Clinical Trials Register

Summary
EudraCT Number:	2021-000398-10
Sponsor's Protocol Code Number:	EFC16133
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2022-02-09
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2021-000398-10

A.3

Full title of the trial

A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative or positive, stage IIB-III breast cancer who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity

Az amcenesztrant (SAR439859) randomizált, multicentrikus, kettős vak, III. fázisú vizsgálata a tamoxifennel szemben olyan hormon receptor-pozitív, humán epidermális növekedési faktor receptor 2 negatív vagy pozitív, IIB-III. stádiumú emlőrákban szenvedő betegek kezelésére, akik a kezeléssel összefüggő toxicitás miatt megszakították az adjuváns aromatáz-gátló terápiát

A.3.1

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

Study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer, who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity

Az amcenesztrant (SAR439859) és a tamoxifen összehasonlítása olyan hormonreceptor pozitív (HR+) korai emlőrákban szenvedő betegeknél, akik a kezeléssel összefüggő toxicitás miatt abbahagyták az adjuváns aromatáz-gátló terápiát

A.3.2

Name or abbreviated title of the trial where available

AMEERA-6

A.4.1

Sponsor's protocol code number

EFC16133

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	Sanofi-aventis recherche & développement
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	Sanofi-aventis recherche & développement
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	Sanofi-Aventis Ltd.
B.5.2	Functional name of contact point	NA
B.5.3	Address:
B.5.3.1	Street Address	Váci út 133. 'E' épület 3. emelet
B.5.3.2	Town/ city	Budapest
B.5.3.3	Post code	1138
B.5.3.4	Country	Hungary
B.5.6	E-mail	kapcsolat@sanofi.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	Amcenestrant
D.3.2	Product code	SAR439859
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	Amcenestrant
D.3.9.2	Current sponsor code	SAR439859
D.3.9.3	Other descriptive name	SAR439859
D.3.9.4	EV Substance Code	SUB186740
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	200
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	Tamoxifen 20mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Pharmachemie B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Tamoxifen
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	Tamoxifen citrate
D.3.9.3	Other descriptive name	TAMOXIFEN CITRATE
D.3.9.4	EV Substance Code	SUB04672MIG
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.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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
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

Breast cancer

Emlődaganat

E.1.1.1

Medical condition in easily understood language

Breast cancer

Mellrák

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10006187
E.1.2	Term	Breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 determine whether amcenestrant once a day (QD) improves the invasive breast cancer-free survival (IBCFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment

Annak meghatározása, hogy a naponta egyszer (QD) alkalmazott amcenesztrant javítja-e az invazív emlőrákmentes túlélést (invasive breast cancer-free survival, IBCFS) a QD tamoxifennel összehasonlítva korai emlőrákban szenvedő betegeknél adjuváns kezelésként

E.2.2

Secondary objectives of the trial

•To determine whether amcenestrant once a day (QD) improves the invasive disease-free survival (IDFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment
•To evaluate the distant recurrence-free survival (DRFS) in both treatment arms
•To evaluate the locoregional recurrences-free survival (LRRFS) in both treatment arms
•To evaluate the overall survival (OS) in both treatment arms
•To evaluate the breast cancer-specific survival (BCSS) in both treatment arms
•To evaluate patient-reported overall treatment-related side effect bother, treatment-related symptoms, and quality of life in both treatment arms
•To evaluate safety in both treatment arms
•To characterize the pharmacokinetics (PK) of amcenestrant

• Annak meghatározása, hogy a naponta egyszer (QD) alkalmazott amcenesztrant javítja-e az invazív betegségmentes túlélést (invasive disease-free survival, IDFS) a QD tamoxifennel összehasonlítva korai emlőrákban szenvedő betegeknél adjuváns kezelésként
• A távoli kiújulásmentes túlélés (distant recurrence-free survival, DRFS) értékelése mindkét kezelési karban
• A helyi kiújulástól mentes túlélés (locoregional recurrences-free survival, LRRFS) értékelése mindkét kezelési karban
• A teljes túlélés (overall survival, OS) értékelése mindkét kezelési karon
• Az emlőrák-specifikus túlélés (breast cancer-specific survival, BCSS) értékelése mindkét kezelési karban
• A beteg által jelentett, a kezeléssel összefüggő általános mellékhatások, a kezeléssel összefüggő tünetek és az életminőség értékelése mindkét kezelési karon
• Biztonságosság értékelése mindkét kezelési karon
• Az amcenesztrant farmakokinetikájának (PK) jellemzése

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Adult participants with histologically confirmed diagnosis of adenocarcinoma of the breast with documentation of hormone receptor-positive status, irrespective of human epidermal growth factor receptor 2 (HER2) status
NOTE: Participants with HER2-positive breast cancer are eligible only if they have completed their adjuvant anti-HER2 treatment and chemotherapy.
-With Stage IIB or Stage III (invasive breast cancer) who have undergone breast surgery and adjuvant radiation (if indicated) for the current malignancy.
-Who have received prior aromatase inhibitors (AIs) (letrozole, anastrozole or exemestane or any sequence thereof) per the following: Adjuvant AI therapy was discontuined due to AI treatment-related toxicity;
Minimum of 6 months duration and maximum of 30 months duration (from initiation of the first AI if there was a switch between AIs) of AI therapy is required.
-Absence of locoregional and/or advanced/metastatic disease
-Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
-Capable of giving signed informed consent

- Azok a résztvevők, akiknél szövettanilag megerősítették az emlő adenokarcinómájának diagnózisát dokumentált hormon-pozitív státusz alapján, a HER2 státusztól függetlenül.
Megjegyzés: HER2 pozitív emlődaganatban szenvedő résztvevők akkor bevonhatóak, ha anti-HER2 adjuváns kezelésben és kemoterápiás kezelésben már részesültek.
- IIB vagy III. stádiumú (invazív emlőrákban szenvedő) résztvevők, akik a jelenlegi rosszindulatú daganatos megbetegedésüknek megfelelő (definitív) emlőműtéten és és adjuváns sugárterápián (ha indokolt) estek át.
- Azok a résztvevők, akik korábban aromatáz inhibitort (AI-t) (letrozolt, anasztrozolt vagy exemesztánt vagy ezek bármely sorozatát) kaptak az alábbiak szerint: - Az adjuváns AI-terápiát a kezeléssel összefüggő toxicitás miatt leállították; legalább 6 hónapos és maximum 30 hónapos AI-terápia szükséges (az első AI kezdetétől, ha az AI-terápiák között váltás történt).
- Nem áll fenn lokoregionális és/vagy előrehaladott/áttétes betegség.
- Keleti Kooperatív Onkológiai Csoport (ECOG) teljesítménystátusz (PS) 0-1.
- Képes a tájékoztatás utáni beleegyezés aláírására.

E.4

Principal exclusion criteria

-Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant and/or tamoxifen. Participants unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance to oral treatment. Active inflammatory bowel disease or chronic diarrhea, active hepatitis A/B/C, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures
-History of prior breast cancer for which they received an AI
-Any other solid tumor or lymphoma diagnosis is not allowed except if the participant has been free from disease for ≥5 years
-Pregnant or nursing women, or women of child-bearing potential without a negative pregnancy test prior to randomization
-Participants with unrecovered acute toxic effects of prior AI therapy or surgical procedures
-Uncontrolled intercurrent illness, including psychiatric conditions that would limit compliance with study requirements
-Treatment with any selective estrogen receptor degrader (SERD), tamoxifen or toremifene are not allowed as prior adjuvant therapy but could have been used as neoadjuvant therapy for a total duration of 3 months. Participants who were treated with a SERD, tamoxifen or toremifene in the neoadjuvant setting and who experienced disease progression are not allowed. Prior treatment with raloxifene or tamoxifen for bone health, risk reduction, or a prior breast cancer is allowed provided this was discontinued at least 3 years before diagnosis of current breast cancer
- Ongoing treatment with HER2-directed therapy. Appropriate wash out between the last dose of HER2 directed therapy and randomization should be at least 4 weeks

E.5 End points

E.5.1

Primary end point(s)

1) Invasive breast cancer-free survival (IBCFS)

1) Invazív emlőrákmentes túlélés (invasive breast cancer-free survival, IBCFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

1) From randomization up to approximately 10 years

1) Randomizálástól számítva megközelítőleg 10 évig

E.5.2

Secondary end point(s)

1)Invasive disease-free survival (IDFS)
2)Distant recurrence-free survival (DRFS)
3)Locoregional recurrences-free survival (LRRFS)
4)Overall survival (OS)
5)Breast cancer-specific survival (BCSS)
6)Patient-reported overall treatment-related side effect bother as measured by the Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5)
7)Patient-reported treatment-related symptoms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Breast cancer module (EORTC QLQ-B23) systemic therapy side effects scale
8)Patient-reported quality of life as measured by the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) global health status/quality of life (GHQ) scale
9)Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
10)PK parameter: Plasma concentration of Amcenestrant

1) Invazív betegségmentes túlélés (invasive disease-free survival, IDFS)
2) A távoli kiújulásmentes túlélés (distant recurrence-free survival, DRFS)
3) A helyi kiújulástól mentes túlélés (locoregional recurrences-free survival, LRRFS)
4) A teljes túlélés (overall survival, OS)
5) Az emlőrák-specifikus túlélés (breast cancer-specific survival, BCSS)
6) A beteg által jelentett, a kezeléssel összefüggő általános mellékhatások, a kezeléssel összefüggő tünetek és az életminőség értékelése (FACT-GP5)
7) A beteg által jelentett, szisztémás terápiával összefüggő mellékhatások meghatározása az EORTC Életminőségi kérdőív emlőrák modul (EORTC-QLQ-BR23) 'szisztémás terápia mellékhatásai' skálával mérve.
8) A beteg által jelentett életminőség a globális egészségi állapotnak/életminőségnek a meghatározására szolgáló EORTC alapvető életminőség kérdőív (EORTC QLQ-C30) globális egészségi állapot/életminőség (GHQ) skálájával mérve.
9) Betegek száma, akiknél kezeléssel összefüggő nemkívánatos események (TEAE-k) és súlyos nemkívánatos események (SAE-k), jelentkeztek.
10) Farmakokinetikai (PK) paraméterek: amcenesztrant plazma koncentrációja

E.5.2.1

Timepoint(s) of evaluation of this end point

1/2/3/4/5)From randomization up to approximately 10 years
6)From baseline up to 2 years after the end of treatment (up to approximately 7 years)
7)From baseline up to 2 years after the end of treatment (up to approximately 7 years)
8)From baseline up to 2 years after the end of treatment (up to approximately 7 years)
9)Up to 30 days after the end of treatment, approximately 5 years
10)Pre-administration day 1 of cycles 2, 7, 13 and 25 (each cycle is 28 days)

1/2/3/4/5) Randomizálástól számítva megközelítőleg 10 évig
6) Szűréstől a kezelés végétől számított 2 évig (megközelítőleg 7 évig)
7) Szűréstől a kezelés végétől számított 2 évig (megközelítőleg 7 évig)
8) Szűréstől a kezelés végétől számított 2 évig (megközelítőleg 7 évig)
9) A kezelés végétől számított 30 napig, megközelítőleg 5 évig
10) 1 nappal a 2., 7., 13. és 25. ciklus kezdő kezelését megelőzően (minden ciklus 28 napos)

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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

140

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

Argentina

Australia

Brazil

Canada

Chile

China

India

Japan

Korea, Republic of

Mexico

New Zealand

Taiwan

United States

Austria

Estonia

France

Sweden

Spain

Switzerland

Germany

Greece

Italy

Belgium

Denmark

Georgia

Hungary

Ireland

Portugal

Russian Federation

Turkey

Ukraine

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

Utolsó beteg utolsó vizit

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:

3970

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

700

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

1072

F.4.2.2

In the whole clinical trial

4670

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)

None

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

2022-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-03

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-10-13

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