Clinical Trials Register

Summary
EudraCT Number:	2021-003543-16
Sponsor's Protocol Code Number:	LP0133-1528
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:	2021-12-07
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

2021-003543-16

A.3

Full title of the trial

A 24 week, randomised, assessor blinded, active-controlled, parallel group, phase 3, 2 arm trial to compare the efficacy and safety of delgocitinib cream 20 mg/g twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema

Sperimentazione di fase 3, randomizzata, in cieco per il valutatore, con controllo attivo, a gruppi paralleli, a 2 bracci, della durata di 24 settimane per confrontare l’efficacia e la sicurezza di delgocitinib crema 20 mg/g due volte al giorno con alitretinoina capsule una volta al giorno in partecipanti adulti con eczema grave cronico della mano.

A.3.1

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

A 24 week trial to compare the efficacy and safety of delgocitinib cream 20 mg/g twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema

Sperimentazione della durata di 24 settimane per confrontare l’efficacia e la sicurezza di delgocitinib crema 20 mg/g due volte al giorno con alitretinoina capsule una volta al giorno in partecipanti adulti con eczema grave cronico della mano.

A.3.2

Name or abbreviated title of the trial where available

DELTA FORCE

A.4.1

Sponsor's protocol code number

LP0133-1528

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
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	Clinical Project Manager
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	2750
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004553599323
B.5.5	Fax number	0000000
B.5.6	E-mail	fmedk@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	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	Delgocitinib
D.3.2	Product code	[----]
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	Delgocitinib
D.3.9.1	CAS number	1263774-59-9
D.3.9.2	Current sponsor code	LEO 124249
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	20
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	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	Toctino
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline UK Limited (Trading as Stiefel) PL 19494/0253
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	00000000
D.3.2	Product code	[0000000]
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALITRETINOIN
D.3.9.1	CAS number	5300-03-8
D.3.9.2	Current sponsor code	--------
D.3.9.4	EV Substance Code	SUB00344MIG
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: 3
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	Toctino
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline UK Limited (Trading as Stiefel) PL19494/0252
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	-------------
D.3.2	Product code	[-----------------------]
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALITRETINOINA
D.3.9.1	CAS number	5300-03-8
D.3.9.2	Current sponsor code	-----------
D.3.9.4	EV Substance Code	SUB00344MIG
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	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

Chronic Hand Eczema

Eczema cronico della mano

E.1.1.1

Medical condition in easily understood language

Severe Hand Eczema

Eczema grave della mano

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	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084778
E.1.2	Term	Chronic hand eczema
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

To compare the efficacy and health-related quality of life of twice-daily topical application of delgocitinib cream with once-daily oral administration of alitretinoin capsules in the treatment of patients with severe CHE.

confrontare l’efficacia e la qualità della vita correlata alla salute dell’applicazione topica due volte al giorno di delgocitinib crema con la somministrazione orale una volta al giorno di alitretinoina capsule nel trattamento di pazienti con CHE grave.

E.2.2

Secondary objectives of the trial

To compare the safety of twice-daily topical application of delgocitinib cream with once-daily oral administration of alitretinoin capsules in the treatment of patients with severe CHE.

Confrontare la sicurezza dell’applicazione topica due volte al giorno di delgocitinib crema con la somministrazione orale una volta al giorno di alitretinoina capsule nel trattamento di pazienti con CHE grave

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participant must be at least 18 years of age inclusive, at the time of
signing the informed consent
2. Diagnosis of CHE defined as hand eczema that has persisted for more
than 3 months or returned twice or more within the last 12 months.
3. Disease severity graded as severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 4).
4. Documented recent history of inadequate response to treatment with TCS (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable
5. Participant is adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
6. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

1. Il partecipante deve avere almeno 18 anni compresi, al momento della firma del consenso informato
2. Diagnosi di CHE definito come eczema della mano che persiste da un tempo superiore a più di 3 mesi o ripresentatosi due o più volte negli ultimi 12 mesi.
3. Gravità della malattia classificata come grave allo screening e al basale secondo IGA-CHE (es un punteggio IGA-CHE di 4).
4. Storia recente documentata di risposta inadeguata al trattamento con TCS (in qualsiasi momento entro 1 anno prima della visita di screening) o per i quali i TCS sono documentati essere altrimenti sconsigliati dal punto di vista medico
5. Il partecipante aderisce alla cura standard non medicata della pelle, incluso l'evitare irritanti e allergeni noti e rilevanti.
6. L'uso di contraccettivi deve essere coerente con le normative locali in materia di metodi di contraccezione per coloro che partecipano a studi clinici.

E.4

Principal exclusion criteria

1. Concurrent skin diseases on the hands.
2. Active atopic dermatitis requiring medical treatment in regions other than the hands and feet.
3. Active psoriasis on any part of the body.
4. Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
5. Clinically significant infection on the hands.
6. Participants who cannot receive alitretinoin
7. Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with the evaluation of the IMP, or reduce the participant's ability to participate in the trial.
8. History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
9. Any disorder that is not stable and could: a) Affect the safety of the participant throughout the trial b) Impede the participant's ability to complete the trial.
10. Positive HBsAg or HCV antibody serology at screening.
11. Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline.
12. Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline.
13. Previous or current treatment with JAK inhibitors, systemic or topical.
14. Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days prior to baseline.
15. Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
16. Other transdermal and cutaneously applied therapy on the hands (except for the use of participant's own emollients) within 7 days prior to baseline.
17. Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern, within 7 days prior to baseline.
18. Treatment with any marketed biological therapy or investigational biologic agents, except vaccines:a. Any cell-depleting agents including but not limited to rituximab:
within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. b. Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
19. Previously used alitretinoin or participated in a clinical trial with alitretinoin or delgocitinib.

1. Malattie concomitanti della pelle delle mani.
2. Dermatite atopica attiva che richiede cure mediche in altre regioni rispetto alle mani e ai piedi.
3. Psoriasi attiva su qualsiasi parte del corpo.
4. Eczema ipercheratosico della mano in combinazione con una storia di psoriasi su qualsiasi parte del corpo.
5. Infezione clinicamente significativa sulle mani.
6. Partecipanti che non possono ricevere l'alitretinoina
7. Infezione clinicamente significativa entro 28 giorni prima del basale che,a parere dello sperimentatore, può compromettere la sicurezza del partecipante alla sperimentazione, interferire con la valutazione dell'IMP, o ridurre la capacità del partecipante di partecipare alla sperimentazione.
8. Storia di qualsiasi disturbo da immunodeficienza primaria noto, incluso test HIV positivo allo screening, o il partecipante che assume farmaci antiretrovirali come determinato dall'anamnesi e/o riferito verbalmente dai partecipanti
9. Qualsiasi disturbo non stabile e che possa: a) compromettere la sicurezza del partecipante durante lo studio b) Impedire la capacità del partecipante di
completare lo studio.
10. Sierologia degli anticorpi HBsAg o HCV positiva allo screening.
11. Trattamento sistemico con farmaci immunosoppressori, farmaci immunomodulatori, retinoidi o corticosteroidi entro 28 giorni prima del basale.
12. Uso di lettini abbronzanti, fototerapia o bagni di candeggina sulle mani entro 28 giorni prima del basale.
13. Trattamento precedente o in corso con inibitori JAK, sistemici o topici.
14. Trattamento cutanoe applicato con immunomodulatori o TCS sulle mani entro 14 giorni prima del basale.
15. Uso di antibiotici sistemici o antibiotici applicati per via cutanea sulle mani entro 14 giorni prima della linea del basale.
16. Altra terapia transdermica e cutanea applicata sulle mani (ad eccezione dell'uso di emollienti propri del partecipante) entro 7 giorni prima del basale.
17. Trattamenti cutanei applicati in regioni diverse dalle mani, che potrebbero interferire con le valutazioni dello studio clinico o rappresentare una preuccupazione di sicurezza, entro 7 giorni prima dal basale .
18. Trattamento con qualsiasi terapia biologica commercializzata o agenti biologici sperimentali, esclusi i vaccini:
A. Qualsiasi agente di deplezione cellulare incluso ma non limitato a rituximab: entro 6 mesi prima del basale o fino a quando la conta dei linfociti ritorna normale, qualunque sia più lungo.
B. Altri farmaci biologici: entro 3 mesi o 5 emivite, a seconda di quale sia più lunga,prima del basale.
19. Alitretinoina usata in precedenza o partecipazione ad uno studio clinico con alitretinoina o delgocitinib.

E.5 End points

E.5.1

Primary end point(s)

Change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12.

Variazione del punteggio HECSI dal basale alla Settimana 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

from baseline to Week 12

Dal basale alla settimana 12

E.5.2

Secondary end point(s)

Key secondary endpoints:
• HECSI-90 (at least 90% improvement in HECSI score from baseline) at Week 12.
• Investigator's Global Assessment for chronic hand eczema© treatment success (IGA-CHE TS) at Week 12.
• Change in Hand Eczema Symptom Diary© (HESD) itch score (weekly average) from baseline to Week 12.
• Change in HESD pain score (weekly average) from baseline to Week 12.
• AUC of HECSI-90 from baseline up to Week 24.
• AUC of change from baseline in Dermatology Life Quality Index (DLQI) score up to Week 24.
• Change in HECSI score from baseline to Week 24.

Secondary endpoints:
• Number of treatment-emergent AEs from baseline up to Week 26.
• Number of treatment-emergent SAEs from baseline up to Week 26.
• Number of AEs leading to IMP discontinuation up to Week 24.

End Points secondari chiave
• HECSI-90 ( almeno 90% di migliramento nel punteggio HECSI dal basale) alla Settimana 12.
• IGA-CHE TS alla Settimana 12.
• Variazione del punteggio HESD del prurito (media settimanale) dal basale alla Settimana 12.
• Variazione del punteggio HESD del dolore (media settimanale) dal basale alla Settimana 12.
• AUC di HECSI-90 dal basale alla Settimana 24.
• AUC della variazione del punteggio DLQI dal basale alla Settimana 24.
• Variazione del punteggio HECSI dal basale alla Settimana 24

End points secondari
• Numero di EA emergenti dal trattamento dal basale fino alla Settimana 26.
• Numero di SAE emergenti dal trattamento dal basale fino alla Settimana 26.
• Numero di EA che comportano l’interruzione dell’IMP fino alla Settimana 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

from baseline up to Week 26

Dal basale sino alla settimana 26

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

Health Related Quality of Life

Qualità della vita correlata alla salute

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

Yes

E.8.1.7.1

Other trial design description

valutatore in cieco

Assessor blinded

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

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

Austria

Canada

Germany

Italy

Poland

Spain

United Kingdom

France

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 the trial is defined as the date of the last visit of the last participant in the trial.

La fine dello studio è definita come la data dell'ultima visita dell'ultimo partecipante allo sperimentazione.

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:

459

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

439

F.4.2.2

In the whole clinical trial

510

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 end of the trial, participants will be treated at the investigator's discretion or referred to other physician(s) according to standard practice.

Dopo la fine della sperimentazione, i partecipanti saranno trattati a discrezione dello sperimentatore o indirizzati ad altri medici in base alla pratica standard.

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

2022-02-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-01-12

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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