Clinical Trials Register

Summary
EudraCT Number:	2022-001134-11
Sponsor's Protocol Code Number:	1305-0023
National Competent Authority:	Slovenia - JAZMP
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-10-06
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

Slovenia - JAZMP

A.2

EudraCT number

2022-001134-11

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 Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Dvojno slepo, randomizirano, s placebom kontrolirano preskušanje, ki ocenjuje učinkovitost in varnost BI 1015550 v vsaj 52 tednih pri bolnikih s progresivno fibrozno intersticijsko pljučno boleznijo (PF-ILD)

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 Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

A.3.2

Name or abbreviated title of the trial where available

PDE4 Phase III trial in PF-ILD (Fibroneer- ILD)

A.4.1

Sponsor's protocol code number

1305-0023

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 RCV GmbH & Co KG
B.1.3.4	Country	Austria
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 RCV GmbH & Co KG
B.4.2	Country	Austria
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	DaCT 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	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	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.3.8	INN - Proposed INN	None yet
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.3.8	INN - Proposed INN	None yet
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

Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

progresivno fibrozno intersticijsko pljučno boleznijo (PF-ILD)

E.1.1.1

Medical condition in easily understood language

Progressive Fibrosing Interstitial Lung Disease

progresivno fibrozno intersticijsko pljučno boleznijo

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	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084309
E.1.2	Term	Progressive fibrosing interstitial lung disease
E.1.2	System Organ Class	100000004855

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 trial will evaluate efficacy and safety of BI 1015550.
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
progressive fibrosing ILDs.

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 ILD exacerbations, hospitalization for respiratory cause or death over the duration of the trial when compared to placebo in patients with progressive fibrosing ILDs.
An additional secondary objective of the trial is to show an effect of BI 1015550 on symptoms and lung function.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients ≥18 years old at the time of signed informed consent.
2. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial.
3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed;
Section 3.3.1)
4. Patients may be either:
-- on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. *stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks.
-- not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either AF-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
5. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
6. DLCO corrected for Hemoglobin (Hb) [Visit 1] ≥25% and <90% predicted of normal at Visit 1.
7. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions.
8. Patients treated with permitted immunosuppressive agents for an underlying systemic disease (e.g. MTX, AZA) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.

E.4

Principal exclusion criteria

1. Relevant airways obstruction (prebronchodilator FEV1/FVC <0.7) at Visit 1
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
5. Patients having developed ILD due to SARS-CoV-2 infection/COVID-19 within 12 months of screening (based on investigators judgement).
6. Major surgery (major according to the investigator’s assessment) performed within
6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.
7. 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, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
8. AST or ALT >2.5 x ULN or total Bilirubin >1.5 x ULN at Visit 1.
9. eGFR ≤30 mL/min/1.73 m2 at Visit 1. (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula or Japanese version of CKD-EPI for Japanese patients)
10. Patients with underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment).
11. Cardiovascular diseases, any of the following:
a. Severe hypertension (uncontrolled under treatment ≥160/100 mmHg at multiple occasions) within 3 months of Visit 1
b. Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1
c. Unstable cardiac angina within 6 months of Visit 1
12. Use of any of the following medications: prednisone >15mg/day or equivalent within 4 weeks of Visit 1; cyclophosphamide, tocilizumab, mycophenolate, pirfenidone within 8 weeks of Visit 1; rituximab within 6 months of Visit 1.

Further criteria apply.

E.5 End points

E.5.1

Primary end point(s)

1) absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52

E.5.1.1

Timepoint(s) of evaluation of this end point

1) 52 weeks

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 (L-PF) Symptoms Dyspnea domain score at Week 52
8) Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
9) Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) 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

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

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

179

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

Russian Federation

Slovenia

Turkey

Ukraine

United Kingdom

Serbia

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:

600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

441

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Prior to patient participation in the trial, written informed consent must be obtained from each patient (or the patient’s legally accepted representative).

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

409

F.4.2.2

In the whole clinical trial

1041

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

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

2023-06-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-06-07

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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