Clinical Trials Register

Summary
EudraCT Number:	2021-003543-16
Sponsor's Protocol Code Number:	LP0133-1528
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:	2021-12-15
Trial results	View 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

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

Étude de phase 3 de 24 semaines, randomisée, en aveugle de l'examinateur, contrôlée contre traitement actif, à 2 groupes parallèles, comparant l'efficacité et la sécurité d'un traitement par delgocitinib crème 20 mg/g deux fois par jour à un traitement par alitrétinoïne gélulesune fois par jour chez des participants adultes atteints d'eczéma chronique sévère des mains

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

Étude de 24 semaines comparant l'efficacité et la sécurité d'un traitement par delgocitinib crème 20 mg/g deux fois par jour à un traitement par alitrétinoïne capsules une fois par jour chez des participants adultes atteints d'eczéma chronique sévère des mains

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	+4553599323
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.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical
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.3.9.3	Other descriptive name	LEO 124249A, JTE052
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	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	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.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)
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.3.4	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.3.9.4	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	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.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)
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.3.4	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.3.9.4	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	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

Chronic Hand Eczema

Eczéma chronique des mains

E.1.1.1

Medical condition in easily understood language

Severe Hand Eczema

Eczéma sévère des mains

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.

Comparer l’efficacité et la qualité de vie liée à la santé du delgocitinib crème deux fois par jour par rapport à l’alitrétinoïne gélule une fois par jour, chez des patients adultes atteints d’ECM sévère

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.

Comparer la sécurité du delgocitinib crème deux fois par jour par rapport à l’alitrétinoïne gélules une fois par jour, chez des patients adultes atteints d’ECM sévère

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. Le participant doit avoir au moins 18 ans au moment de la signature du consentement éclairé.
2. Diagnostic d’ECM défini comme un eczéma des mains ayant persisté plus de 3 mois ou récidivé au moins deux fois au cours des 12 derniers mois.
3. Maladie évaluée comme sévère lors de la sélection et l’inclusion selon l’IGA-CHE (score IGA-CHE de 4).
4. Antécédents récents documentés de réponse insuffisante au traitement par CT (à tout moment au cours de l'année précédant la visite de sélection) ou traitement par CT non recommandé sur le plan médical pour d'autres raisons.
5. Le participant doit se conformer au protocole de soins cutanés non pharmacologiques standards, notamment éviter les irritants et allergènes connus et pertinents.
6. Les exigences en matière de contraception doivent être conformes aux réglementations locales relatives aux méthodes de contraception pour les participants aux études cliniques.

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. Maladie de peau concurrente sur les mains.
2. Dermatite atopique active nécessitant un traitement pharmacologique sur des zones autres que les mains et les pieds.
3. Psoriasis actif, quelle que soit sa localisation.
4. Eczéma hyperkératosique des mains associé à un antécédent de psoriasis, quelle que soit sa localisation.
5. Infection cliniquement significative sur les mains.
6. Participants ne pouvant pas recevoir d’alitrétinoïne.
7. Infection cliniquement significative au cours des 28 jours précédant l’inclusion qui, de l’avis de l’investigateur, pourrait compromettre la sécurité du participant lors de l’essai, interférer avec l'évaluation du ME, ou réduire la capacité du participant à participer à l’étude.
8. Antécédent de trouble d’immunodéficience primaire connu, y compris résultat positif au dépistage du virus de l’immunodéficience humaine (VIH) lors de la sélection, ou prise d’un traitement antirétroviral d'après les antécédents médicaux et/ou les déclarations du patient.
9. Tout trouble non stable et pouvant : a) affecter la sécurité du participant tout au long de l’étude b) empêcher le participant de terminer l’étude.
10. Résultat positif pour l'antigène de surface du virus de l’hépatite B (Ag HBs) ou à la sérologie des anticorps contre le virus de l'hépatite C (VHC) lors de la sélection.
11. Traitement systémique par médicaments immunosuppresseurs, immunomodulateurs, rétinoïdes, ou corticoïdes au cours des 28 jours précédant l’inclusion.
12. Utilisation de cabines de bronzage, photothérapie, ou de bains d’eau de Javel sur les mains au cours des 28 jours précédant l’inclusion.
13. Traitement antérieur ou en cours par inhibiteurs de JAK, systémique ou topique.
14. Traitement en application cutanée par immunomodulateurs ou CT sur les mains au cours des 14 jours précédant l’inclusion.
15. Utilisation d'antibiotiques systémiques ou en application cutanée sur les mains au cours des 14 jours précédant l’inclusion.
16. Autre traitement transdermique ou en application cutanée sur les mains (à l’exception de l’utilisation par le participant de ses propres émollients) au cours des 7 jours précédant l’inclusion.
17. Traitements en application cutanée sur des zones autres que les mains, pouvant interférer avec les évaluations de l'étude clinique ou poser un problème de sécurité, au cours des 7 jours précédant l’inclusion.
18. Traitement par un biomédicament commercialisé ou expérimental, à l’exception des vaccins :
a. Tout agent induisant une déplétion lymphocytaire, notamment le rituximab : au cours des 6 mois précédant l’inclusion, ou jusqu’à la normalisation de la numération lymphocytaire, selon la durée la plus longue.
b. Autres biomédicaments : au cours des 3 mois ou 5 demi-vies précédant l’inclusion, selon la période la plus longue.
19. Utilisation antérieure d’alitrétinoïne ou participation antérieure à un essai clinique utilisant de l’alitrétinoïne ou du delgocitinib.

E.5 End points

E.5.1

Primary end point(s)

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

Critère d'évaluation principal :
- Variation du score HECSI entre l’inclusion et la semaine 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

from baseline to Week 12

Entre l’inclusion et la semaine 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.

Critères d’évaluation secondaires majeurs :
• HECSI-90 (au moins 90% d'amélioration du score HECSI depuis l'inclusion) à la semaine 12.
• Evaluation globale par l'investigateur de la réussite du traitement contre l'eczéma chronique des mains© (IGA-CHE TS) à la semaine 12.
• Variation du score HESD pour les démangeaisons (moyenne hebdomadaire) entre l’inclusion et la semaine 12.
• Variation du score HESD pour la douleur (moyenne hebdomadaire) entre l’inclusion et la semaine 12.
• ASC pour la réponse HECSI-90 entre l’inclusion et la semaine 24.
• ASC pour la variation du DLQI entre l’inclusion et la semaine 24.
• Variation du score HECSI entre l’inclusion et la semaine 24.

Critères d'évaluation secondaires :
• Nombre d’EI apparus sous traitement entre l’inclusion et la semaine 26.
• Nombre d’EIG apparus sous traitement entre l’inclusion et la semaine 26.
• Nombre d’EI ayant entraîné l’arrêt du ME jusqu’à la semaine 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

from baseline up to Week 26

Entre l’inclusion et la semaine 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

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

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

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

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 date de fin d'étude est la date de la dernière visite du dernier participant à l'étude.

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.

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

2022-01-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-12-05

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IMP with orphan designation in the indication
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