Clinical Trials Register

Summary
EudraCT Number:	2022-001091-34
Sponsor's Protocol Code Number:	1305-0014
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-08-04
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

France - ANSM

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)

Etude en double aveugle, randomisée, contrôlée versus placebo, évaluant l’efficacité et la sécurité du BI 1015550 pendant au moins 52 semaines chez des patients présentant une Fibrose Pulmonaire Idiopathique (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)

Etude pour déterminer si le BI 1015550 améliore la fonction pulmonaire des personnes atteintes de Fibrose Pulmonaire Idiopathique (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 France
B.1.3.4	Country	France
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 France
B.4.2	Country	France
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	QRPE PSC CT Information Disclosure
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	+18002430127
B.5.5	Fax number	+18008217119
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	BI 1015550 9 mg Film Coated Tablet
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.3.9.3	Other descriptive name	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	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	BI 1015550 18 mg Film Coated Tablet
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.3.9.3	Other descriptive name	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	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	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)

Fibrose Pulmonaire Idiopathique (IPF)

E.1.1.1

Medical condition in easily understood language

Fibrosis of the lungs of unidentified origin

Fibrose des poumons d'origine non identifiée

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10021240
E.1.2	Term	Idiopathic pulmonary fibrosis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

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'objectif principal est de démontrer une diminution du déclin de la fonction pulmonaire, mesurée par le changement par rapport à l’état initial de la Capacité Vitale Forcée (CVF), avec le BI 1015550 par rapport au placebo chez les patients atteints de 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.

L'objectif secondaire principal est de démontrer la capacité du BI 1015550 à réduire la survenue d'événements cliniquement significatifs tels que les exacerbations aiguës de FPI, les hospitalisations pour cause respiratoire ou les décès pendant la durée de l'étude par rapport au placebo chez les patients atteints de FPI. Un autre objectif secondaire de l'essai est de montrer un effet du BI 1015550 sur les symptômes et la fonction pulmonaire.

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

Patients ≥40 ans au moment de la signature du consentement
Diagnostic de FPI basée sur les guidelines 2022 ATS/ERS/JRS/ALAT
CVF ≥45% de la valeur normale prédite
DLCO ≥25% et <90% de la valeur normale prédite
Traités par nintedanib ou pirfenidone stable depuis au moins 12 semaines ou non traités par nintedanib ou pirfenidone au cours des 8 dernières semaines

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

E.5 End points

E.5.1

Primary end point(s)

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

Changement en valeur absolue par rapport à l’état initial de la CVF (mL) à la Semaine 52

E.5.1.1

Timepoint(s) of evaluation of this end point

52 weeks

52 semaines

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) Critère secondaire principal : délai avant la première survenue de l’un des composants du critère composite : délai avant la première exacerbation aiguë de FPI, avant la première hospitalisation pour cause respiratoire, ou décès (quel que soit le premier qui survient) pendant toute la durée de l’étude.
2) Délai avant la première exacerbation aigüe de FPI ou décès pendant la durée de l'étude
3) Délai avant hospitalisation pour cause respiratoire ou décès pendant la durée de l'étude
4) Délai avant le déclin absolu >10% de la CVF en % de la valeur prédite par rapport à l'état initial ou décès pendant la durée de l'étude
5) Délai avant le déclin absolu >15% de la DLCO en % de la valeur prédire par rapport à l'état initial ou décès pendant la durée de l'étude
6) Délai avant décès pendant la durée de l'étude
7) Changement absolu par rapport à l'état initial du score du domaine
Symptômes Dyspnée du questionnaire Living with Pulmonary Fibrosis (LPF)
à la semaine 52
8) Changement absolu par rapport à l'état initial du score du domaine
Symptômes Toux du questionnaire Living with Pulmonary Fibrosis (L-PF)
à la semaine 52
9) Changement absolu par rapport à l'état initial du score du domaine
Symptômes Fatigue du questionnaire Living with Pulmonary Fibrosis (LPF)
à la semaine 52
10) Changement absolu par rapport à l'état initial de la CVF en % de la
valeur prédite à la semaine 52
11) Changement absolu par rapport à l'état initial de la DLCO en % de la
valeur prédite à la semaine 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 mois
2) 30 mois
3) 30 mois
4) 30 mois
5) 30 mois
6) 30 mois
7) 52 semaines
8) 52 semaines
9) 52 semaines
10) 52 semaines
11) 52 semaines

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.8.5

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

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

Serbia

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

LVLS

Dernière visite du dernier patient

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

Les patients ayant complété l'étude sous traitement se verront offrir la possibilité d'entrer dans une étude en ouvert avec seulement le traitement actif BI 1015550. La dose sera déterminée pendant le déroulement de cette étude de phase 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

2022-12-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-12

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

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