Clinical Trials Register

Summary
EudraCT Number:	2022-001091-34
Sponsor's Protocol Code Number:	1305-0014
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:	2022-10-21
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

2022-001091-34

A.3

Full title of the trial

A double blind, randomized, placebo-controlled trial evaluating
the efficacy and safety of BI 1015550 over at least 52 weeks in
patients with Idiopathic Pulmonary Fibrosis (IPF)

Studio in doppio cieco, randomizzato, controllato verso placebo volto a valutare l'efficacia e la sicurezza di BI 1015550 somministrato per almeno 52 settimane in pazienti con fibrosi polmonare idiopatica (FPI)

A.3.1

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

A study to find out whether BI 1015550 improves lung function
in people with Idiopathic Pulmonary Fibrosis (IPF)

Studio volto a valutare il miglioramento della funzionalità polmonare, a seguito del trattamento con BI 1015550, in soggetti con fibrosi polmonare idiopatica (FPI)

A.3.2

Name or abbreviated title of the trial where available

FIBRONEER-IPF

A.4.1

Sponsor's protocol code number

1305-0014

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
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	55126
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 1015550]
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 1015550
D.3.9.4	EV Substance Code	SUB250067
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	9
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 1015550]
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 1015550
D.3.9.4	EV Substance Code	SUB250067
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	18
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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Idiopathic Pulmonary Fibrosis (IPF)

fibrosi polmonare idiopatica (FPI)

E.1.1.1

Medical condition in easily understood language

Fibrosis of the lungs of unidentified origin

fibrosi polmonare idiopatica (FPI)

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to demonstrate a reduction in lung function
decline as measured by the change from baseline in FVC for
BI 1015550 when compared to placebo in patients with IPF.

L'obiettivo primario è dimostrare una riduzione nel declino della funzione polmonare, misurata come variazione rispetto al basale della FVC per BI 1015550 rispetto al placebo nei/nelle pazienti con FPI.

E.2.2

Secondary objectives of the trial

The main secondary objective of the trial is to demonstrate
BI 1015550’s ability in reducing the occurrence of clinically
meaningful events such as acute IPF exacerbation, hospitalization
for respiratory cause or death over the duration of the trial when
compared to placebo in patients with IPF. An additional secondary
objective of the trial is to show an effect of BI 1015550 on
symptoms and lung function.

Il principale obiettivo secondario della sperimentazione è dimostrare la capacità di BI 1015550 nel ridurre l’insorgenza di eventi clinicamente significativi quali l’esacerbazione acuta della FPI, il ricovero per causa respiratoria o il decesso durante la sperimentazione rispetto al placebo in pazienti affetti/e da FPI. Un ulteriore obiettivo secondario della sperimentazione è dimostrare un effetto di BI 1015550 sui sintomi e sulla funzionalità polmonare.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients >=40 years old at the time of signed consent
IPF diagnosis based on 2022 ATS/ERS/JRS/ALAT Guidelines
FVC >=45% of predicted normal
DLCO >=25% and <90% predicted of normal
On stable treatment with nintedanib or pirfenidone for at least
12 weeks or not on treatment with either nintedanib or
pirfenidone for at least 8 weeks

1. Pazienti di età >=40 anni al momento della firma del consenso informato.
2. Consenso informato scritto firmato e datato in accordo con le ICH-GCP e la normativa locale prima dell’ammissione alla sperimentazione.
3. Diagnosi di fibrosi polmonare idiopatica.
4. I/Le pazienti possono essere:
- in terapia stabile* con nintedanib o pirfenidone per almeno 12 settimane prima della Visita 1 e durante lo screening e intendono proseguire questo trattamento di base dopo la randomizzazione. La combinazione di nintedanib più pirfenidone non è consentita.
*la terapia stabile è definita come il regime tollerato individualmente e in generale di nintedanib o pirfenidone (senza nessuna modifica della dose) per almeno 12 settimane.
- senza trattamento con nintedanib o pirfenidone da almeno 8 settimane prima della Visita 1 e durante il periodo di screening (ad es. naïve al trattamento per AF o precedente interruzione) e non prevedono di iniziare o riprendere il trattamento antifibrotico.
5. Capacità vitale forzata (FVC) >=45% del normale previsto alla Visita 1.
6. DLCO corretta per emoglobina (Hb) [Visita 1] >=25% e <90% del valore normale previsto alla Visita 1.
7. Le donne in età fertile (WOCBP) devono essere disposte ed essere in grado di usare metodi contraccettivi altamente efficaci. Si noti che i contraccettivi ormonali orali non sono considerati un metodo altamente efficace a causa di potenziali interazioni tra farmaci.

E.4

Principal exclusion criteria

Relevant airways obstruction (prebronchodilator FEV1/FVC
<0.7)
Acute IPF exacerbation within 3 months and/or during the
screening period
Treated with immunomodulatory medications (other than oral
corticosteroids) or prednisone >15 mg/day or equivalent for
respiratory or pulmonary reasons
Active, unstable or uncontrolled vasculitis within 8 weeks
Any suicidal behaviour in the past 2 years
Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months

1. Ostruzione rilevante delle vie aeree (FEV1/FVC prebroncodilatatore <0,7) alla Visita 1.
2. A giudizio dello sperimentatore, altre anomalie polmonari clinicamente significative.
3. Esacerbazione acuta della FPI entro 3 mesi prima della Visita 1 e/o durante il periodo di screening (determinata dallo sperimentatore).
4. Infezioni croniche o acute rilevanti, comprese le infezioni da virus dell’immunodeficienza umana (HIV) ed epatiti virali.
5. Infezione confermata da SARS-CoV-2 non completamente recuperata a giudizio dello sperimentatore entro le 4 settimane precedenti la randomizzazione (Visita 2).
6. Intervento chirurgico importante (in base alla valutazione dello sperimentatore) eseguito nelle 6 settimane precedenti la Visita 2 o programmato durante il periodo della sperimentazione, ad es. sostituzione dell’anca. L’iscrizione alla lista di trapianto polmonare non è considerata un intervento chirurgico importante programmato.
7. Qualsiasi neoplasia maligna attiva o sospetta documentata o anamnesi di neoplasia maligna nei 5 anni precedenti la Visita 1, ad eccezione di carcinoma cutaneo basocellulare adeguatamente trattato, carcinoma cutaneo in situ a cellule squamose o carcinoma in situ della cervice uterina.
8. AST o ALT > 2,5 x ULN o bilirubina totale > 1,5 x ULN alla Visita 1.
9. eGFR <=30 ml/min/1,73 m2 alla Visita 1. (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] o versione giapponese del CKD-EPI per pazienti giapponesi)
Per gli altri criteri rifarsi alla sinossi in italiano

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the absolute change from baseline in Force Vital
Capacity (FVC) [mL] at Week 52.

l'endpoint primario è la variazione assoluta rispetto al basale della FVC [ml] alla Settimana 52.

E.5.1.1

Timepoint(s) of evaluation of this end point

52 weeks

settimana 52

E.5.2

Secondary end point(s)

1) key secondary endpoint: time to the first occurrence of any of the
components of the composite endpoint: time to first acute IPF
exacerbation, first hospitalization for respiratory cause, or death
(whichever occurs first) over the duration of the trial
2) Time to first acute IPF exacerbation or death over the duration of the
trial
3) Time to hospitalization for respiratory cause or death over the
duration of the trial
4) Time to absolute decline in FVC % predicted of >10% from baseline
or death over the duration of the trial
5) Time to absolute decline in (DLCO) % predicted of >15% from
baseline or death over the duration of the trial
6) Time to death over the duration of the trial
7) Absolute change from baseline in Living with Pulmonary Fibrosis
(LPF) Symptoms Dyspnea domain score at Week 52
8) Absolute change from baseline in Living with Pulmonary Fibrosis
(LPF) Symptoms Cough domain score at Week 52
9) Absolute change from baseline in Living with Pulmonary Fibrosis
(LPF) Symptoms Fatigue domain score at Week 52
10) Absolute change from baseline in FVC % predicted at Week 52
11) Absolute change from baseline in DLCO % predicted at Week 52

1) endpoint secondario chiave: tempo alla prima occorrenza di uno qualsiasi dei
componenti dell'endpoint composito: tempo alla prima FPI acuta
esacerbazione, primo ricovero per causa respiratoria o morte
(a seconda di quale evento si verifica per primo) per tutta la durata del processo
2) Tempo alla prima esacerbazione acuta della FPI o alla morte per tutta la durata del
prova
3) Tempo al ricovero per causa respiratoria o morte oltre il
durata del processo
4) Tempo al declino assoluto della % di FVC previsto di >10% rispetto al basale
o morte per tutta la durata del processo
5) Tempo al declino assoluto (DLCO) % previsto di >15% da
basale o morte per tutta la durata dello studio
6) Tempo alla morte per tutta la durata del processo
7) Cambiamento assoluto rispetto al basale in Living with Pulmonary Fibrosis
(LPF) Sintomi Punteggio del dominio della dispnea alla settimana 52
8) Cambiamento assoluto rispetto al basale in Living with Pulmonary Fibrosis
(LPF) Sintomi Punteggio del dominio della tosse alla settimana 52
9) Cambiamento assoluto rispetto al basale in Living with Pulmonary Fibrosis
(LPF) Sintomi Punteggio del dominio della fatica alla settimana 52
10) Variazione assoluta rispetto al basale della percentuale di CVF prevista alla settimana 52
11) Variazione assoluta rispetto al basale della % di DLCO prevista alla settimana 52

E.5.2.1

Timepoint(s) of evaluation of this end point

1) 30 months
2) 30 months
3) 30 months
4) 30 months
5) 30 months
6) 30 months
7) 52 weeks
8) 52 weeks
9) 52 weeks
10) 52 weeks
11) 52 weeks

1) 30 mesi
2) 30 mesi
3) 30 mesi
4) 30 mesi
5) 30 mesi
6) 30 mesi
7) 52 settimane
8) 52 settimane
9) 52 settimane
10) 52 settimane
11) 52 settimane

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

164

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

Egypt

India

Israel

Japan

Korea, Republic of

Malaysia

Mexico

New Zealand

Saudi Arabia

Singapore

South Africa

Taiwan

Thailand

United States

Austria

Estonia

Finland

France

Poland

Sweden

Netherlands

Spain

Switzerland

Czechia

Germany

Greece

Italy

Belgium

Croatia

Denmark

Georgia

Hungary

Ireland

Norway

Portugal

Slovenia

Turkey

United Kingdom

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 the trial is defined as the date of the last visit of the last patient in the whole trial (“Last Patient Completed”).

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:

337

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

626

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

384

F.4.2.2

In the whole clinical trial

963

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)

The patients who have completed the trial on treatment will be offered
the opportunity to enter an open label trial with only active BI 1015550
treatment. The dose will be determined during the course of this phase
III trial

Ai pazienti che abbiano completato in trattamento il trial, verrà fornita possibilità di partecipare ad una sperimentazione in aperto, con il solo trattamento attivo BI 1015550. La dose sarà determinata nel corso del suddetto trial di fase III

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

2022-11-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-22

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

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