Clinical Trials Register

Summary
EudraCT Number:	2020-003929-27
Sponsor's Protocol Code Number:	LP0053-2187
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-10-08
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

Denmark - DHMA

A.2

EudraCT number

2020-003929-27

A.3

Full title of the trial

Assessing target lesion score via daily photograph capture in subjects with psoriasis vulgaris on the body treated once daily with topical LEO 90100 (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g [as dipropionate]) or vehicle.

A.3.1

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

The effect of Enstilar® on psoriasis captured via daily photos taken at home.

A.3.2

Name or abbreviated title of the trial where available

PSO-IDEAL (PSOriasis-trial with daily Image capture in a Decentralized setting with EnstiLar)

A.4.1

Sponsor's protocol code number

LP0053-2187

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	LEO Pharma A/S (also referred to as LEO Pharma)
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	LEO Pharma A/S
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	LEO Pharma A/S
B.5.2	Functional name of contact point	Global Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Industriparken 55
B.5.3.2	Town/ city	Ballerup
B.5.3.3	Post code	DK-2750
B.5.3.4	Country	Denmark
B.5.6	E-mail	raleodk@leo-pharma.com

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	Yes
D.2.1.1.1	Trade name	Enstilar (R)
D.2.1.1.2	Name of the Marketing Authorisation holder	LEO Pharma A/S
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Enstilar
D.3.2	Product code	LEO 90100
D.3.4	Pharmaceutical form	Cutaneous foam
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	Calcipotriol hydrate
D.3.9.1	CAS number	147657-22-5
D.3.9.3	Other descriptive name	CALCIPOTRIOL MONOHYDRATE
D.3.9.4	EV Substance Code	SUB26081
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.05
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Betamethasone dipropionate
D.3.9.1	CAS number	5593-20-4
D.3.9.3	Other descriptive name	BETAMETHASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00783MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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 foam
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 vulgaris

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	10050576
E.1.2	Term	Psoriasis vulgaris
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 of this trial is to evaluate the change in target lesion score via daily photograph capture in people with psoriasis vulgaris on the body, in a 4 weeks randomised controlled trial in a decentralised/hybrid setting in subjects treated with LEO 90100 or vehicle.

E.2.2

Secondary objectives of the trial

The secondary objectives are

To assess clinical effect by evaluating itch, pain and psoriasis-related sleep loss NRS, (r-)PGA, (r-)m-PASI, DLQI and PSI in the DCT and hybrid trial setting, respectively.

And

Collection of adverse events in a decentralised and hybrid clinical trial in subjects with psoriasis vulgaris treated with LEO 90100 or vehicle.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must understand and comply with the requirements of the trial including handling of digital devices and must fulfil all of the following criteria to be eligible for the trial:

1. Signed and dated informed consent has been obtained prior to any protocol related procedures.

2. Having access to a suitable smartphone to complete the digital steps of the study (Android operating system: Android 9.0 or higher; iOS operating system 12.0 or higher).

3. A self-reported diagnosis of psoriasis vulgaris for at least 6 months on the trunk and/or limbs (excluding psoriasis on genitals and skin folds), involving 2-10% of the self-reported BSA. The clinical diagnosis of psoriasis vulgaris will be confirmed based on evaluation of the photographs taken.

4. Adult subjects at the age of 18 years or more.

5. A self-reported target lesion at screening of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), and scoring at least 1 (‘mild’) for each of redness, thickness and scaliness, and at least 4 in total of the remote target lesion score.

6. A r-PGA score of ≥2 at screening and at randomisation and a r-mPASI score of ≥2 at screening and at randomisation.

7. Female subjects of childbearing potential* must use a highly effective** form of birth control from screening throughout the trial.

*A female is defined as not of childbearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (hysterectomy or bilateral ovariectomy).
**A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. If the subjects are not already on a highly effective method of birth control the subjects cannot be included in the trial. The subjects must be able to document a highly effective method of birth control for at least 30 days prior to randomisation and continue until the last application of IMP. The subjects must confirm a negative pregnancy test before being randomised. Method of birth control must be documented in the concomitant medication.

E.4

Principal exclusion criteria

Subjects are not eligible for the trial if they fulfil any of the following criteria:

1. Treatment with Enstilar® at the time of screening.

2. Any previous and current systemic treatment with biological therapies with a possible effect on psoriasis will not be allowed in this trial.

3. Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, and ciclosporin) within 4 weeks prior randomisation.

4. Treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (if 5 half-lives is longer than 4 weeks, then we do not allow the subject in the trial) prior to randomisation.

5. Topical anti-psoriatic treatment on the trunk and/or limbs (except for emollients) within 2 weeks prior to randomisation.

6. Psoriasis on the face, scalp, and skin folds.

7. Pre-existing overt atrophy or telangiectasia in treatment areas.

8. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

9. Any cutaneous or systemic disease considered by the investigator to be significant, uncontrolled or immunocompromising and/or placing the subject at undue risk of intercurrent diseases.

10. Other inflammatory skin disorders (e.g. seborrheic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis.

11. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

12. Known or suspected hypersensitivity to component(s) of investigational products.

13. Current participation in any other interventional clinical trial.

14. Previously screened in this trial.

15. In the opinion of the investigator, the subject is unlikely to comply with the clinical trial protocol (e.g. due to lack of skills for using smartphone, alcoholism, drug addiction, psychotic state).

16. Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding.

17. Subjects in close affiliation with the trial personnel (e.g. immediate family member or subordinate), subjects being a member of the clinical trial personnel, or being an employee of the sponsor or a CRO involved in the trial.

18. Subjects who are institutionalised by court order or by local authority.

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint:
Change in total remote target lesion score via daily photograph capture from baseline to Day 28

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline to Day 28 on a daily basis.

E.5.2

Secondary end point(s)

Secondary endpoint(s):

Time to 50 % reduction in psoriasis itch NRS
Time to 50% reduction in psoriasis pain NRS
Time to 50% reduction in psoriasis-related sleep loss NRS

Achieving r-PGA 0/1 (with a at least 2 step improvement from Day 1) at Day 7
Achieving r-PGA 0/1 (with a at least 2 step improvement from Day 1) at Day 28
Achieving r-mPASI75 at Day 7
Achieving r-mPASI75 at Day 28

Achieving PGA vs r-PGA 0/1 (with a at least 2 step improvement from Day 1) at Day 7
Achieving PGA vs r-PGA 0/1 (with a at least 2 step improvement from Day 1) at Day 7
Achieving PGA vs r-PGA 0/1 (with a at least 2 step improvement from Day 1) at Day 28
Achieving r-mPASI75 vs mPASI75 at Day 7
Achieving r-mPASI75 vs mPASI75 at Day 28

Change in DLQI from treatment start (Day 1) to Day 7
Change in DLQI from treatment start (Day 1) to Day 28
Change in PSI from treatment start (Day 1) to Day 7
Change in PSI from (Day 1) Day 28
Change in r-mPASI from treatment start (Day 1) to Day 7
Change in r-mPASI from treatment start (Day 1) to Day 28
Change in psoriasis itch NRS from baseline1 to Day 28
Change in psoriasis pain NRS from baseline1 to Day 28
Change in psoriasis-related sleep loss NRS (weekly average) from baseline1 to Day 28

Change in remote vs in-clinic total target lesion score from randomisation to Day 28
Change in r-mPASI vs mPASI from randomisation to Day 28

Absolute difference between mPASI and r-mPASI being less than one or less than 25%
Absolute difference between PGA and r-PGA zero or less than one
Absolute difference between total target lesion score and in-clinic total target lesion score less than one

Number of treatment emergent AEs from treatment start (Day 1) to Day 28

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.2 where the timepoints are described beside each end-point.

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

E.8.1.7.1

Other trial design description

Decentralised and Hybrid clinical trial

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

Yes

E.8.4

The trial involves multiple sites in the 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

The end of trial overall is defined as the last in-clinic or video/phone appointment of the last subject in the trial globally.
Final collection of data for the primary endpoint occurs at Day 28.

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

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:

100

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

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

105

F.4.2.2

In the whole clinical trial

105

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)

After the completion of the trial, the subjects will be treated at the Investigator’s discretion or referred to other local doctors according to standard practice.

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

2021-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-08-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-02-02

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