Clinical Trials Register

Summary
EudraCT Number:	2021-003304-41
Sponsor's Protocol Code Number:	1397-0012
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:	2022-01-13
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

2021-003304-41

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled, parallel group, dosefinding
study evaluating efficacy, safety and tolerability of BI 1291583 qd
over at least 24 weeks in patients with bronchiectasis

Studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli e di individuazione della dose volto a valutare l’efficacia, la sicurezza e la tollerabilità di BI 1291583 qd nell’arco di almeno 24 settimane in pazienti con bronchiectasia

A.3.1

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

A study to test whether different doses of BI 1291583 help people with
bronchiectasis

Studio per valutare se differenti dosi di BI 1291583 siano d’aiuto a persone con bronchiectasia

A.3.2

Name or abbreviated title of the trial where available

CatC inhibitor Phase II in bronchiectasis

A.4.1

Sponsor's protocol code number

1397-0012

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	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	00498002430127
B.5.5	Fax number	00498008217119
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 1291583]
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.3.9.2	Current sponsor code	BI 1291583
D.3.9.4	EV Substance Code	SUB189070
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	5
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.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	-
D.3.2	Product code	[BI 1291583]
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.3.9.2	Current sponsor code	BI 1291583
D.3.9.4	EV Substance Code	SUB189070
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2500
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.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	-
D.3.2	Product code	[BI 1291583]
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.3.9.2	Current sponsor code	BI 1291583
D.3.9.4	EV Substance Code	SUB189070
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	1
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
D.8 Placebo: 2
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
D.8 Placebo: 3
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

bronchiectasis

bronchiectasia

E.1.1.1

Medical condition in easily understood language

bronchiectasis

bronchiectasia

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10006445
E.1.2	Term	Bronchiectasis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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 the trial is to assess a non-flat dose-response curve and to evaluate the dose-response relationship for 3 oral dose
regimens of BI 1291583 versus placebo, on the primary endpoint, time to first pulmonary exacerbation up to 48 weeks.

L’obiettivo primario consiste nel dimostrare una curva dose-risposta non piatta e nel valutare la correlazione dose-risposta di 3 regimi di somministrazione orale di BI 1291583 rispetto al placebo in termini di endpoint primario, ossia il tempo alla prima esacerbazione polmonare fino alla settimana 48.

E.2.2

Secondary objectives of the trial

The secondary objective is to assess superiority of BI 1291583 5 mg
versus placebo on the primary endpoint, the time to first pulmonary
exacerbation up to week 48, as well as on the secondary endpoint, the
rate of pulmonary exacerbations up to week 48.

L'obiettivo secondario è valutare la superiorità di BI 1291583 5 mg
rispetto al placebo sull'endpoint primario, il tempo al primo polmone
esacerbazione fino alla settimana 48, nonché sull'endpoint secondario, il
tasso di esacerbazioni polmonari fino alla settimana 48.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female (not of childbearing potential) patients
- Age of patients when signing the informed consent =18 and =85 years.
- Clinical history consistent with bronchiectasis (cough, chronic sputum
production and/or recurrent respiratory infections) and investigator
confirmed diagnosis of bronchiectasis by computed tomography (CT)
scan.
- History of pulmonary exacerbations requiring antibiotic treatment. In
the 12 months before Visit 1, patients must have had either:
-- at least 2 exacerbations, or
-- at least 1 exacerbation and a SGRQ Symptoms score of >40 at
screening visit 1.
For patients on stable oral or inhaled antibiotics as chronic treatment for
bronchiectasis, at least one exacerbation must have occurred since
initiation of stable antibiotics.
- Current sputum producers with a history of chronic expectoration

1. Pazienti di sesso maschile o femminile. Le donne in età fertile (WOCBP) (1) che risponderanno ai requisiti di contraccezione potranno essere incluse non appena saranno soddisfatti i criteri regolatori (vedere paragrafo 4.2.2.4). All’inizio dello studio, ciò è considerato possibile solo per le WOCBP in USA, Canada, Messico e Turchia.
Sia le WOCBP sia gli uomini in età fertile dovranno essere disposti e in grado di utilizzare metodi contraccettivi altamente efficaci secondo le linee guida ICH M3 (R2) che, se usati con costanza e correttamente, siano associati a un basso tasso di insuccesso (inferiore all’1% all’anno), preferibilmente con una scarsa dipendenza dall’utilizzatore, insieme a un metodo di barriera aggiuntivo. Nel foglio informativo per il paziente e nel paragrafo 4.2.2.4 sono riportati un elenco dei metodi anticoncezionali che soddisfano questi criteri e istruzioni relative alla durata del loro utilizzo.
2. Ottenimento del consenso informato scritto firmato e datato prima dell’ammissione nello studio in conformità alla buona pratica clinica (GCP) e alla legislazione locale.
3. Pazienti di età = 18 e = 85 anni al momento della firma del consenso informato.
Storia clinica compatibile con bronchiectasia (tosse, produzione cronica di espettorato e/o infezioni respiratorie ricorrenti) e diagnosi di bronchiectasia alla tomografia computerizzata (TC) confermata dallo sperimentatore. I soggetti di cui non siano disponibili precedenti referti radiografici del torace saranno sottoposti a una tomografia computerizzata (TC) del torace durante lo screening. I vecchi referti non dovranno risalire a oltre 5 anni prima.
5. Storia di esacerbazioni polmonari necessitanti di trattamento antibiotico. Nei 12 mesi antecedenti la visita 1, i pazienti dovranno aver presentato:
a. almeno 2 esacerbazioni o
b. almeno 1 esacerbazione e un punteggio dei sintomi nel Saint George’s Respiratory Questionnaire (SGRQ) > 40 alla visita 1 di screening.
Nei pazienti in terapia stabile con antibiotici orali o per via inalatoria come trattamento cronico per la bronchiectasia dovrà essersi manifestata almeno un’esacerbazione dall’inizio della terapia antibiotica stabile (vedere tabella 4.2.2.1: 1).
6. Pazienti che attualmente producono espettorato con storia di espettorazione cronica in grado di fornire un campione di espettorato spontaneo (non indotto) alla visita 1 di screening.
(1) Le donne sono considerate in età fertile (WOCBP) a partire dal menarca e fino alla postmenopausa, eccetto i casi di sterilità permanente.
I metodi di sterilizzazione permanente includono isterectomia, salpingectomia bilaterale e ovariectomia bilaterale.
La legatura delle tube NON è un metodo di sterilizzazione permanente.
Lo stato postmenopausale è definito come l’assenza di mestruazioni per 12 mesi senza causa medica alternativa.

E.4

Principal exclusion criteria

- AST and / or ALT >3.0 x ULN at Visit 1
- Estimated glomerular filtration rate (eGFR) according to CKD-EPI
formula < 30 mL/min at Visit 1.
- An absolute blood neutrophil count <1,000/mm3 at Visit 1.
- Any clinically relevant finding in the medical examination (including BP,
PR, or ECG) and/or laboratory value assessed by the Investigator at
Screening Visit 1 or during screening period.
- Positive serological tests for hepatitis B, hepatitis C, or human
immunodeficiency virus (HIV) infection, or known infection status.

Further criteria apply (see protocol).

Test di laboratorio ed esame obiettivo
1. Aspartato aminotransferasi (AST) e/o alanina aminotransferasi (ALT) > 3,0 volte il limite superiore della norma (ULN) alla visita 1.
2. Velocità di filtrazione glomerulare stimata (eGFR) calcolata con l’equazione sviluppata dalla Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 30 mL/min alla visita 1.
3. Conta assoluta dei neutrofili nel sangue < 1.000/mm3 alla visita 1.
4. Qualsiasi riscontro all’esame obiettivo (compresi pressione arteriosa [PA], frequenza cardiaca [FC] o elettrocardiogramma [ECG]) e/o valore di laboratorio clinicamente rilevante secondo quanto valutato dallo sperimentatore alla visita 1 di screening o durante il periodo di screening. [I parametri di laboratorio relativi alla visita 1 dovranno soddisfare i valori soglia sopra indicati. I risultati di laboratorio della visita 2 saranno disponibili solo dopo la randomizzazione. Nel caso in cui, alla visita 2, i risultati non soddisfacessero più i criteri di ingresso, lo sperimentatore dovrà decidere se la permanenza del paziente nello studio sia giustificata. La giustificazione della decisione dovrà essere documentata].
5. Test sierologici positivi per infezione da virus dell’epatite B (HBV), dell’epatite C (HCV) o dell’immunodeficienza umana (HIV), oppure stato infettivo noto.

Per gli altri criteri, vedere la sinossi in italiano allegata alla documentazione

E.5 End points

E.5.1

Primary end point(s)

1) Time to first pulmonary exacerbation up to 48 weeks after first drug
adminstration

1) L'endpoint primario è il tempo alla prima esacerbazione polmonare fino a 48 settimane.

E.5.1.1

Timepoint(s) of evaluation of this end point

1) 48 weeks

1) 48 settimane

E.5.2

Secondary end point(s)

1) Relative change from baseline in neutrophil elastase (NE) activity in
sputum at week 12 after first drug administration
2) Rate of pulmonary exacerbations (number of events per person-time up to week 48 after first drug administration
3) Absolute change from baseline in St. George's Respiratory
Questionnaire (SGRQ) Symptoms score at week 24 after first drug
administration
4) Absolute change from baseline in percent predicted postbronchodilator
forced expiratory volume in one second (FEV1%pred) at
week 24 after first drug administration
5) Occurrence of an exacerbation by week 24 after first drug
administration

1) Variazione relativa rispetto al basale dell'attività dell’elestasi neutrofila (NE) nell'espettorato alla settimana 12.
2) Tasso di esacerbazioni polmonari fino alla settimana 48.
3) Variazione assoluta rispetto al basale del punteggio dei sintomi SGRQ alla settimana 24.
4) Variazione assoluta rispetto al basale del volume espiratorio forzato post-broncodilatatore previsto in percentuale in un secondo (FEV1%pred) alla settimana 24
5) Insorgenza di una esacerbazione entro la settimana 24

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 12
2) up to week 48
3) week 24
4) week 24
5) week 24

1) settimana 12
2) fino a settimana 48
3) settimana 24
4) settimana 24
5) 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

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)

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

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

Belgium

Bulgaria

Canada

Czechia

Denmark

France

Germany

Greece

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Lithuania

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

Spain

Turkey

Ukraine

United Kingdom

United States

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

140

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

131

F.4.2.2

In the whole clinical trial

240

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

nessuno

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

2022-03-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-22

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

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