Clinical Trials Register

Summary
EudraCT Number:	2021-004349-18
Sponsor's Protocol Code Number:	M-14789-41
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-09-14
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

2021-004349-18

A.3

Full title of the trial

A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients with Actinic Keratosis on the Face or Scalp.

Studio di fase IV multicentrico, randomizzato, con valutatore in cieco, controllato in attivo, per determinare l'incidenza del carcinoma squamocellulare e valutare la sicurezza a lungo termine di tirbanibulina 10 mg/g unguento e diclofenac sodico 3% gel per il trattamento di pazienti adulti affetti da cheratosi attinica del viso o del cuoio capelluto.

A.3.1

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

Long-term clinical safety study to evaluate the risk that actinic keratosis may progress to skin cancer of the face or scalp in adult patients treated with tirbanibulin and diclofenac.
Actinic keratosis is a precancerous condition characterized by abnormal skin growth following excessive exposure to sunlight.

Studio di sicurezza clinica a lungo termine volto a valutare il rischio che la cheratosi attinica possa progredire in cancro della pelle del viso o del cuoio capelluto in pazienti adulti trattati con tirbanibulina e diclofenac.
La cheratosi attinica è una condizione precancerosa caratterizzata da crescita anormale della pelle a seguito di un'eccessiva esposizione alla luce solare.

A.3.2

Name or abbreviated title of the trial where available

ALM1061

A.4.1

Sponsor's protocol code number

M-14789-41

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	Almirall SA
B.1.3.4	Country	Spain
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	Almirall, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Almirall, S.A.
B.5.2	Functional name of contact point	Internat. Clinical Trial Manager
B.5.3	Address:
B.5.3.1	Street Address	Ronda General Mitre 151
B.5.3.2	Town/ city	Barcellona
B.5.3.3	Post code	08022
B.5.3.4	Country	Spain
B.5.6	E-mail	gco@almirall.com

D. IMP Identification
D.IMP: 1
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	SOLARAZE - 1 TUBO 25 G DI GEL 3%
D.2.1.1.2	Name of the Marketing Authorisation holder	ALMIRALL S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Solaraze 3% gel
D.3.2	Product code	[NA]
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	DICLOFENAC SODICO
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Diclofenac Sodium
D.3.9.4	EV Substance Code	SUB01674MIG
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	30
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	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	Klisyri
D.2.1.1.2	Name of the Marketing Authorisation holder	Almirall, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Klisyri 10 mg/g unguento
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Ointment
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	Tirbanibulina
D.3.9.2	Current sponsor code	KX2-391
D.3.9.3	Other descriptive name	Tirbanibulin
D.3.9.4	EV Substance Code	SUB198081
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	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Actinic Keratosis on the Face or Scalp

Cheratosi attinica sul viso o sul cuoio capelluto

E.1.1.1

Medical condition in easily understood language

Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight.

La cheratosi attinica è una crescita cutanea precancerosa e anormale che si sviluppa dopo un'eccessiva esposizione alla luce solare.

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	PT
E.1.2	Classification code	10000614
E.1.2	Term	Actinic keratosis
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 incidence of biopsy confirmed invasive SCC in the selected TF after administration of topical tirbanibulin 10 mg/g ointment or diclofenac sodium 3% gel over the 3-year study period.

Valutare l'incidenza dell'SCC invasivo confermato mediante biopsia nel TF selezionato dopo la somministrazione di tirbanibulina 10 mg/g unguento o diclofenac sodico 3% gel nel corso del periodo di studio di 3 anni.

E.2.2

Secondary objectives of the trial

To evaluate the safety of topical tirbanibulin 10 mg/g ointment and diclofenac sodium 3% gel over the 3-year study period

Valutare la sicurezza di tirbanibulina 10 mg/g unguento e diclofenac sodico 3% gel nel corso del periodo di studio di 3 anni.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female and =18 years old.
2. A TF on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that:
• Is a contiguous area measuring 25 cm2,
• Contains 2 to 8 clinically typical, visible, and discrete AK lesions, and
• Has an overall clinical picture that is consistent with Olsen grade 1.
3. If a WOCBP, ie, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months prior to Screening), she must:
• Have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration.
• Be using effective methods of birth control.
• Agree to have pregnancy tests while in the study and at the end of the study (according to the Schedule of Assessments in Table 1).
4. Patients should be willing to avoid sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study.
5. Patients should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines.

1. Sesso maschile o femminile ed età =18 anni.
2. Tricofolliculoma (TF) sul viso o sul cuoio capelluto (escluse labbra, palpebre, orecchie e interno delle narici) che:
• Sia costituito da un'area contigua di 25 cm2;
• Contenga da 2 a 8 lesioni da cheratosi attinica (actinic keratosis, AK) separate, visibili e tipiche, visibili e dal punto di vista clinico, e
• Presenti un quadro clinico generale coerente con il grado 1 di Olsen
Se una paziente è in età fertile, ovvero si trova nel periodo di vita compreso tra il menarca e la post-menopausa (definita come assenza di mestruazioni per 12 mesi senza una causa
medica alternativa) o la sterilizzazione permanente (mediante isterectomia, salpingectomia bilaterale o ovariectomia bilaterale almeno 3 mesi prima dello screening), deve:
• Presentare un test di gravidanza sulle urine negativo eseguito mediante un metodo altamente sensibile allo screening e il Giorno 1 prima della somministrazione del trattamento.
• Utilizzare metodi contraccettivi efficaci.
• Accettare di sottoporsi a test di gravidanza durante lo studio e alla fine dello studio( secondo il Programma delle valutazioni di cui alla Tabella 1).
4. I pazienti devono essere disposti ad evitare l'esposizione alla luce solare o ai raggi UV sul viso o sul cuoio capelluto durante lo studio, compreso l'uso di lettini abbronzanti.
5. I pazienti devono essere in grado di comprendere lo scopo e i rischi dello studio e devono essere disposti a rispettare il protocollo e fornire il consenso informato scritto in conformità con le linee guida istituzionali e normative.

E.4

Principal exclusion criteria

1. The location of the TF is:
a) On any location other than the face or scalp.
b) Within 5 cm of an incompletely healed wound.
c) Within 10 cm of a suspected basal cell carcinoma or other neoplasm.
d) On the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils.
2. Presence in the TF of:
a) Clinically atypical and/or rapidly changing AK lesions
b) Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery onc2 previous occasions), and/or cutaneous horn.
c) Confluent AK lesions (ie, non-discrete lesions, as per inclusion criterion 2).
d) Persisting AK lesions at the screening visit following topical treatment with diclofenac sodium 3% gel.
3. History of any malignant skin tumour in the TF or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely.
4. History of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the Screening Visit or systemic antitumor treatment is expected while on the study.
5. Immunocompromised patients, including patients with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients.
6. Any other dermatological disease that causes difficulty with examination within the treatment area.
7. Anticipated need for inpatient hospitalization or inpatient surgery during the study.
8. Previous treatment with tirbanibulin 10 mg/g ointment in the selected TF.
9. Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other topical treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening Visit.
10. Use of the following therapies and/or medications within 4 weeks prior to the Screening Visit:
a) Treatment with cytotoxic drugs.
b) Treatment with systemic medications that modulate and/or suppress the immune system
c) Use of systemic retinoids
11. Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit:
a) Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the TF or within a 2 cm margin of the selected TF.
b) Acid-containing therapeutic products, topical retinoids, or light chemical peels within the TF or within a 2 cm margin of the selected TF.
c) Topical steroids within the TF or within a 2 cm margin of the selected TF.
d) Artificial tanners within the TF or within a 5 cm margin of the selected TF.
12. History of sensitivity and/or allergy to any of the ingredients in the study medications to tirbanibulin, diclofenac, or nonsteroidal antiinflammatory drugs (ie, NSAIDs).
13. A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the patient to unacceptable risk by study participation.
14. Significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the patient to unacceptable risk by study participation.
15. Females who are pregnant or nursing or who are intending to become pregnant
16. Participated in an investigational drug study during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to
screening
17. Patient who is an employee or a relative to an employee at the research site or Almirall

1. Il TF si trova:
a) In qualsiasi sito diverso dal viso o dal cuoio capelluto.
b) Entro 5 cm da una lesione non completamente guarita.
c) Entro 10 cm da un sospetto carcinoma basocellulare o altra neoplasia.
d) Sulle labbra, palpebre, orecchie o all'interno delle narici, in sede periorbitale o periorale o sulla cute attorno alle narici
2. Presenza nel TF di:
a) Lesioni da AK atipiche dal punto di vista clinico e/o in rapida evoluzione.
b) Lesioni ipercheratosiche o ipertrofiche, malattia recalcitrante (criochirurgia in 2 occasioni precedenti) e/o corno cutaneo.
c) Lesioni da AK confluenti (cioè, lesioni non separate, secondo il criterio di inclusione 2).
d) Lesioni da AK persistenti alla visita di screening dopo il trattamento topico con diclofenac sodico 3% gel.
3. Anamnesi di tumore cutaneo maligno nel TF o anamnesi di tumore cutaneo in qualsiasi regione del corpo che ha metastatizzato o che è probabile che metastatizzi durante il periodo di studio.
4. Anamnesi di tumore maligno trattato con terapia antitumorale sistemica (inclusa la radioterapia) nelle 12 settimane precedenti alla visita di screening o per il quale è previsto l'avvio di un trattamento antitumorale sistemico durante lo studio.
5. Pazienti immunocompromessi, inclusi pazienti con anamnesi di linfoma sistemico cronico o leucemia mieloide cronica o pazienti che hanno ricevuto un trapianto d'organo.
6. Qualsiasi altra malattia dermatologica che ostacola l'esame dell'area di trattamento.
7. Necessità prevista di ricovero ospedaliero o intervento chirurgico con ricovero durante lo studio.
8. Precedente trattamento con tirbanibulina 10 mg/g unguento del TF selezionato.
9. Trattamento con 5-fluorouracile, imiquimod, ingenolo mebutato, diclofenac, terapia fotodinamica o altri trattamenti topici per l'AK all'interno del TF o entro 2 cm dal TF, nelle 8 settimane precedenti alla visita di screening.
10. Uso delle seguenti terapie e/o farmaci nelle 4 settimane precedenti alla visita di screening:
a) Trattamento con farmaci citotossici.
b) Trattamento con farmaci sistemici che modulano e/o sopprimono il sistema immunitario.
c) Uso di retinoidi sistemici.
11. Uso delle seguenti terapie e/o farmaci nelle 2 settimane precedenti alla visita di screening:
a) Procedure estetiche o terapeutiche (ad es. uso di azoto liquido, escissione chirurgica, etc.) all'interno del TF o entro un margine di 2 cm dal TF selezionato.
b) Prodotti terapeutici contenenti acidi (ad es. acido salicilico o acidi della frutta, come gli alfa e beta-idrossiacidi e gli acidi glicolici), retinoidi topici o peeling chimici leggeri all'interno del TF o entro un margine di 2 cm dal TF selezionato.
c) Steroidi topici all'interno del TF o entro un margine di 2 cm dal TF selezionato.
d) Abbronzanti artificiali all'interno del TF o entro un margine di 5 cm dal TF selezionato.
12. Anamnesi di sensibilità e/o allergia a uno qualsiasi degli ingredienti dei farmaci in studio, alla tirbanibulina, al diclofenac o ai farmaci antinfiammatori non steroidei (FANS).
13. Patologia cutanea (ad es. dermatite atopica, psoriasi, eczema) o condizione cutanea (ad es. cicatrici, ferite aperte) che, secondo il giudizio dello sperimentatore, potrebbe interferire con lo svolgimento o le valutazioni dello studio o esporre il paziente a rischi inaccettabili associati alla partecipazione allo studio.
14. Patologie o condizioni mediche significative non controllate o instabili che, secondo il giudizio dello sperimentatore, esporrebbero il paziente a rischi inaccettabili associati alla partecipazione allo studio.
15. Donne in gravidanza o in allattamento o che intendono avviare una gravidanza.
16. Partecipazione a uno studio in cui al paziente è stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite del prodotto sperimentale prima dello screening, a seconda di quale sia il periodo più lungo.
17. Paziente che è un dipendente o un parente di un dipendente del centro di ricerca o di Almirall.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with histologically confirmed invasive SCC in the TF over the 3-year study period.

Percentuale di pazienti con SCC invasivo confermato istologicamente nel TF nel corso del periodo di studio di 3 anni.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 years

3 anni

E.5.2

Secondary end point(s)

• AEs and SAEs over 3 years
• Proportion of patients with any other skin cancer (other than SCC) in the TF over the 3-year study period.
• Time to occurrence of invasive SCC from baseline in the TF.
• Proportion of patients requiring rescue treatment after 1 treatment course.
• Proportion of patients requiring rescue treatment at any time during the study.
• Proportion of patients with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks.
• Other safety assessments (vital signs, PE) over 3 years

• AE e SAE nell'arco di 3 anni.
• Percentuale di pazienti con altre forme tumorali cutanee (diverse dall'SCC) nel TF nel corso del periodo di studio di 3 anni.
• Tempo dal basale all'insorgenza dell'SCC invasivo nel TF.
• Percentuale di pazienti che richiedono un trattamento di soccorso dopo 1 ciclo di trattamento.
• Percentuale di pazienti che richiedono un trattamento
di soccorso in qualsiasi momento durante lo studio.
• Percentuale di pazienti che non presentano lesioni dopo il trattamento della prima recidiva con tirbanibulina durante le prime 52 settimane.
• Altre valutazioni di sicurezza (segni vitali, esame obiettivo [EO]) nell'arco di 3 anni.

E.5.2.1

Timepoint(s) of evaluation of this end point

From the beginning to the end of the study

Dall'inizio al termine dello studio

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

Yes

E.6.13.1

Other scope of the trial description

Incidence

Incidenza

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Diclofenac sodico 3% gel

Diclofenac sodium 3% gel

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

France

Poland

Spain

Germany

Italy

United Kingdom

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

Last Visit of the Last Patient

Ultima Visita dell'Ultimo Paziente

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.1.2.1

Number of subjects for this age range:

190

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

350

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

528

F.4.2.2

In the whole clinical trial

540

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)

Patients will continue to followed up according to the standard rules established by good clinical practice.

I pazienti continueranno ad essere seguiti secondo le norme standard previste dalla buona pratica clinica.

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

2022-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-07-20

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
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