Clinical Trials Register

Summary
EudraCT Number:	2021-005487-22
Sponsor's Protocol Code Number:	A2A-005
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-06-23
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2021-005487-22

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy.

A.3.1

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

A clinical study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with metastatic nonsquamous non-small cell lung cancer who have progressed on immunotherapy.

A.4.1

Sponsor's protocol code number

A2A-005

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	iTeos Belgium SA
B.1.3.4	Country	Belgium
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	iTeos Belgium SA
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	iTeos Belgium SA
B.5.2	Functional name of contact point	Sally Ross
B.5.3	Address:
B.5.3.1	Street Address	rue des Frères Wright 29
B.5.3.2	Town/ city	Gosselies
B.5.3.3	Post code	6041
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3247471 05 85
B.5.6	E-mail	sally.ross@iteostherapeutics.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	Inupadenant 20 mg
D.3.2	Product code	EOS100850
D.3.4	Pharmaceutical form	Capsule
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	Inupadenant
D.3.9.1	CAS number	2411004-22-1
D.3.9.2	Current sponsor code	EOS100850
D.3.9.4	EV Substance Code	SUB218673
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	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	Inupadenant 40 mg
D.3.2	Product code	EOS100850
D.3.4	Pharmaceutical form	Capsule
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	Inupadenant
D.3.9.1	CAS number	2411004-22-1
D.3.9.2	Current sponsor code	EOS100850
D.3.9.4	EV Substance Code	SUB218673
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	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	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
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

Nonsquamous non-small cell lung cancer

E.1.1.1

Medical condition in easily understood language

Nonsquamous non-small cell lung cancer

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
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

Part 1 (Dose-Finding):
• To evaluate safety and tolerability of inupadenant in combination with carboplatin and pemetrexed
• To identify the inupadenant recommended Phase 2 dose (RP2D) to be used in combination with carboplatin and pemetrexed in Part 2 of the study

Part 2 (Randomized):
• To evaluate efficacy of inupadenant in combination with carboplatin and pemetrexed compared to the efficacy of the placebo in combination with carboplatin and pemetrexed

E.2.2

Secondary objectives of the trial

Part 1 Only:
• To evaluate efficacy of inupadenant in combination with carboplatin and pemetrexed
Part 2 Only:
• To evaluate safety and tolerability of inupadenant in combination with carboplatin and pemetrexed vs. placebo in combination with both drugs
• To evaluate additional measures of efficacy of inupadenant in combination with carboplatin and pemetrexed vs. placebo in combination with both drugs
• To assess the effect of inupadenant in combination with carboplatin and pemetrexed vs. placebo in combination with both drugs on time to onset and/or deterioration of lung cancer specific symptoms
Part 1 and Part 2:
• To evaluate pharmacokinetics of inupadenant and active metabolite EOS100612 in combination with carboplatin and pemetrexed

Please refer to Protocol Section 2 for other secondary objectives.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form prior to any study-specific evaluation.

2. Be ≥18 years of age at the time informed consent is signed.

3. Have histologically or cytologically confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable Stage III nonsquamous NSCLC that has relapsed or progressed.

4. Have measurable disease as defined by RECIST v1.1 criteria based on local assessment with at least 1 target lesion that has not been previously irradiated.

5. PD-L1 expression status must be available prior to the study entry. No prespecified PD-L1 expression status is necessary for inclusion (or enrollment).

6. Can provide a tumor sample from an existing biopsy taken within 2 years prior to entering trial or have at least one lesion that is accessible for a fresh biopsy where safe and feasible.

7. Have relapsed or progressed after prior anti-PD-1/PD-L1 therapy as follows:
- Have received only 1 anti-PD-1/PD-L1 agent in the metastatic setting, without concomitant chemotherapy, and have radiographic progression at least 12 weeks after the start of the anty-PD-1/PD-L1 therapy. One cycle of chemotherapy while awaiting molecular testing results prior to starting the anti-PD-1/PD-L1 agent is allowed. Immuno-oncology (IO)/IO combination therapy (standard or investigational) is allowed.

OR

- Have received anti-PD-1/PD-L1 therapy concurrently with and/or following chemoradiation in the Stage III unrespectable setting and have radiographic progression at least 6 months after the last doe of chemotherapy and at least 12 weeks after the start of the ant-PD-1/PD-L1 therapy. Immuno-oncology (IO)/IO combination therapy (standard or investigational) is allowed.
Note: Prior re-treatment with the same anti-PD-1/PD-L1 agent as well as prior SABR/SRS are allowed following progression on the anti-PD-1/PD-L1 regimen.

8. Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to treatment assignment:
Hematological:
- Absolute neutrophil count: ≥1,500 /mL
- Platelets: ≥100,000 /mL
- Hemoglobin: ≥9.5 g/dL or ≥5.9 mmol/L– 4 weeks without transfusions
Renal:
- Estimated glomerular filtration rate (Modification of Diet in Renal Disease method) (Levey, 1999) ≥ 60 mL/min
Hepatic
- Total bilirubin OR Direct bilirubin: Total bilirubin ≤1.5× institutional upper limit of normal (ULN). For a participant with Gilbert's syndrome, total bilirubin ≤3.0x institutional ULN is allowed if the increase is predominantly unconjugated bilirubin.
- Alanine transaminase (ALT) and aspartate transaminase (AST): ≤3× ULN; ≤5× ULN if liver metastases
Coagulation
- International Normalized Ratio (INR) or Prothrombin Time (PTT): ≤1.5× ULN unless the subject is receiving anticoagulant therapy.

9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

E.4

Principal exclusion criteria

1. Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
a. Participants with asymptomatic untreated CNS metastases are eligible provided that immediate CNS-specific treatment is unlikely in the Investigator's judgment.
b. Participants with previously treated CNS metastases are eligible provided the are neurologically stable and, if receiving corticosteroids for CNS metastases, are on a stable or decreasing corticosteroid dose for at least 2 weeks prior to the start of study treatment.
c. In participations with known CNS metastases, baseline CNS imaging must be obtained within 4 weeks prior to the start of study treatment.

2. Presence of active second malignancy, except for:
a. History of malignancy that has been successfully treated, with no evidence of active cancer for 1 year prior to enrollment
b. Surgically cured and/or low risk tumors e.g., early stage cervical or endometrial cancer, any cancer in situ, non-melanoma skin cancers.

3. Received systematic therapies for NSCLC, in the metastatic or Stage III unrespectable setting, other than 6 those described in inclusion criterion 7.

4. Have actionable mutation or genomic alteration in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK), or ROS1. Additionally, participants with known RET or NTRK rearrangement, BRAF V600E mutation, HER2 mutation, or MET exon 14 skipping mutation are excluded if targeted therapy is available as local standard of care (SOC).

5. Preexisting gastrointestinal disorders/conditions that would, in the opinion of the Investigator, interfere with ingestion or absorption of inupadenant.

6. History of or active (non-infectious) pneumonitis/ interstitial disease or lung fibrosis. (Note: Stage III participants with pneumonitis Grade 1 from the prior chemoradiation therapy that did not worsen on PD-1/PD-L1 therapy are allowed).

7. Have active or a history of autoimmune disease requiring systemic treatment in the last 6 months (e.g., with disease modifying agents, corticosteroids [>10mg daily prednisone equivalents], or immunosuppressive drugs) or persistent immune-mediated toxicity caused by checkpoint inhibitor therapy > Grade 1, with the exception of residual endocrinopathy being adequately treated, vitiligo, Type 1 diabetes mellitus (T1DM), or psoriasis not requiring systemic therapy. Replacement therapy (e.g., thyroxine, insulin, or corticosteroid replacement therapy for adrenal/pituitary insufficiency) is allowed.

8. Have known active or chronic hepatitis B or C infection unless treated with antiviral therapy for at least 4 weeks with no detectable viral load at the time of screening; known infection with human immunodeficiency virus (HIV) unless receiving antiretroviral therapy with well-controlled disease documented at the time of screening by a CD4+ T-cell count > 350 cell/μL, HIV RNA level of < 50 copies/mL or the lower-limit of detection at least 12 weeks prior to screening, and a stable treatment regimen for at least 4 weeks prior to enrollment that has been limited to the use of abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir. Participants are not required to be tested for the presence of such viruses prior to therapy on this protocol in the absence of a history of such infection or unless required by local health authorities.

9. History of life-threatening toxicity related to prior immune therapy or any toxicity resulting in permanent discontinuation from prior therapy after rechallenge.

10. Diagnosis of immunodeficiency or any condition requiring concurrent use of systemic immunosuppressants or corticosteroids (>10 mg daily prednisone equivalents). Premedication for chemotherapy or intravenous (IV) contrast is permitted; topical glucocorticoids are allowed.

11. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 7 days prior to first dose of study treatment.

12. Oncologic treatment including radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, targeted therapy, and/or experimental drugs administered ≤14 days (<28 days in case of checkpoint inhibitor therapy) prior to first dose of study treatment and/or ongoing adverse effects from such treatment > Grade 1, per NCI CTCAE version 5.0, with the exception for alopecia and Grade 2 peripheral neuropathy. (Note: Ongoing treatment with anti-cancer hormonal therapy for a previously treated cancer other than the disease under study is allowed).

13. Major surgical procedure ≤4 weeks prior to first dose of study treatment; participants with major surgical procedure >4 weeks prior to first dose of study treatment must be sufficiently recovered and stable before treatment administration.

Please refer to Protocol Section 3.5.2 for other exclusion criteria.

E.5 End points

E.5.1

Primary end point(s)

Part 1 (Dose-Finding):
• Incidence of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), AEs leading to dose-modifications or discontinuation, deaths, and clinically significant laboratory abnormalities.

Part 2 (Randomized):
• Progression-free survival (PFS), defined as time from randomization to the date of first documented radiological progression using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause.

E.5.1.1

Timepoint(s) of evaluation of this end point

AEs/SAEs/DLTs: Continuously from first intake of study drug up to 30 day follow-up visit or start of a new therapy, whichever date is first. Also at unscheduled visits.

Vital signs: Screening (Scr); Day (D) 1, D8 and D15 of Cycles 1 and 2; D1 for Cycle 3 onwards; End of Treatment (EoT); D30 after last dose then every 12 weeks until death, withdrawal of consent, lost to follow-up, or end of study

Hematology and serum/plasma chemistry: Scr; D1, D8 and D15 of Cycles 1 and 2; on D1 for Cycle 3 onwards; EoT; D30 after last dose

ECOG: Scr; D1 of all cycles; EoT; D30 after last dose

ECG: Scr; D1 of cycles 1-4; EoT

ECHO: Scr; EoT

Tumor assessment: every 6 weeks until 48 weeks and then then a frequency of every 12 weeks (more frequently, if clinically indicated).

E.5.2

Secondary end point(s)

Part 1 (Dose-Finding) Only:
•Overall response rate (ORR); duration of response; percent change in tumor size (CTS) from baseline; disease control rate (DCR), PFS, overall survival (OS).

Part 2 (Randomized) Only:
• Incidence and frequency of AEs, SAEs, and AEs leading to dose modifications or discontinuation, deaths, and clinically significant laboratory abnormalities.
• ORR; duration of response; percent CTS from baseline; DCR; disease control rate; OS.
• Time to definitive deterioration in global health status/quality of life (QoL), shortness of breath and pain per European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) questionnaire.
• Time to definitive 10-point deterioration symptom scores of pain, cough, and dyspnea per EORTC Lung (QLQ-LC13) questionnaire.
Part 1 and Part 2:
• Summary measures of pharmacokinetic (PK) parameters of inupadenant and active metabolite EOS100612 on Day1 and at steady state.

Please refer to Protocol Section 2 for other secondary endpoints.

E.5.2.1

Timepoint(s) of evaluation of this end point

AEs/SAEs and tumour assessment: as above.

Survival status: every 12 weeks until death, withdrawal of consent, lost to follow-up, or end of study.

QoL questionnaire: Days 1 of all Cycles; EoT; Day 30 after last dose.

PK: Days 1 and 8 of Cycles 1 and 2; Day 1 of cycles 3 and 4 and once anytime between cycle 5 and cycle 12; EoT.
Unscheduled PK sample should be collected at the onset of the first Grade ≥3 AE(s) that is at least possibly related to the study drug.

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

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

Determination of RP2D

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)

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

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

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

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

Switzerland

Canada

United Kingdom

United States

Belgium

Czechia

France

Germany

Italy

Poland

Spain

E.8.7

Trial has a data monitoring committee

Yes

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

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:

144

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

149

F.4.2.2

In the whole clinical trial

192

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

2022-09-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-29

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

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