Clinical Trials Register

Summary
EudraCT Number:	2022-003024-41
Sponsor's Protocol Code Number:	20190531
National Competent Authority:	Greece - EOF
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2023-01-20
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

Greece - EOF

A.2

EudraCT number

2022-003024-41

A.3

Full title of the trial

A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis

Μια Πολυκεντρική, Ανοιχτού Σχεδιασμού, Μακροχρόνια Δοκιμή Επέκτασης Φάσης 3 της Απρεμιλάστης σε Παιδιά Ηλικίας 2 Ετών και Άνω με Στοματικά Έλκη που σχετίζονται με τη Νόσο Αδαμαντιάδη-Behçet ή σε Παιδιά Ηλικίας 5 Ετών και Άνω με Νεανική Ψωριασική Αρθρίτιδα

A.3.1

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

Apremilast study in children with active oral ulcers associated with
Behçet's Disease or Juvenile Psoriatic Arthritis

Μια Ανοιχτού Σχεδιασμού, Παιδιατική Μακροχρόνια Δοκιμή Επέκτασης Φάσης 3 της Απρεμιλάστης σε Παιδιά με Στοματικά Έλκη που Σχετίζονται με τη Νόσο Αδαμαντιάδη- Behçet ή Νεανική Ψωριασική Αρθρίτιδα

A.4.1

Sponsor's protocol code number

20190531

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/353/2022

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Amgen Inc
B.1.3.4	Country	United States
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	Amgen Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amgen Hellas Ltd.
B.5.2	Functional name of contact point	Medical Information
B.5.3	Address:
B.5.3.1	Street Address	59-61 Agiou Konstantinou, Building C'
B.5.3.2	Town/ city	Marousi, Athens
B.5.3.3	Post code	GR 15124
B.5.3.4	Country	Greece
B.5.4	Telephone number	+302103447000
B.5.5	Fax number	+302103447050
B.5.6	E-mail	medinfo-amgen-hellas@amgen.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	Otezla
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Apremilast 20 mg
D.3.2	Product code	AMG 407
D.3.4	Pharmaceutical form	Film-coated tablet
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	Apremilast
D.3.9.1	CAS number	608141-41-9
D.3.9.2	Current sponsor code	AMG 407
D.3.9.4	EV Substance Code	SUB130837
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	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	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	Otezla
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Apremilast 30 mg
D.3.2	Product code	AMG 407
D.3.4	Pharmaceutical form	Film-coated tablet
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	Apremilast
D.3.9.1	CAS number	608141-41-9
D.3.9.2	Current sponsor code	AMG 407
D.3.9.4	EV Substance Code	SUB130837
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	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	Apremilast
D.3.2	Product code	AMG 407
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	Apremilast
D.3.9.1	CAS number	608141-41-9
D.3.9.2	Current sponsor code	AMG 407
D.3.9.4	EV Substance Code	SUB130837
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	Yes
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

Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis

Ασθενείς με στοματικά έλκη που σχετίζονται με τη Νόσο Αδαμαντιάδη ή Νεανική Ψωριασική Αρθρίτιδα

E.1.1.1

Medical condition in easily understood language

Behçet Disease: inflammation in blood vessels throughout the body, manifests as mouth or genital ulcers with eye & skin lesions
JPA:Joint inflammation with psoriatic disorder affecting pediatric pts

Νόσος Αδαμαντιάδη: φλεγμονή στα αιμοφόρα αγγεία σε όλο το σώμα, εκδηλώνεται ως έλκη στόματος ή γεννητικών οργάνων με οφθαλμικές & δερματικές βλάβες. Παρακαλώ ανατρέξετε στο πρωτοκολλο.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10004212
E.1.2	Term	Behcet's disease
E.1.2	System Organ Class	100000004866

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10079454
E.1.2	Term	Systemic juvenile idiopathic arthritis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active JPsA that have completed Study 20190530 or Study 20190529

Αξιολόγηση της μακροχρόνιας ασφάλειας της απρεμιλάστης σε ασθενείς ηλικίας 2 ετών και άνω με στοματικά έλκη που σχετίζονται με τη νόσο Αδαμαντιάδη-Behçet ή ηλικίας 5 ετών και άνω με ενεργή ΝΨΑ που έχουν ολοκληρώσει τη Δοκιμή 20190530 ή τη δοκιμή 20190529

E.2.2

Secondary objectives of the trial

Not applicable

Δεν Εφαρμόζεται

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject’s legally authorized representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
2. Subject must have completed week 52 (Apremilast Active Treatment Phase) of Study 20190529 (from France and Turkey sites only) or Study 20190530 where drug is not commercially available in their country.
3. Subject must have an age and sex specific body mass index (BMI) value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart (Appendix 11.7) for children and adolescents (CDC, 2000) at randomization.
4. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
5. Subject must have acceptable benefit/risk for continued treatment with apremilast.

1. Ο νόμιμος εκπρόσωπος του ασθενούς έχει παράσχει συναίνεση μετά από ενημέρωση όταν ο ασθενής δεν έχει τη νόμιμη ηλικία για παροχή συναίνεσης μετά από ενημέρωση και ο ασθενής έχει παράσχει έγγραφη συναίνεση με βάση τους τοπικούς κανονισμούς ή/και τις τοπικές κατευθυντήριες οδηγίες πριν από την έναρξη οποιασδήποτε δραστηριότητας/διαδικασίας της δοκιμής.
2. Οι ασθενείς θα πρέπει να έχουν ολοκληρώσει την επίσκεψη της εβδομάδας 52 (Φάση Δραστικής Θεραπείας με Απρεμιλάστη) της Δοκιμής 20190529 (από κέντρα της Γαλλίας και της Τουρκίας μόνο) ή της Δοκιμής 20190530, όπου το φάρμακο δεν κυκλοφορεί στην αγορά της χώρας τους.
3. Ο ασθενής θα πρέπει να έχει τιμή δείκτης μάζας σώματος (ΔΜΣ), με βάση την ηλικία και το φύλο του, όχι χαμηλότερη σε εύρος από το 5ο εκατοστημόριο του πίνακα ανάπτυξης που παρέχεται από το Κέντρο για τον Έλεγχο Νοσημάτων (CDC) των ΗΠΑ (Παράρτημα 11.7) για παιδιά και εφήβους (CDC, 2000) κατά την τυχαιοποίηση.
4. Ο ασθενής είναι πρόθυμος και ικανός να τηρήσει το χρονοδιάγραμμα των επισκέψεων της δοκιμής και τις υπόλοιπες απαιτήσεις του πρωτοκόλλου.
5. Ο ασθενής θα πρέπει να έχει αποδεκτό προφίλ οφέλους/ κινδύνου για συνέχιση της θεραπείας με απρεμιλάστη.

E.4

Principal exclusion criteria

1. Answer “Yes” to any question on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the week 52 visit on Study 20190529 (subjects from France and Turkey sites only) or Study 20190530.
2. Scheduled surgery or other interventions that would interrupt the subject’s participation in the study.
3. Female subjects of childbearing potential (for the purpose of this study, a female subject is considered of childbearing potential if she is 12 years old or older or has reached menarche, whichever occurred first) unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 30 days after the last dose of investigational product.
4. Female subjects planning to become pregnant while on study through 30 days after the last dose of investigational product.
5. Female subjects of childbearing potential with a positive pregnancy test assessed at week 0 by a highly sensitive urine or serum pregnancy test.
6. Subject has known sensitivity to any of the products to be administered during dosing.
7. Subject likely to not be available to complete all protocol-required study visits.

1. Απάντηση «Ναι» σε οποιαδήποτε ερώτηση της Κλίμακας Αξιολόγησης της Βαρύτητας της Αυτοκτονικότητας του Πανεπιστημίου Columbia (C-SSRS) στην επίσκεψη της εβδομάδας 52 της Δοκιμής 20190529 (ασθενείς από κέντρα της Γαλλίας και της Τουρκίας μόνο) ή της Δοκιμής 20190530.
2. Προγραμματισμένη χειρουργική επέμβαση ή άλλες παρεμβάσεις που θα διέκοπταν τη συμμετοχή του ασθενούς στη δοκιμή.
3. Κορίτσι με δυνατότητα τεκνοποίησης (για τον σκοπό αυτής της δοκιμής, ένα κορίτσι θεωρείται ότι έχει δυνατότητα τεκνοποίησης εάν είναι ηλικίας ≥ 12 ετών ή βρίσκεται μετά την εμμηναρχή, όποιο είναι προγενέστερο) που είναι απρόθυμο να χρησιμοποιεί μία από τις καθορισμένες από το πρωτόκολλο μεθόδους αντισύλληψης που αναφέρονται στο Παράρτημα 5 (Ενότητα 11.5) κατά τη διάρκεια της θεραπείας και για ένα επιπρόσθετο διάστημα 30 ημερών μετά την τελευταία δόση του υπό έρευνα προϊόντος.
4. Κορίτσι προγραμματίζει να μείνει έγκυος ενώ συμμετέχει στη δοκιμή και για έως και 30 ημέρες μετά την τελευταία δόση του υπό έρευνα προϊόντος.
5. Κορίτσι με δυνατότητα τεκνοποίησης και θετικό απότελεσμα σε δοκιμασία κύησης που πραγματοποιήθηκε την εβδόμαδα 0 μέσω μιας δοκιμασίας κύησης ούρων ή ορού υψηλής ευαισθησίας.
6. Ο ασθενής έχει γνωστή ευαισθησίας σε οποιοδήποτε από τα προϊόντα που πρόκειται να χορηγηθούν κατά τη διάρκειας της δοσολογίας.
7. Ο ασθενής είναι πιθανό να μην είναι διαθέσιμος για την ολοκλήρωση όλων των απαιτούμενων από το πρωτόκολλο επισκέψεων της δοκιμής.

E.5 End points

E.5.1

Primary end point(s)

- Adverse events: Type, frequency, severity, and relationship to apremilast
- Columbia-Suicide Severity rating Scale (C-SSRS)
- Tanner Staging
- Body weight, height, and body mass index (BMI)
- Vital signs and laboratory parameters

•Ανεπιθύμητα συμβάντα: Τύπος, συχνότητα, βαρύτητα και σχέση με την απρεμιλάστη.
•Κλίμακα Αξιολόγησης της Βαρύτητας της Αυτοκτονικότητας του Πανεπιστημίου Columbia (C-SSRS)
•Στάδιο κατά Tanner
•Σωματικό βάρος, ύψος και δείκτης μάζας σώματος (ΔΜΣ)
•Ζωτικά σημεία και εργαστηριακές παράμετροι

E.5.1.1

Timepoint(s) of evaluation of this end point

week 0, 26 , 52, 78, 104, 130 , 156 , 182 , 208 and 212

Εβδομάδα 0, 26, 52, 78, 104, 130, 156, 182, 208 και 212

E.5.2

Secondary end point(s)

Not applicable

Δεν Εφαρμόζεται

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

Δεν Εφαρμόζεται

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

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

Israel

France

Spain

Switzerland

Greece

Italy

Turkey

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

LVLS

Τελευταία Επίσκεψη Τελευταίου Ασθενούς

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

children aged 2-11 years old and adolescents aged 12-17 years old, accompanied by parents or carer

παιδιά ηλικίας 2-11 ετών και έφηβη ηλικίας 12-17 ετών, συνοδεύονται από γονείς ή φροντιστές

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

F.4.2.2

In the whole clinical trial

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)

Not applicable

Δεν Εφαρμόζεται

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

2023-04-04

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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