Clinical Trials Register

Summary
EudraCT Number:	2014-005024-10
Sponsor's Protocol Code Number:	I6F-MC-JJCB
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-05-27
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-005024-10

A.3

Full title of the trial

A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination with
Dexamethasone in T-ALL/T-LBL Patients

Studio di fase 1b e di fase 2 randomizzato, volto a valutare LY3039478 in combinazione con desametasone in pazienti T-ALL/T-LBL

A.3.1

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

A study in T-ALL/T-LBL Patients

Studio in pazienti T-ALL/T-LBL

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

I6F-MC-JJCB

A.5.4

Other Identifiers

Name:

Number:

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	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
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	Eli Lilly and Company
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	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	46285
B.5.3.4	Country	United States
B.5.4	Telephone number	0554257386
B.5.5	Fax number	0554257348
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.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.3.4	Pharmaceutical form	Capsule, hard
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	LY3039478
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB120814
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LY3039478
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB120814
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	50
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	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	Dexamethasone
D.3.4	Pharmaceutical form	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	DEXAMETHASONE
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	dexamethasone
D.3.9.4	EV Substance Code	SUB07017MIG
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	8
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic
lymphoma (T-LBL)

Leucemia linfoblastica acuta a cellule T (T-ALL) o linfoma linfoblastico a cellule T (T-LBL)

E.1.1.1

Medical condition in easily understood language

Leukemia and Lymphoma or blood cancer

Leucemia e linfoma o tumore del sangue

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10048683
E.1.2	Term	Advanced cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Phase1: to determine the recommended dose of LY3039478 in combination with dexamethasone in adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) (Part A) and pediatric patients (Part B)
Phase2: to determine if the overall remission rate (ORR) (CR plus CR with incomplete blood count recovery [CRi]) in adult patients with relapsed/refractory T-ALL/T-LBL treated with LY3039478 in combination with dexamethasone exceeds that of those patients treated with placebo in combination with dexamethasone

Fase 1: determinare la dose raccomandata di LY3039478 in combinazione con desametasone in pazienti adulti con leucemia linfoblastica acuta a cellule T (T-ALL) o linfoma linfoblastico a cellule T (T-LBL) recidivante/refrattario (Parte A) e in pazienti pediatrici (Parte B).
Fase 2: determinare se il tasso di remissione complessivo (ORR) (CR pi¿ CR con recupero incompleto della conta ematica [CRi]) in pazienti adulti con T-ALL/T-LBL recidivante/refrattario trattati con LY3039478 in combinazione con desametasone ¿ maggiore di quello dei pazienti trattati con placebo in combinazione con desametasone.

E.2.2

Secondary objectives of the trial

Phase1:Characterize the safety and toxicity profile of LY3039478 in combination with dexa as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0; Assess the PK parameters of LY in combination with dexa therapy; Document efficacy based on Cheson criteria for leukemia and modified response criteria for malignant lymphoma; Evaluate gene mutation status with efficacy. Phase2:Compare the ORR plus partial remission PR and PR alone for both arms; Assess the remission rate for patients receiving LY in combination with dexa after failure of placebo in combination with dexa; Assess DoR=CR and Cri and PR; Assess relapse-free survival, event-free survival, and overall survival; Compare the safety and toxicity profile of LY in combination with dexa to dexa and placebo as assessed by NCI CTCAE v 4.0; Assess the PK parameters of LY and dexa in combination therapy; Assess patient quality of life using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu);

Fase 1: caratterizzare il profilo di sicurezza e tossicit¿ di LY3039478 pi¿ desametasone sulla base dei CTCAE v. 4.0 dell¿NCI;valutare i parametri PK di LY in combinazione con la terapia a base di desametasone;documentare l¿efficacia sulla base dei criteri Cheson per la leucemia e dei criteri di risposta modificati per i linfomi maligni;valutare lo stato delle mutazioni geniche con l¿efficacia. Fase 2:confrontare l¿ORR pi¿ remissione parziale (PR) e la sola PR in entrambi i bracci;valutare: il tasso di remissione dei pz trattati con LY pi¿ desametasone dopo il fallimento del placebo pi¿ desametasone, la DoR=CR e CRi e PR, la sopravvivenza libera da recidiva, la sopravvivenza libera da eventi e la sopravvivenza globale;confrontare il profilo di sicurezza e tossicit¿ di LY pi¿ desametasone con quello di desametasone e placebo in base ai CTCAE v. 4.0 dell¿NCI;valutare i parametri PK di LY e desametasone in terapia di associazione;valutare la qualit¿ di vita dei pz con il quest FACT-Leu;

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must have T-ALL or T-LBL. T-ALL is defined =25% of blasts in the bone marrow and expression of at least 2 of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and/or CD8. If the only T cell markers present are CD4 and CD7, the leukemia cells must also lack the myeloid markers CD33 and/or CD13. Patients with initial refractory disease should have received at least 2 multi-agent chemotherapy induction regimens. Patients in first or second relapse must have been refractory to at least 1 multi-agent chemotherapy reinduction regimen. They must have had at least 60 days between prior hematopoietic stem cell transplant and first dose of study drug, have adequate performance status and organ function, be =16 years old for the adult cohort (Phase 1, Part A) and 2 to <16 years old for the pediatric cohort (Phase 1, Part B), and have a life expectancy of 2 months.

I pazienti devono avere T-ALL o T-LBL. T-ALL è definita da =25% di blasti nel midollo osseo ed espressione di almeno 2 dei seguenti antigeni di superficie: CD1a, CD2, CD3 (di superficie o citoplasmatico), CD4, CD5, CD7 e/o CD8. Se gli unici marcatori dei linfociti T presenti sono CD4 e CD7, le cellule leucemiche devono anche essere prive di marcatori mieloidi CD33 e/o CD13. I pazienti con malattia refrattaria iniziale devono aver ricevuto almeno due regimi polichemioterapici di induzione con più agenti. I pazienti in prima o seconda recidiva devono essere risultati refrattari ad almeno 1 regime polichemioterapico di reinduzione con più agenti. Devono essere trascorsi almeno 60 giorni tra il precedente trapianto di cellule staminali emopoietiche e la prima dose del farmaco sperimentale, i pazienti devono avere un performance status e una funzionalità d’organo adeguati, avere =16 anni per la coorte adulta (fase 1, Parte A) e 2-<16 anni per la coorte pediatrica (fase 1, Parte B) e avere un’aspettativa di vita di 2 mesi.

E.4

Principal exclusion criteria

Patients may be excluded if they are currently enrolled in another ongoing clinical trial with investigational
products, have recently discontinued (within less than 2 weeks) prior anticancer therapy, have a serious concomitant illness, have an uncontrolled or active infection <7 days prior to administration of study drug, have current or recurrent (within 3 months) gastrointestinal disease, have conditions requiring chronic systemic glucocorticoid use, have active graft versus host disease, have active leukemic involvement of the central nervous system, or have a second primary or prior malignancy that would affect the interpretation of study results.

I pazienti possono essere esclusi se sono attualmente arruolati in un altro studio clinico in corso su prodotti sperimentali, hanno interrotto di recente (da meno di 2 settimane) una precedente terapia antitumorale, sono affetti da una malattia concomitante grave, hanno un’infezione attiva o non controllata da <7 giorni prima della somministrazione del farmaco sperimentale, sono affetti da una malattia gastrointestinale all’esordio o recidivante (nei 3 mesi precedenti), presentano condizioni che richiedono l’utilizzo cronico di glucocorticoidi sistemici, hanno malattia da trapianto contro l’ospite attiva, presentano coinvolgimento leucemico attivo del sistema nervoso centrale o hanno una seconda neoplasia maligna secondaria o una neoplasia maligna pregressa che influenzerebbe l’interpretazione dei risultati dello studio.

E.5 End points

E.5.1

Primary end point(s)

Phase 1: Number of participants with dose limiting toxicities (DLTs) Phase 2: Overall Remission Rate

Fase 1: numero di partecipanti con tossicità dose-limitanti (DLT)
Fase 2: tasso di remissione complessivo

E.5.1.1

Timepoint(s) of evaluation of this end point

Phase 1: Baseline to disease progression or patient discontinuation Phase 2: Baseline to study completion

Fase 1: dal basale alla progressione della patologia o all’interruzione da parte del paziente
Fase 2: dal basale al termine dello studio

E.5.2

Secondary end point(s)

Phase1: 1)Number of participants with one or more drug related Adverse Events (AEs) or any Serious AEs 2)Pharmacokinetics: maximum concentration (Cmax) of LY3039478 in combination with Dexamethasone 3)Pharmacokinetics: area under the concentration curve (AUC) of LY3039478 in combination with Dexamethasone 4)Overall Remission Rate Phase2: 1)Overall Remission Rate plus Partial Remission Rate 2)Partial Remission Rate 3)Duration of Remission 4)Relapse Free Survival 5)Event free survival 6)Overall Survival 7)Number of participants with one or more drug related Adverse Events (AEs) or any Serious AEs 8)Pharmacokinetics: maximum concentration (Cmax) of LY3039478 in combination with Dexamethasone 9)Pharmacokinetics: area under the concentration curve (AUC) of LY3039478 in combination with Dexamethasone 10)FACT-Leu

Fase 1:
1) Numero di partecipanti con uno o pi¿ eventi avversi (EA) farmaco-correlati o qualsiasi EA grave
2) Farmacocinetica: concentrazione massima (Cmax) di LY3039478 in combinazione con desametasone
3) Farmacocinetica: area sotto la curva della concentrazione (AUC) di LY3039478 in combinazione con desametasone
4) Tasso di remissione complessivo
Fase 2:
1) Tasso di remissione complessivo pi¿ tasso di remissione parziale
2) Tasso di remissione parziale
3) Durata della remissione
4) Sopravvivenza libera da recidiva
5) Sopravvivenza libera da eventi
6) Sopravvivenza globale
7) Numero di partecipanti con uno o pi¿ eventi avversi (EA) farmaco-correlati o qualsiasi EA grave
8) Farmacocinetica: concentrazione massima (Cmax) di LY3039478 in combinazione con desametasone
9) Farmacocinetica: area sotto la curva della concentrazione (AUC) di LY3039478 in combinazione con desametasone
10) FACT-Leu

E.5.2.1

Timepoint(s) of evaluation of this end point

Phase 1: 1) Baseline to study completion 2) and 3) pre-dose to 6 hours post dose 4) baseline to study completion Phase 2: 1), 2) Baseline to study completion 3), 4) Date of remission to date of relapse or death 5) Date of study enrolment to date of relapse after remission, death or treatment failure 6)Date of study enrolment to date of death 7)Baseline to study completion 8), 9) pre-dose up to 8 hours post dose 10) baseline to end of cycle 1

Fase 1:
1) Dal basale al termine dello studio
2) e 3) Da prima della somministrazione a 6 ore dopo la somministrazione
4) Dal basale al termine dello studio
Fase 2:
1) e 2) Dal basale al termine dello studio
3) e 4) Dalla data di remissione alla data di recidiva o decesso
5) Dalla data di arruolamento nello studio alla data di recidiva dopo remissione, di decesso o di fallimento terapeutico
6) Dalla data di arruolamento nello studio alla data di decesso
7) Dal basale al termine dello studio
8) e 9) Da prima della somministrazione a 8 ore dopo la somministrazione
10) Dal basale al termine del ciclo 1

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

adaptive

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Fase 1 Aumento della dose - Fase II

Phase 1 Dose-escalation - Phase II

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

Australia

Israel

Taiwan

Turkey

United States

France

Germany

Italy

Netherlands

Sweden

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

Occurs after study completion and after the last patient has discontinued study treatment and completed continued access period follow-up (if applicable).

Si verifica dopo il completamento dello studio e dopo che l¿ultimo paziente ha interrotto il trattamento sperimentale e completato il follow-up del periodo di accesso esteso (se applicabile).

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

Yes

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)

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

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)

Investigators will perform any other standard procedures and tests needed to treat and evaluate patients; however, the choice and timing of the tests will be at the investigator¿s discretion

Gli Investigatori effettueranno qualsiasi altra procedura standard e test necessari per trattare e valutare i pazienti; comunque la scelta e la tempistica dei test sar¿ a discrezione dell'Investigatore

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

2016-09-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-10-11

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials