Clinical Trials Register

Summary
EudraCT Number:	2011-001697-26
Sponsor's Protocol Code Number:	055-006
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-06
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-001697-26

A.3

Full title of the trial

Optimisinf outpatient care in mild to moderate psoriasis by a newly developed ''Topical Treatment Optimising Programme'' - an international study using Daivobet/Dovobet Gel (PSO-TOP)

Ottimizzazione della terapia nel paziente affetto da psoriasi lieve a moderata in base ad un Programma per l'Ottimizzazione della Terapia Topica definito nell'ambito dello studio internazionale che prevede l'utilizzo di Daivobet/Dovobet Gel (PSO-TOP)

A.3.1

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

optomising of a topical treatment in patients with mild to moderate psoriasis in an international study

ottimizzazione di una terapia topica in pazienti con psoriasi da lieve a moderata nell'ambito di uno studio internazionale

A.4.1

Sponsor's protocol code number

055-006

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	SCIDERM 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	LEO PHARMA
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	DIMENSIONE RICERCA SRL
B.5.2	Functional name of contact point	DIREZIONE GENERALE
B.5.3	Address:
B.5.3.1	Street Address	VIALE DEI PARIOLI 12
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00197
B.5.3.4	Country	Italy
B.5.4	Telephone number	0680693528
B.5.5	Fax number	0680693521
B.5.6	E-mail	s.marini@dimensione-ricerca.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	DOVOBET*GEL FL 60G
D.2.1.1.2	Name of the Marketing Authorisation holder	PRODOTTI FORMENTI Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Gel
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
D.3.9.1	CAS number	112828-00-9
D.3.9.4	EV Substance Code	SUB06046MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	5593-20-4
D.3.9.4	EV Substance Code	SUB00783MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	.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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

PATIENTS WITH MILD TO MODERATE PSORIASIS

PAZIENTI CON PSORIASI DA LIEVE A MODERATA

E.1.1.1

Medical condition in easily understood language

PSORIASIS

PSORIASI

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	14.0
E.1.2	Level	PT
E.1.2	Classification code	10037153
E.1.2	Term	Psoriasis
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 ASSESS THE VALUE OF THE TOPICAL TREATMENT OPTIMISING PROGRAMME IN THE TOPICAL TREATMENT OF INSUFFICIENTLY TREATED MILD TO MODERATE PSORIASIS AFTER 8 WEEKS OF ONCE DAILY TREATMENT WITH DAIVOBET/ DOVOBET GEL

CONTROLLARE LA VALIDITA' DEL PROGRAMMA OTTIMIZZAZIONE (pso-top) NELLA TERAPIA TOPICA DELLA PSORIASI, LIEVE A MODERATA, NON TRATTATA ADEGUATAMENTE, DOPO 8 SETTIMANE DI APPLICAZIONE GIORNALIERA DI DAIVOBET/DOVOBET GEL

E.2.2

Secondary objectives of the trial

To assess the value of the ‘Topical Treatment Optimising Programme’ in the topical treatment of insufficiently treated mild to moderate psoriasis every 8 weeks over a treatment period of 64 weeks. To assess the usefulness of a ‘Topical Therapy Questionnaire’ and ‘Patient’s self Global Assessment’ in the assessment of patient reported outcomes and in comparison to available tools. To assess the value of the ‘Topical Treatment Optimising Programme’ in country-specific subanalyses. To compare the drop-out rates after 64 weeks of treatment between the two study arms (‘Topical Treatment Optimising Programme’ versus ‘non- Topical Treatment Optimising Programme’) To compare the consumption of Daivobet/Dovobet Gel between the two study arms during the maintenance phase of the study To confirm long term efficacy and safety of the study medication

CONTROLLARE LA VALIDITA' DEL PROGRAMMA DI OTTIMIZZAZIONE DELLA TERAPIA TOPICA OGNI 8 SETTIMANE PER UN PERIODO TOTALE DI TERAPIA DI 64 SETTIMANE; VALUTARE L'UTILITA' DEI QUESTIONARI DI AUTOVALUTAZIONE GENERALE, CONFRONTANDOLICON STRUMENTI GIA' ESISTENTI;CONTROLLARE LA VALIDITA' DEL PROGRAMMA PER L'OTTIMIZZAZIONE DELLA TERAPIA IN SUB-AMALISI SPECIFICHE SU BASE NAZIONALE; CONFRONTARE LE PERCENTUALI DI DROP-OUTS DOPO 64 SETTIMANE DI TERAPIA NEL GRUPPO DI PAZIENTI CHE SEGUE IL PROGRAMMA PER L'OTTIMIZZAZIONE DELLA TERAPIA TOPICA RISPETTO AL GRUPPO INSERITO NELLA TERAPIA STANDARD; CONFRONTARE IL CONSUMO QUANTITATIVO DI DAIVOBET/DOVOBET GEL TRA I GRUPPI DI PAZIENTI STUDIATI; CONFERMARE L'EFFICACI A LUNGO TERMINE E LA SICUREZZA DEL PRODOTTO IN STUDIO.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male and female patients aged at least 18 years - Mild to moderate active plaque psoriasis with a PGA ≥ 2 on the 7 point scale by Langley and Ellis and a Body Surface Area (BSA) of ≤ 10% - Topical psoriasis treatment with steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol / 0.5 mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)

Pazienti in età adulta (Uomini e donne) età > 18 anni - Psoriasi a placche, da lieve a moderata, con PGA (Physician’s Global Assessment) ≥ 2 su scala apunti 7 di Langley ed Ellis ed una Body Surface Area (BSA) ≤ 10% - Terapia topica della psoriasi con preparati al carbone o catrame, tazarotene, steroidi, o analoghi della vitamina D, o combinazioni di steroidi e analoghi della vitamina D (tranne prodotti con combinazione di gel contenenti 50 microgrammi calcipotriolo / 0.5 mg betametasone/g) o ditranolo e sue preparazioni in associazione, nelle ultime 8 settimane antecedenti la Visita 1 (settimana 0)

E.4

Principal exclusion criteria

- Severe renal insufficiency - Severe hepatic disorders - Known disorders in calcium metabolism - Erythrodermic, exfoliative, pustular or guttate psoriasis - Facial or genital psoriasis - Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet/Dovobet Gel - Pregnant or breast-feeding women - Hypersensitivity to the active substances or to any of the excipients - Suspected non-compliance - Current participation in another clinical study - Systemic treatment of plaque psoriasis over the last 8 weeks prior to Visit 1 (week 0) - Phototherapy during the last 4 weeks prior to Visit 1 (week 0)

- Grave insufficienza renale - Gravi disturbi epatici - Iper calcemia conclamata - Psoriasi eritrodermica, esfoliativa, pustolosa o guttata - Psoriasi faciale o genitale - Esistenza di almeno una controindicazione indicata nel Foglio illustrativo del Daivobet/Dovobet Gel - Donne in gravidanza e/o allattamento - Ipersensibilità ai principi attivi o a uno qualsiasi degli eccipienti - Mancato rispetto delle procedure dello studio clinico - Partecipazione contemporanea in altro studio clinico - Terapia sistematica con farmaci biologici, sia in commercio che in sperimentazione, con un possibile effetto sulla psoriasi entro i seguenti periodi antecedenti alla Visita 1 (settimana 0), indicati di seguito: • etanercept – entro le 4 settimane antecedenti la Visita 1 (settimana 0) • adalimumab, alefacept, infliximab – entro i 2 mesi antecedenti la Visita 1 (settimana 0) • ustekinumab – entro i 4 mesi antecedenti la Visita 1 (settimana 0) • prodotti sperimentali – entro le 4 settimane /5 emivite del prodotto (quale che sia il periodo più lungo) antecedenti la Visita 1 (settimana 0) - Fototerapia entro i seguenti periodi antecedenti la Visita 1 (settimana 0), indicati di seguito: • PUVA – entro le 4 settimane antecedenti la Visita 1 (settimana 0) • UV-B – entro le 2 settimane antecedenti la Visita 1 (settimana 0)

E.5 End points

E.5.1

Primary end point(s)

Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 at week 8

Percentuale di pazienti con PGA pari a 0 o 1 alla settimana 8

E.5.1.1

Timepoint(s) of evaluation of this end point

WEEK 8

SETTIMANA 8

E.5.2

Secondary end point(s)

Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 at weeks 16 to 64 (documented at intervals of 8 weeks) Mean PGA and BSA at weeks 8 to 64 (documented at intervals of 8 weeks) EQ-5D and DLQI at weeks 0, 8, 32 and 64 Exploratory Patient Reported Outcomes: TTQ and PsGA at weeks 0, 8, 32 and 64. Rate of patients reaching a PsGA score of 0 or 1 at weeks 8 to 64 in the single countries (documented at intervals of 8 weeks) Mean weight of used study medication at weeks 4 to 64 (documented at intervals of 4 to 8 weeks) Drop-out rate per study arm at week 64 Rates of AEs and SAEs

Percentuale di pazienti con un PGA pari a 0 o 1 nelle settimane da 16 a 64 (documentati a intervalli di 8 settimane) PGA e BSA medie nelle settimane da 8 a 64 (documentate ad intervalli di 8 settimane) EQ-5D, EQ-VAS e DLQI nelle settimane 0, 8, 32 e 64 Percentuale di pazienti che raggiungono un DLQI ≤ 5 nelle settimane 0, 8, 32 e 64 Risultati Relativi al giudizio dei pazienti: TTQ, PPQ e PsGA nelle settimane 0, 8, 32 e 64 Risultati della classificazione del TTOP da parte del paziente (solo TTOP gruppo studiato) nelle settimane 8 e 64 Percentuale di pazienti che raggiungono un punteggio PsGA pari a 0 o 1 nelle settimane dalla 8 alla 64 nei singoli Paesi (documentata ad intervalli di 8 settimane) Giornate di assenza dal lavoro/studio a causa della psoriasi Peso medio del farmaco restituito nelle settimane dalla 4 alla 64 (documentato ad intervalli da 4 fino a 8 settimane) Percentuale di drop-out per gruppo di pazienti studiati alla settimana 64 Percentuali di Eventi Avversi anche gravi.

E.5.2.1

Timepoint(s) of evaluation of this end point

WEEK 8,32 AND 64

SETTIMANA 8,32 E 64

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

Improvement of patient compliance

Miglioramento della compliance

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

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

STESSO FARMACO SENZA QUESTIONARIO

SAME DRUG WITHOUT QUESTIONNARIE

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

130

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 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

Number of subjects for this age range:

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:

978

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

978

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

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

315

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1956

F.4.2.2

In the whole clinical trial

1956

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)

ADVERSE AVENTS (AEs AND SAEs) WILL BE DOCUMENTED FOR EACH PATIENT TROUGHOUT THE STUDY

SARANNO DOCUMENTATI GLI EVENTI AVVERSI E EVENTI AVVERSI GRAVI DURANTE TUTTA LA DURATA DELLO STUDIO

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

2012-03-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-06-25

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