Clinical Trials Register

Summary
EudraCT Number:	2021-003314-39
Sponsor's Protocol Code Number:	78934804CRD2001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-09-19
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-003314-39

A.3

Full title of the trial

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease

Studio multicentrico di fase 2b, randomizzato, in doppio cieco, controllato con farmaco attivo e placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza della terapia combinata di induzione e mantenimento con guselkumab e golimumab in partecipanti affetti da malattia di Crohn attiva da moderata a grave

A.3.1

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

Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease

Efficacia e sicurezza della terapia combinata con guselkumab e golimumab in partecipanti affetti da malattia di Crohn attiva da moderata a grave

A.3.2

Name or abbreviated title of the trial where available

DUET-CD

A.4.1

Sponsor's protocol code number

78934804CRD2001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05242471

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	JANSSEN CILAG INTERNATIONAL NV
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	Janssen Research & Development
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	Parexel International LLC
B.5.2	Functional name of contact point	NA
B.5.3	Address:
B.5.3.1	Street Address	NA
B.5.3.2	Town/ city	NA
B.5.3.3	Post code	NA
B.5.3.4	Country	Ireland
B.5.6	E-mail	clinicaltrial.enquiries@parexel.com

D. IMP Identification
D.IMP: 1
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	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	Golimumab
D.3.2	Product code	[CNTO148]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Golimumab
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.4	EV Substance Code	SUB25638
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Anticorpo monoclonale
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	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	Guselkumab
D.3.2	Product code	[CNTO1959]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Guselkumab
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.4	EV Substance Code	SUB179789
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Anticorpo monoclonale
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	JNJ-78934804
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Guselkumab
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.4	EV Substance Code	SUB179789
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Golimumab
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.4	EV Substance Code	SUB25638
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Combinazione degli anticorpi monoclonali Guselkumab e Golimumab

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	Solution for injection/infusion in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderately to Severely Active Crohn's Disease

Morbo di Crohn da moderatamente a gravemente attivo

E.1.1.1

Medical condition in easily understood language

Inflammatory bowel disease (IBD)

Malattia infiammatoria intestinale (IBD)

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

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 evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)

Valutare l'efficacia di JNJ-78934804 alla settimana 48 rispetto a ogni monoterapia (guselkumab da solo e golimumab da solo)

E.2.2

Secondary objectives of the trial

1. To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcomes
2. To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo
3. To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo
4. To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy

1. Valutare l'efficacia di JNJ-78934804 rispetto ad ogni monoterapia attraverso una serie di risultati
2. Valutare l'efficacia di JNJ-78934804 alla settimana 24 rispetto al placebo
3. Valutare la sicurezza di JNJ-78934804 rispetto a placebo e monoterapia
4. Valutare la farmacocinetica (PK) e l'immunogenicità di JNJ-78934804 rispetto a ogni monoterapia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
•Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
•Demonstrated inadequate response, loss of response, or intolerance to at least one biologic
•If female and of childbearing potential, must meet the contraception and reproduction requirements

For an overview of all the inclusion criteria please refer to protocol section 5.1

•Diagnosi della malattia di Crohn almeno 3 mesi prima del basale
•Diagnosi confermata di CD da moderata a grave valutata dall'indice di attività del morbo di Crohn (CDAI), dalla frequenza delle feci (SF), dal punteggio del dolore addominale (AP) e dal punteggio endoscopico semplice per il morbo di Crohn (SES-CD)
•Dimostrata risposta inadeguata, perdita di risposta o intolleranza ad almeno un biologico
•Se di sesso femminile e in età fertile, devono soddisfare i requisiti di contraccezione e riproduzione

Per una descrizione di tutti i criteri di inclusione fare riferimento alla sezione 5.1 del protocollo

E.4

Principal exclusion criteria

•Complications of CD that may be anticipated to require surgery
•Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for
intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
•Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
•Has a draining (example, functioning) stoma or ostomy
•Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence
for greater than or equal to (>=)12 months before the first dose of study intervention
•Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer

For an overview of all the inclusion criteria please refer to protocol section 5.2

•Complicanze della malattia di Crohn che potrebbero richiedere un intervento chirurgico
•Presenza in corso o sospetta di ascesso. Gli ascessi cutanei e perianali recenti non sono motivo di esclusione se drenati e adeguatamente trattati almeno 3 settimane prima del basale o 8 settimane prima del basale per gli ascessi intra-addominali, a condizione che non vi sia alcuna necessità prevista di ulteriori interventi chirurgici
•Il soggetto è stato sottoposto a qualsiasi tipo di resezione intestinale nelle 24 settimane, o qualsiasi altro intervento chirurgico intra-addominale o altro intervento maggiore nelle 12 settimane
•Presenza di stoma drenante (ad esempio, funzionante) o stomia
•Attualmente presenta un tumore maligno o presenta un’anamnesi di tumore maligno nei 5 anni precedenti lo screening (ad eccezione di un tumore della pelle non melanoma che sia stato adeguatamente trattato senza evidenza di recidiva per un periodo superiore o uguale a (>=)12 mesi prima della prima dose di trattamento dello studio
•Presenza di una malattia infettiva anamnestica o in corso di natura cronica o ricorrente, tra cui, in modo non limitativo, infezioni sinopolmonari, bronchiectasia, infezioni ricorrenti renali/del tratto urinario (per esempio pielonefrite, cistite), ferita cutanea aperta, drenante o infetta oppure ulcera

Per una descrizione di tutti i criteri di inclusione fare riferimento alla sezione 5.2 del protocollo

E.5 End points

E.5.1

Primary end point(s)

Clinical remission and endoscopic response

Remissione clinica e risposta endoscopica

E.5.1.1

Timepoint(s) of evaluation of this end point

At Week 48

Alla settimana 48

E.5.2

Secondary end point(s)

1 Patient-Reported Outcomes (PRO)-2 remission and endoscopic remission
2 Clinical remission and endoscopic response of JNJ-78934804 at Week 24 compared with placebo
3 Frequency and type of adverse event (AEs), serious adverse events (SAEs)
4 Serum concentrations of guselkumab and golimumab over time
5 Incidence and titers of antibodies to guselkumab and golimumab
6 Incidence of neutralizing antibodies to guselkumab and golimumab

1 Remissione degli esiti riferiti dal paziente (PRO)-2 e remissione endoscopica
2 Remissione clinica e risposta endoscopica di JNJ-78934804 alla settimana 24 in confronto al placebo
3 Frequenza e tipo di eventi avversi (EA) ed eventi avversi seri (SAE)
4 Concentrazioni sieriche di guselkumab e golimumab nel tempo
5 Incidenza e titoli degli anticorpi anti-golimumab e anti guselkumab
6 Incidenza di anticorpi neutralizzanti anti-guselkumab e anti-golimumab

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - At Week 48
2 - At Week 24

1- Alla settimana 48
2 - Alla settimana 24

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

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Immunogenicità

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)

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

125

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

Argentina

Australia

Brazil

Canada

Chile

China

India

Israel

Japan

Jordan

Korea, Republic of

Malaysia

Mexico

New Zealand

Taiwan

United States

Austria

Estonia

Finland

France

Latvia

Lithuania

Poland

Sweden

Bulgaria

Netherlands

Spain

Switzerland

Czechia

Germany

Greece

Italy

Belgium

Bosnia and Herzegovina

Denmark

Georgia

Hungary

Norway

Portugal

Russian Federation

Slovakia

Slovenia

Turkey

Ukraine

United Kingdom

Serbia

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

The end of study is considered as the last scheduled study assessment shown in the SoA ( Schedule of activities) for the last participant or if a decision has been made by the sponsor not to pursue an indication in CD and appropriate follow-up has been completed.

La fine dello studio è considerata l'ultima valutazione dello studio schedulata mostrata nel SoA (Schedule of activities) per l'ultimo partecipante o se lo sponsor ha deciso di non perseguire un'indicazione in CD ed è stato completato un follow-up appropriato.

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:

715

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

130

F.4.2.2

In the whole clinical trial

715

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)

Participants who complete treatment and who are eligible for continued access program (post- study access or other open-label extension study under a different/separate protocol), all others participants will return to their normal treatment.

I partecipanti che hanno completato il trattamento e che sono elegibili per il programma di accesso continuo (accesso post studio o studio di estensione in aperto sotto un protocollo differente/separato), tutti gli altri partecipanti ritorneranno al loro trattamento normale

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

2022-12-13

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	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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