Clinical Trials Register

Summary
EudraCT Number:	2019-004167-45
Sponsor's Protocol Code Number:	1305-0013
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-17
Trial results	View 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

2019-004167-45

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.

Studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli di 12 settimane, su pazienti con fibrosi polmonare idiopatica volto a valutare efficacia, sicurezza e tollerabilità di BI 1015550 somministrato per via orale

A.3.1

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

A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).

Studio per valutare come BI 1015550, preso per 12 settimane, influisca sulle funzionalità polmonari di pazienti con fibrosi polmonare idiopatica

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

1305-0013

A.5.4

Other Identifiers

Name:

Number:

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 and 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	+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	-
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	SUB187131
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	6
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.3.9.3	Other descriptive name	BI 1015550
D.3.9.4	EV Substance Code	SUB187131
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	12
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

fibrosi polmonare idiopatica

E.1.1.1

Medical condition in easily understood language

Idiopathic Pulmonary Fibrosis

fibrosi polmonare idiopatica

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

- To investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in Forced Vital Capacity (FVC).
- To investigate safety and tolerability of BI 1015550 in the overall trial population.

Studiare l’efficacia di BI 1015550 18 mg due volte/die a confronto con il placebo in base alla variazione rispetto al basale della FVC (capacità vitale forzata, Forced Vital Capacity). Studiare la sicurezza e la tollerabilità di BI 1015550 nella popolazione complessiva dello studio.

E.2.2

Secondary objectives of the trial

Not applicable

Non Applicabile

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: -Digital lung Auscultation Test (substudy at dedicated sites only) Electronic recordings of lung auscultation sounds will be collected
-24 hr Cough measurement (substudy at dedicated sites only) 24 hr record of patient's daily sound will be collected via a device installed on the patient

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Procedure opzionali sulla registrazione dei suoni polmonari e per la valutazione della tosse delle 24 ore che saranno attivate successivamente e comporteranno la sottomissione di consensi informati specifici

E.3

Principal inclusion criteria

- Patients aged >=40 years when signing the informed consent.
- Diagnosis:
-- a. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline [R18-2794] as
confirmed by the investigator based on chest HRCT scan taken within 12
months of Visit 1 and if available surgical lung biopsy. and
-- b. UIP or probable UIP HRCT pattern consistent with the clinical
diagnosis of IPF
- Stable for at least 8 weeks prior to Visit 1. Patients have to be either :
-- not on therapy with nintedanib or pirfenidone for at least 8 weeks
prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed),
or
-- on stable* therapy with nintedanib or pirfenidone for at least 8 weeks
prior to Visit 1 and planning to stay stable on this background therapy
after randomisation.
- Forced Vital Capacity (FVC) >=45% of predicted normal at Visit 1
- DLCO (corrected for haemoglobin [Hb] [Visit 1]) >= 25% to < 80% of
predicted normal at Visit 1.
- Signed and dated written informed consent in accordance with ICHGCP
and local legislation prior to admission to the trial.

1. Pazienti di età >=40 anni che abbiano firmato il consenso informato.
2. Diagnosi: per informazioni dettagliate, si veda anche l’Appendice 10.5
a. IPF secondo le linee guida ATS/ERS/JRS/ALAT 2018 [R18-2794], come confermato dallo sperimentatore in base all’HRCT del torace eseguita nei 12 mesi precedenti la Visita 1 e alla biopsia polmonare chirurgica, se disponibile.
e
b. Pattern UIP o probabile pattern UIP all’HRCT compatibile con la diagnosi clinica di IPF, come confermato dalla revisione centralizzata prima della Visita 2*
*in caso di un reperto indeterminato all’HRCT, l’IPF può essere confermata a livello locale mediante biopsia (storica)
3. Stabili da almeno 8 settimane prima della Visita 1. I pazienti devono essere:
• non in terapia con nintedanib o pirfenidone da almeno 8 settimane prima della Visita 1 (non è consentita l’associazione di nintedanib e pirfenidone), oppure
• in terapia stabile* con nintedanib o pirfenidone da almeno 8 settimane prima della Visita 1 e con previsione di proseguire stabilmente questa terapia di base dopo la randomizzazione.
[*si definisce “terapia stabile” il regime di trattamento con pirfenidone o nintedanib generalmente tollerato dal singolo paziente]
4. Capacità vitale forzata (FVC) >=45% del normale predetto alla Visita 1
5. DLCO (capacità di diffusione per il monossido di carbonio (Diffusion capacity of the Lung for Carbon monoxide)) (corretta per l’emoglobina [Hb] [Visita 1]) da >=25% a <80% del normale predetto alla Visita 1.
6. Pazienti che abbiano datato e firmato il consenso informato secondo i principi di GCP dell’ICH e la legislazione locale prima dell’ammissione nello studio.

E.4

Principal exclusion criteria

- Relevant airways obstruction (pre-bronchodilator FEV1/FVC < 0.7) at
Visit 1.
- In the opinion of the Investigator, other clinically significant pulmonary
abnormalities.
- Acute IPF exacerbation within 4 months prior to screening and/or
during the screening period (investigator-determined).
- Lower respiratory tract infection requiring antibiotics within 4 weeks
prior to Visit 1 and/or during the screening period.
- Major surgery (major according to the investigator's assessment)
performed within 3 months prior to Visit 1 or planned during the course
of the trial. (Being on a transplant list is allowed).
- Any documented active or suspected malignancy or history of
malignancy within 5 years prior to Visit 1, except appropriately treated
basal cell carcinoma of the skin, "under surveillance" prostate cancer or
in situ carcinoma of uterine cervix.
- Evidence of active infection (chronic or acute) based on clinical exam
or laboratory findings (see table 5.2.3 :1) at Visit 1 or at Visit 2.
- Any suicidal behaviour in the past 2 years (i.e. actual attempt,
interrupted attempt, aborted attempt, or preparatory acts or behavior).
- Further criteria apply.

1. Ostruzione delle vie aeree rilevante (FEV1 (volume espiratorio forzato in un secondo)/FVC <0,7 prima della broncodilatazione) alla Visita 1.
2. Altre anomalie polmonari clinicamente significative secondo il giudizio dello sperimentatore.
3. Riacutizzazione acuta dell’IPF nei 4 mesi precedenti lo screening e/o durante il periodo di screening (determinata dallo sperimentatore).
4. Infezione delle basse vie respiratorie che richiede l’impiego di antibiotici nelle 4 settimane precedenti la Visita 1 e/o durante il periodo di screening.
5. Intervento di chirurgica maggiore (“maggiore” secondo la valutazione dello sperimentatore) eseguito nei 3 mesi precedenti la Visita 1 o programmato nel corso della sperimentazione. (È consentita la partecipazione di pazienti in lista per trapianto).
6. Qualsiasi neoplasia maligna in atto documentata o sospetta o anamnesi positiva per neoplasia maligna nei 5 anni precedenti la Visita 1, a eccezione di forme adeguatamente trattate di carcinoma cutaneo basocellulare, carcinoma prostatico “sotto sorveglianza” o carcinoma in situ della cervice uterina.
7. Evidenze di infezione in atto (cronica o acuta) secondo l’esame clinico o i reperti di laboratorio (si veda la Tabella 5.2.3 :1) alla Visita 1 o alla Visita 2.
8. Comportamenti suicidari negli ultimi 2 anni (ovvero, tentativo concreto, tentativo interrotto, tentativo fallito, oppure comportamenti o atti preparatori).
9. Ideazioni suicidarie di tipo 4 o 5 secondo la C-SSRS (Columbia Suicidal Severity Rating Scale) negli ultimi 3 mesi o alla Visita 1 (ovvero, ideazione suicidaria attiva con un metodo e intenzione di agire, ma senza un piano specifico; oppure ideazione suicidaria attiva con un metodo, un piano e con intenzione).

Per altri criteri fare riferimento alla sinossi del protocollo in italiano

E.5 End points

E.5.1

Primary end point(s)

1) The primary endpoint is the change from baseline in FVC

1) L’endpoint primario è la variazione rispetto al basale della FVC

E.5.1.1

Timepoint(s) of evaluation of this end point

1) 12 weeks

1) 12 settimane

E.5.2

Secondary end point(s)

1) The percentage N (%) of patients with Treatment Emergent Adverse
Events (TEAE).

1) L’endpoint secondario è la percentuale di pazienti (%) N con eventi avversi emersi durante il trattamento (Treatment Emergent Adverse Events, TEAE).

E.5.2.1

Timepoint(s) of evaluation of this end point

1) 13 weeks

1) 13 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)

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

Australia

Canada

China

Japan

Korea, Republic of

Mexico

Russian Federation

Ukraine

United States

Austria

Denmark

Finland

France

Germany

Greece

Italy

Netherlands

Poland

Slovakia

Spain

United Kingdom

Czechia

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:

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

F.4.2.2

In the whole clinical trial

150

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)

nessuna

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

2020-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-04

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

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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:
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