Clinical Trials Register

Summary
EudraCT Number:	2020-000851-11
Sponsor's Protocol Code Number:	W00118CR401
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:	2020-11-04
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

France - ANSM

A.2

EudraCT number

2020-000851-11

A.3

Full title of the trial

Frequency and Intensity of local reactions in patients treated with 4% 5-FU vs 4% 5-FU associated with an emollient cream: a randomised, controlled clinical trial

Fréquence et Intensité des réactions locales chez les patients traités avec du 5-FU à 4 % comparé au 5-FU à 4 % associé à une crème émolliente dans un essai clinique randomisé et contrôlé

A.3.1

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

Frequency and Intensity of local reactions in patients treated with 4% 5-FU vs 4% 5-FU associated with an emollient cream: a randomised, controlled clinical trial

A.3.2

Name or abbreviated title of the trial where available

TOLAK

A.4.1

Sponsor's protocol code number

W00118CR401

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	Pierre Fabre Dermatologie
B.1.3.4	Country	France
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	Pierre Fabre Dermatologie
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Katholisches Klinikum Bochum gGmbH
B.5.2	Functional name of contact point	National Coordination center
B.5.3	Address:
B.5.3.1	Street Address	Gudrunstraße 56
B.5.3.2	Town/ city	Bochum
B.5.3.3	Post code	44791
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49234509 6052

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	Tolak 40 mg/g Creme
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre Fabre Dermo-Kosmetik GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Cream
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	Fluorouracil
D.3.9.3	Other descriptive name	FLUOROURACIL
D.3.9.4	EV Substance Code	SUB07721MIG
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	40
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.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	Dexeryl
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre Fabre
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Dexeryl
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
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

Actinic keratosis with 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic.

Kératose actinique avec au moins 5 lésions cliniquement reconnaissables (palpables et / ou visibles à l'œil nu) du visage et / ou des oreilles et / ou du cuir chevelu. Les lésions doivent être cliniquement typiques non hypertrophiques et / ou non hyperkératosiques.

E.1.1.1

Medical condition in easily understood language

Actinic keratosis

Kératose actinique

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main study objective is to assess the frequency and the intensity of the local skin reactions at the end of the treatment course (or before in case of patient withdrawal).

L'objectif principal de l'étude est d'évaluer la fréquence et l'intensité des réactions cutanées locales à la fin du traitement (ou avant en cas de retrait du patient).

E.2.2

Secondary objectives of the trial

The other objectives are to evaluate the drop-outs due to AEs related to local skin reactions, the general safety and the clinical efficacy by the investigator.
Patients will evaluate the treatment satisfaction (acceptability), the treatment adherence and the health-related quality of life during the treatment.

Les autres objectifs sont d'évaluer les abandons dus aux EI liés aux réactions cutanées locales, la tolérance générale et l'efficacité clinique par l'investigateur.
Les patients évalueront la satisfaction au traitement (acceptabilité), l'observance du traitement et la qualité de vie liée pendant le traitement.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants are eligible only if all of the following criteria apply:
Age
1. Participant must be more than 18 years old inclusive, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2. Individuals with a clinical diagnosis of actinic keratosis (AK).
3. Individuals harboring 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The AK lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic.
4. Subject in good general condition and free of any disease state or condition which, in the investigator's opinion, could impair evaluation of actinic keratosis or could expose the subject to an unacceptable risk by study participation.
Sex
5. Male or female.
A Female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP), defined as postmenopausal (cessation of menses >12 months) or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, total hysterectomy).

Informed Consent
6. Capable of giving signed informed consent as described in Appendix 1: Regulatory, Ethical, and Study Oversight Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Ethical/Legal considerations
7. Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).

Les participants ne sont éligibles que si tous les critères suivants s'appliquent:
Âge
1. Le participant doit être âgé de plus de 18 ans inclus, au moment de la signature du consentement éclairé.
Type de participant et caractéristiques de la maladie
2. Les personnes avec un diagnostic clinique de kératose actinique (KA).
3. Les personnes présentant au moins 5 lésions AK cliniquement reconnaissables (palpables et / ou visibles à l'œil nu) du visage et / ou des oreilles et / ou du cuir chevelu. Les lésions AK doivent être cliniquement typiques non hypertrophiques et / ou non hyperkératosiques.
4. Sujet en bon état général et exempt de tout état pathologique ou condition qui, de l'avis de l'investigateur, pourrait nuire à l'évaluation de la kératose actinique ou exposer le sujet à un risque inacceptable en participant à l'étude.
Sexe
5. Homme ou femme.
Une participante est éligible à participer si elle n'est pas une femme en âge de procréer (WOCBP), définie comme ménopausée (arrêt des règles> 12 mois) ou chirurgicalement stérile (antécédents de ligature des trompes bilatérale, ovariectomie bilatérale, hystérectomie totale).

Consentement éclairé
6. Capable de donner un consentement éclairé signé comme décrit dans l'annexe 1: Considérations réglementaires, éthiques et de supervision de l'étude, qui comprend le respect des exigences et des restrictions énumérées dans le formulaire de consentement éclairé (ICF) et dans ce protocole.
Considérations éthiques / juridiques
7. Affilié à un système de sécurité sociale, ou est un bénéficiaire (si applicable dans la réglementation nationale).

E.4

Principal exclusion criteria

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. With AK lesions within treatment areas which are hyperkeratotic or which are clinically suspected to be squamous cell carcinoma (SCC).
2. With pre-existing local skin reactions with a total score ≥ 3.
3. History of hypersensitivity to the ingredients of Tolak® or Dexeryl®.
4. With a known allergy to peanut or soya.
5. Non postmenopausal or non surgically sterile woman considered as WOCBP, pregnant or breastfeading women.
Prior/Concomitant Therapy
6. Under systemic 5-fluorouracil or any systemic cancer treatment within eight weeks prior to the study.
7. Under any other topical AK treatments or therapies (e.g., Cryotherapy or Photodynamic therapy) in the treatment area(s) within eight weeks prior to starting the study.
8. Treated with systemic steroids, immunosuppressants or immunomodulators within four weeks prior to the study.
9. Under prescription retinoids or topical steroids in the treatment area(s) within four weeks prior to the study.
10. With known dihydropyrimidinedehydrogénase (DPD) deficiency or under treatment with brivudine, sorivudine or analogues within 4 weeks prior to starting the study.
11. Treated with glycolic acid products and alpha-hydroxy products in the treatment area(s) within four weeks prior to starting the study.
12. Treated with chemical peeling products in the treatment area(s) within eight weeks prior to starting the study.
Prior/Concurrent Clinical Study Experience
13. Is participating in another clinical trial
14. Has participated in another clinical trial within the last 30 days, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial
Other Exclusions
15. Is a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician,…)
16. Is in a position likely to represent a conflict of interest
17. Has forfeited his / her freedom by administrative or legal award or is under guardianship

Les participants sont exclus de l'étude si l'un des critères suivants s'applique:
Les conditions médicales
1. Avec des lésions AK dans les zones de traitement qui sont hyperkératosiques ou qui sont cliniquement suspectées d'être un carcinome épidermoïde (SCC).
2. Avec des réactions cutanées locales préexistantes avec un score total ≥ 3.
3. Antécédents d'hypersensibilité aux ingrédients de Tolak® ou Dexeryl®.
4. Avec une allergie connue à l'arachide ou au soja.
5. Femme non ménopausée ou non chirurgicalement stérile considérée comme WOCBP, femme enceinte ou allaitante.
Thérapie antérieure / concomitante
6. Sous 5-fluorouracile systémique ou tout autre traitement systémique contre le cancer dans les huit semaines précédant l'étude.
7. Dans le cadre de tout autre traitement ou thérapie topique d'AK (par exemple, cryothérapie ou thérapie photodynamique) dans la ou les zones de traitement dans les huit semaines précédant le début de l'étude.
8. Traités avec des stéroïdes systémiques, des immunosuppresseurs ou des immunomodulateurs dans les quatre semaines précédant l'étude.
9. Sous prescription de rétinoïdes ou de stéroïdes topiques dans la ou les zones de traitement dans les quatre semaines précédant l'étude.
10. Avec un déficit connu en dihydropyrimidinedehydrogénase (DPD) ou sous traitement par brivudine, sorivudine ou analogues dans les 4 semaines précédant le début de l'étude.
11. Traités avec des produits à base d'acide glycolique et des produits alpha-hydroxy dans la ou les zones de traitement dans les quatre semaines précédant le début de l'étude.
12. Traités avec des produits de peeling chimiques dans la ou les zones de traitement dans les huit semaines précédant le début de l'étude.
Expérience d'études cliniques antérieures / simultanées
13. Participe à un autre essai clinique
14. A participé à un autre essai clinique au cours des 30 derniers jours, a reçu un traitement avec des effets résiduels connus ou a fait l'objet d'une enquête susceptible d'interférer avec le présent essai clinique
Autres exclusions
15. Est-ce un membre de la famille de l'enquêteur ou de tout associé, collègue et employé participant à la conduite de l'étude (secrétaire, infirmière, technicien,…)
16. Est susceptible de représenter un conflit d'intérêts
17. A perdu sa liberté par décision administrative ou judiciaire ou est sous tutelle

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint in this trial is the Local Skin Reaction (LSR) total score

Le critère d'évaluation principal de cet essai est le score total de réaction cutanée locale (LSR)

E.5.1.1

Timepoint(s) of evaluation of this end point

at W4, or at an optional visit (LOCF) in case of major local reactions.

après 4 semaines, ou lors d'une visite facultative (LOCF) en cas de réactions locales majeures.

E.5.2

Secondary end point(s)

The secondary outcomes will be the following:
Tolerability:
• Local skin reactions: LSR total score at week 2 and Weekweek 8;
• LSR items alone at each visit (see below): presence/absence and intensity;
• Local reactions CTCAE grade 3 or 4.
Other safety evaluations:
• Other AEs reported by patients or noticed by investigator (see section 8.4 AE and SAE of the protocol);
• Drop outs due to AE related to local skin reactions (discontinuation rate);
• Use of rescue treatment (TCS).
AE will be collected during the whole study period from signature of informed consent up to week 8 (W8) or premature withdrawal. Any clinical findings obtained during the study, will be followed until the condition returns to normal or stabilized.
Patient reported outcomes:
• Subjective signs at each visit: prurit (0-3), stinging/burning (0-3), pain (0-4);
• Treatment satisfaction (acceptability): measured by TSQM-9 (treatment satisfaction questionnaire for medication) at W4 (end of treatment) or Patient Withdrawal (PW);
• Treatment adherence: assessed by direct questioning of the participant by the investigatorusing a self questionnaire at W4; and Optional Visit (OV; when applicable);
• Health-related quality of life: measured by AKQoL (actinic keratosis quality of life questionnaire, for Spain and Germany only) at baseline and W8 (4 weeks off-treatment and change from baseline).

Clinical response (efficacy): measured by
• Rates of patients with complete and partial clearance rates (cCR, pCR) at W8 (4 weeks off-treatment);
• Change and Percentage change in number of AK lesions from baseline to week 2 (W2), W4 and W8.
At each visit, the investigator will count of all visible and/or palpable actinic keratosis lesions in the treatment area(s).

Les résultats secondaires seront les suivants:
Tolérance:
• Réactions cutanées locales: score total LSR à la semaine 2 et à la semaine 8;
• Les items LSR seuls à chaque visite (voir ci-dessous): présence / absence et intensité;
• Réactions locales CTCAE grade 3 ou 4.
Autres évaluations de sécurité:
• Autres EI rapportés par les patients ou remarqués par l'investigateur (voir rubrique 8.4 EI et EIG du protocole);
• Abandons dus à des EI liés à des réactions cutanées locales (taux d'abandon);
• Utilisation d'un traitement de secours (TCS).
Les EI seront collectés pendant toute la durée de l'étude depuis la signature du consentement éclairé jusqu'à la semaine 8 (S8) ou le retrait prématuré. Tous les résultats cliniques obtenus au cours de l'étude seront suivis jusqu'à ce que la condition revienne à la normale ou se stabilise.
Résultats rapportés par les patients:
• Signes subjectifs à chaque visite: prurit (0-3), picotement / brûlure (0-3), douleur (0-4);
• Satisfaction au traitement (acceptabilité): mesurée par TSQM-9 (questionnaire de satisfaction au traitement pour les médicaments) à S4 (fin de traitement) ou au retrait du patient (PW);
• Observance du traitement: évaluée par un interrogatoire direct du participant par l'investigateur à l'aide d'un auto-questionnaire à S4; et visite facultative (VO, le cas échéant);
• Qualité de vie liée à la santé: mesurée par AKQoL (questionnaire sur la qualité de vie de la kératose actinique, pour l'Espagne et l'Allemagne uniquement) au départ et à S8 (4 semaines sans traitement et changement par rapport au départ).

Réponse clinique (efficacité): mesurée par
• Taux de patients avec des taux de clairance complète et partielle (cCR, pCR) à S8 (4 semaines sans traitement);
• Changement et changement en pourcentage du nombre de lésions AK entre le départ et la semaine 2 (S2), S4 et S8.
À chaque visite, l'investigateur comptera toutes les lésions de kératose actinique visibles et / ou palpables dans la ou les zones de traitement.

E.5.2.1

Timepoint(s) of evaluation of this end point

Detailed in E.5.2

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

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Group 1: patients treated with Tolak alone, Group 2: Patients treated with Tolak + Dexeryl

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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Last Visit Last Patient

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:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

140

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)

Since Tolak® and Dexeryl® are already approved and marketed as drug and medical device respectively, the investigator will have the possibility to prescribe Tolak® and Dexeryl® to his/her patient for a new course, after the end of the clinical study and the recommended time period between courses, if he/she believes it is the best course of action for the patient.

Puisque Tolak® et Dexeryl® sont déjà approuvés et commercialisés respectivement comme médicament et dispositif médical, l'investigateur aura la possibilité de prescrire Tolak® et Dexeryl® à son patient, après la fin de l'étude clinique et après la période recommandée entre deux traitements, s'il pense que c'est la meilleure ligne de conduite pour le patient.

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

2020-12-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-01-31

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