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-08-03

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