Clinical Trials Register

Summary
EudraCT Number:	2020-003760-11
Sponsor's Protocol Code Number:	1346-0011
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:	2021-06-08
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-003760-11

A.3

Full title of the trial

phase III randomized, double-blind, placebo-controlled parallel group
trial to examine the efficacy and safety of BI 425809 once daily over 26
week treatment period in patients with schizophrenia (CONNEX-1)

Studio di fase III, randomizzato, in doppio cieco, controllato con placebo e a gruppi paralleli volto a esaminare l’efficacia e la sicurezza di BI 425809 una volta al giorno nel corso di un periodo di trattamento di 26 settimane in pazienti con schizofrenia (CONNEX-1)

A.3.1

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

Clinical trial of BI 425809 effect on cognition and functional capacity in
schizophrenia.

Studio clinico sull’effetto prodotto da BI 425809 sulla funzione cognitiva e sulla capacità funzionale nella schizofrenia

A.3.2

Name or abbreviated title of the trial where available

BI 425809 Pivotal efficacy study 1

A.4.1

Sponsor's protocol code number

1346-0011

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	BOEHRINGER-INGELHEIM ITALIA S.P.A.
B.1.3.4	Country	Italy
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	Boehringer Ingelheim Italia S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmbH &Co KG
B.5.2	Functional name of contact point	CT Disclosure & Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Birkendorfer Str. 65
B.5.3.2	Town/ city	Biberach
B.5.3.3	Post code	88397
B.5.3.4	Country	Germany
B.5.4	Telephone number	+498002430127
B.5.5	Fax number	+498008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	-
D.3.2	Product code	[BI 425809]
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.3.9.2	Current sponsor code	BI 425809
D.3.9.4	EV Substance Code	SUB130377
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	10
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	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	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	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

schizophrenia

schizofrenia

E.1.1.1

Medical condition in easily understood language

schizophrenia

schizofrenia

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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	10039626
E.1.2	Term	Schizophrenia
E.1.2	System Organ Class	10037175 - Psychiatric 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

The primary objective of this phase III pivotal trial in CIAS is to assess
the efficacy in improving cognitive impairment using MCCB in patients
with schizophrenia treated for 26 weeks with BI 425809 as compared
with placebo.

l’obiettivo primario consiste nel valutare l’efficacia in termini di miglioramento della compromissione cognitiva in base alla MATRICS Consensus Cognitive Battery (MCCB) in pazienti con schizofrenia trattati per 26 settimane con BI 425809 10 mg rispetto al placebo.

E.2.2

Secondary objectives of the trial

The key secondary objective is to assess the efficacy in daily functioning
of 26-week treatment with BI 425809 as compared with placebo in
terms of Schizophrenia Cognition Rating Scale (SCoRS) and Virtual
Reality Functional Capacity Assessment Tool (VRFCAT).
The secondary objectives are to assess the efficacy in improving
reasoning and problem solving and patients' experience of cognitive
impairment associated with their disease.

Il principale obiettivo secondario consiste nel valutare l’efficacia in termini di svolgimento delle attività quotidiane in base alla Schizophrenia Cognition Rating Scale (SCoRS) e al Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in pazienti con schizofrenia trattati per 26 settimane con BI 425809 10 mg rispetto al placebo. Gli altri obiettivi secondari consistono nel valutare l’efficacia in termini di miglioramento del ragionamento e del problem solving, nonché dell’esperienza dei pazienti rispetto alla compromissione cognitiva associata alla malattia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients must be capable of providing signed and dated written
informed consent by date of Visit 1 in accordance with ICH Harmonized
Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local
legislation prior to the admission to the trial.
2. Male or female patients who are 18-50 years (inclusive) of age at time
of consent.
3. Diagnosis of schizophrenia utilizing DSM-5 with the following clinical
features:
-- Outpatient, clinically stable and in the residual (non-acute) phase of
their illness.
-- No hospitalization or increase in level of psychiatric care due to
worsening of schizophrenia within 12 weeks prior to randomization.
-- PANSS score: items P1, P3-P6 <= 5 and item P2 and P7 <= 4 at Visit 1,
and confirmed at Visit 2.
4. Patients should have functional impairment in day-to-day activities
such as difficulties following conversation or expressing themselves,
difficulties to stay focused, difficulties to remember instructions, what to
say or how to get to places, per investigator judgement.
5. Patients maintained on current antipsychotic treatment (minimum 1
and maximum 2 antipsychotics, but clozapine is not allowed) for at least
12 weeks and on current dose for at least 35 days prior to
randomization.
-- Doses should be within the recommended dose range listed in the
approved product labelling of the country where the study is being
conducted.
-- Switch from 1-month to 3-monthinjectable formulation of same
antipsychotic during the 12 weeks prior to randomization is allowed, but
not with in last 35 days prior to randomization.
-- Note: If the total dose is stable, different dosage forms of the same
antipsychotic treatment will be considered as one antipsychotic.
6. Patients with any other concomitant psychoactive medications (except
for anticholinergics) need to be maintained on same drug for at least 12
weeks and on current dose/ regimen for at least 35 days prior to
randomization.
-- Maximum daily benzodiazepine load of up to 1 mg lorazepamequivalent
and
hypnotic load up to 0.25 mg brotizolam-equivalent as needed (pro re
nata, prn). Table of relevant medications and their equivalencies will be
provided as a part of ISF
-- For any other psychoactive medications, doses should be within the
recommended dose range listed in the approved product labelling of the
country where the study is being conducted.
Further criteria apply.

1. Prima dell’ammissione allo studio, i pazienti dovranno essere in grado di rilasciare il consenso informato scritto, firmato e datato, entro la data della Visita 1 ai sensi della ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) e della legislazione locale.

2. Pazienti di sesso maschile o femminile di età compresa tra 18 e 50 anni al momento del consenso.

3. Diagnosi di schizofrenia in base al Diagnostic and Statistical Manual of Mental Disorders, quinta edizione (DSM-5), con le seguenti caratteristiche cliniche:

• Paziente gestito in regime ambulatoriale clinicamente stabile e nella fase residua (non acuta) della malattia.
• Nessun ricovero in ospedale o aumento del livello delle cure psichiatriche dovuto a un peggioramento della schizofrenia nelle 12 settimane precedenti la randomizzazione.
• Punteggio nella Positive and Negative Symptoms Scale (PANSS): item P1, P3-P6 >= 5 e item P2 e P7 >= 4 alla Visita 1, confermati alla Visita 2.

4. I pazienti dovranno presentare compromissione funzionale nelle attività quotidiane, per esempio difficoltà a seguire una conversazione o a esprimersi, difficoltà a mantenere la concentrazione, difficoltà a ricordare le istruzioni, cosa dire o come raggiungere determinati luoghi, secondo il giudizio dello sperimentatore.

5. Pazienti sottoposti al trattamento antipsicotico (almeno 1 e massimo 2 antipsicotici; la clozapina non è ammessa) attuale per almeno 12 settimane e alla dose corrente per almeno 35 giorni prima della randomizzazione.
o Le dosi dovranno rientrare nel range di dose raccomandato riportato nelle indicazioni prescrittive approvate del prodotto relative al paese in cui viene condotto lo studio.

Nota: se la dose totale è stabile, diverse forme farmaceutiche dello stesso trattamento antipsicotico verranno considerate come un unico antipsicotico.

6. I pazienti in trattamento con altri farmaci psicoattivi concomitanti (ad esclusione degli anticolinergici) dovranno proseguire la terapia con il medesimo farmaco per almeno 12 settimane e alla dose/regime corrente per almeno 35 giorni prima della randomizzazione.
o Carico giornaliero massimo di benzodiazepine fino a una dose equivalente a 1 mg di lorazepam e carico di ipnotici fino a una dose equivalente a 0,25 mg di brotizolam secondo necessità (pro re nata [PRN]). La tabella dei farmaci pertinenti e delle relative equivalenze verrà fornita nell’Investigator Site File (ISF).
o Per quanto riguarda altri farmaci psicoattivi, le dosi dovranno rientrare nel range di dose raccomandato riportato nelle indicazioni prescrittive approvate del prodotto relative al paese in cui viene condotto lo studio.

7. Le donne in età fertile (WOCBP) dovranno essere disposte a, e in grado di, utilizzare metodi contraccettivi altamente efficaci ai sensi delle linee guida Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 [R2]) che, quando usati con costanza e correttamente, siano associati a un basso tasso di insuccesso (inferiore all’1% all’anno). Un elenco dei metodi contraccettivi che soddisfano tali criteri è fornito nel paragrafo 4.2.2.3. Tali metodi dovranno essere usati per l’intera durata della sperimentazione e per un periodo di almeno 35 giorni dopo l’ultima assunzione del farmaco in studio. La paziente dovrà inoltre acconsentire a sottoporsi a test di gravidanza periodici durante la partecipazione alla ricerca.

Altri criteri sono applicati (vedere la sinossi in italiano)

E.4

Principal exclusion criteria

1. Participant with current DSM-5 diagnosis other than Schizophrenia,
including but not limited to bipolar, schizoaffective, major depressive
disorder etc. M.I.N.I. for Psychotic disorders should be used for
guidance.
2. Cognitive impairment due to developmental, neurological (e.g.,
epilepsy, stroke) or other disorders including head trauma, or patients
with dementia.
3. Severe movement disorders
-- Leading to cognitive impairment (e.g. Parkinson dementia), or
-- Interfering with the efficacy assessments, or
-- Due to antipsychotic treatment that cannot be controlled with low
dose anticholinergic treatment (equal to maximum 1 mg benztropine
twice daily). Table of relevant medications and their equivalencies will
be provided as a part of ISF
4. Any suicidal behavior in the past 1-year prior to screening and during
the screening period.
5. Suicidal ideation of type 5 in the C-SSRS (i.e. active suicidal thought
with plan and intent)
in the past 3 months prior to screening and up to and including Visit 2.
-- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active
suicidal thought with intent but without specific plan), within 3 months
prior to screening and up to and including Visit 2, can be randomized in
the study, if assessed and documented by a licensed mental health
professional that there is no immediate risk of suicide.
6. History of moderate or severe substance use disorder (other than
caffeine and nicotine), as defined in DSM-5 within the last 12 months
prior to informed consent.
7. Positive urine drug screen at Visit 1 based on central lab test. For a
list of drugs assessed in the urine drug screen
8. Patients who were treated with any of the following within 6 months
prior to randomization:
-- Clozapine
-- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
-- Ketamine
-- Electroconvulsive therapy (ECT) or Modified ECT
Further criteria apply.

1. Partecipante con attuale diagnosi diversa dalla schizofrenia in base al DSM-5, tra cui, a titolo esemplificativo, disturbo bipolare, schizoaffettivo, depressivo maggiore, ecc. Per i disturbi psicotici dovrà essere usata, come orientamento, la Mini-International Neuropsychiatric Interview (M.I.N.I.).

2. Compromissione cognitiva dovuta a disturbi dello sviluppo, neurologici (per es. epilessia, ictus) o di altra natura, tra cui trauma cranico, o pazienti con demenza.

3. Disturbi severi del movimento
o Comportanti compromissione cognitiva (per es. demenza associata al Parkinson) o
o Che interferiscono con le valutazioni di efficacia o
o Dovuti al trattamento antipsicotico non controllabili con una terapia anticolinergica a basse dosi (equivalenti a un massimo di 1 mg di benztropina due volte al giorno). La tabella dei farmaci pertinenti e le relative equivalenze verrà fornita nell’ISF.

4. Qualsiasi comportamento suicidario nell’ultimo anno precedente lo screening e durante il periodo di screening.

5. Ideazione suicidaria di tipo 5 in base alla Columbia-Suicide Severity Rating Scale (C-SSRS) (ossia pensiero suicidario attivo con pianificazione e intento) negli ultimi 3 mesi precedenti lo screening e fino alla Visita 2 compresa.
• I pazienti con ideazione suicidaria di tipo 4 in base alla C-SSRS (ossia pensiero suicidario attivo con intento ma senza pianificazione specifica) nei 3 mesi precedenti lo screening e fino alla Visita 2 compresa potranno essere randomizzati nello studio, purché venga valutato e documentato da un professionista della salute mentale abilitato che non sussiste alcun rischio immediato di suicidio.

6. Storia di disturbo da uso di sostanze (diverse da caffeina e nicotina) moderato o severo secondo quanto definito nel DSM-5 negli ultimi 12 mesi precedenti il consenso informato.

7. Esame tossicologico delle urine positivo alla Visita 1 in base al test effettuato dal laboratorio centrale. Per un elenco dei farmaci valutati nell’esame tossicologico delle urine, vedere la Tabella 5.2.3:1.

8. Pazienti trattati con una qualsiasi delle seguenti sostanze nei 6 mesi precedenti la randomizzazione:
o Clozapina
o Stimolanti (per es. metilfenidato, destroamfetamina, modafinil)
o Ketamina
o Terapia elettroconvulsivante (TEC) o TEC modificata.

9. Partecipazione a uno studio su un farmaco psicoattivo sperimentale (di settore/accademico) negli ultimi 6 mesi, e nei 30 giorni o nelle 5 emivite (per gli studi su farmaci non psicoattivi), precedenti la randomizzazione.

10. Precedente partecipazione a uno studio su BI 425809.

Altri criteri sono applicati (vedere la sinossi in italiano)

E.5 End points

E.5.1

Primary end point(s)

1) Change from baseline in overall composite T-score of the MCCB after
26 weeks of treatment.

1) L'endpoint primario di efficacia è la valutazione della cognizione:
Variazione rispetto al basale del T-score composito complessivo dell'MCCB dopo 26 settimane di trattamento.

E.5.1.1

Timepoint(s) of evaluation of this end point

1) week 26

1) settimana 26

E.5.2

Secondary end point(s)

1) Key secondary endpoint: Change from baseline in the SCoRS
interviewer total score after 26 weeks of treatment
2) Keay secondary endpoint: Change from baseline to Week 26 in the
adjusted total time in the VRFCAT
3) Change from baseline to Week 26 in the T-score of the number of
correct responses on Tower of London.
4) Change from screening visit 1a to Week24 in Patient Reported
Experience of Cognitive Impairment in Schizophrenia (PRECIS) total
score

1)Variazione rispetto al basale nel punteggio totale SCoRS dell'intervistatore dopo 26 settimane di trattamento.
2)Cambiamento dal basale alla Settimana 26 del tempo totale corretto nel VRFCAT.
3)Modifica dal basale alla settimana 26 del punteggio T del numero di risposte corrette nella Torre di Londra.
4)Variazione dalla visita di screening 1a alla settimana 24 nel punteggio totale di deterioramento cognitivo nella schizofrenia (PRECIS) riportato dal paziente.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 26
2) week 26
3) week 26
4) week 24

1) settimana 26
2) settimana 26
3) settimana 26
4) 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

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)

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

Brazil

China

Colombia

Japan

Mexico

Russian Federation

United States

Germany

Greece

Italy

Norway

Poland

Sweden

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:

586

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

176

F.4.2.2

In the whole clinical trial

586

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)

Roll-over to open label extension trial for all patients who complete 26
weeks of treatment will be offered. For all patients, post trial treatment
will be according to standard of care.

Passaggio allo studio di estensione in aperto per tutti i pazienti che abbiano completato 26
settimane di trattamento.
Per tutti i pazienti, il trattamento post-sperimentazione
sarà conforme allo standard di cura.

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

2021-06-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-20

P. End of Trial
P.	End of Trial Status	Ongoing

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