Clinical Trials Register

Summary
EudraCT Number:	2018-000525-32
Sponsor's Protocol Code Number:	1199-0248
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:	2021-06-15
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

2018-000525-32

A.3

Full title of the trial

An open-label extension trial of the long term safety of nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Studio di estensione in aperto sulla sicurezza a lungo termine di nintedanib in pazienti con pneumopatia interstiziale fibrosante progressiva (PF-ILD)

A.3.1

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

A follow-up study investigating long term treatment with nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Uno studio di prosecuzione sul trattamento a lungo termine con nintedanib in pazienti con pneumopatia interstiziale fibrosante progressiva (PF-ILD)

A.3.2

Name or abbreviated title of the trial where available

Nintedanib in PF-ILD (extension)

Nintedanib in PF-ILD (studio di estensione)

A.4.1

Sponsor's protocol code number

1199-0248

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
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	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	00498002430127
B.5.5	Fax number	00498008217119
B.5.6	E-mail	clintriage.rdg@boehringeringelheim.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	Yes
D.2.1.1.1	Trade name	Ofev
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Nintedanib 150mg capsules
D.3.2	Product code	[Nintedanib]
D.3.4	Pharmaceutical form	Capsule, soft
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	NINTEDANIB
D.3.9.1	CAS number	656247-17-5
D.3.9.2	Current sponsor code	Nintedanib
D.3.9.4	EV Substance Code	SUB120728
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	150
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	Yes
D.2.1.1.1	Trade name	Ofev
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Nintedanib 100 mg capsules
D.3.2	Product code	[Nintedanib]
D.3.4	Pharmaceutical form	Capsule, soft
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	NINTEDANIB
D.3.9.1	CAS number	656247-17-5
D.3.9.2	Current sponsor code	Nintedanib
D.3.9.4	EV Substance Code	SUB120728
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	100
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

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 Disease (PF-ILD)

pneumopatia interstiziale fibrosante progressiva (PF-ILD)

E.1.1.1

Medical condition in easily understood language

Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

pneumopatia interstiziale fibrosante progressiva (PF-ILD)

E.1.1.2

Therapeutic area

Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10066393
E.1.2	Term	Respiratory bronchiolitis-associated 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 main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have completed (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247)

L’obiettivo primario è valutare la tollerabilità e la sicurezza a lungo termine del trattamento con nintedanib per via orale in pazienti con pneumopatia interstiziale fibrosante progressiva che abbiano completato (e non abbiano interrotto prematuramente il farmaco dello studio) lo studio madre di fase III 1199.247 (INBUILD®)

E.2.2

Secondary objectives of the trial

Not applicable

non applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Women of childbearing potential (WOCBP) must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

1. Pazienti di sesso maschile o femminile che abbiano completato lo studio INBUILD® come pianificato e che e non abbiano interrotto prematuramente il trattamento in doppio cieco.
2. Consenso informato scritto conforme alle linee guida ICH-GCP e alla legislazione locale firmato e datato prima dell'ingresso nello studio
3. Le donne in età fertile (WOCBP) devono continuare ad usare metodi per il controllo delle nascite altamente efficaci secondo le linee guida ICH M3 (R2) associati a un tasso di fallimento basso inferiore all'1% annuo se usati costantemente e correttamente, unitamente ad un metodo barriera nel lasso di tempo compreso tra 28 giorni prima e 3 mesi dopo la somministrazione di nintedanib. Il foglio informativo per il paziente contiene un elenco dei metodi anticoncezionali che soddisfano questi criteri.

E.4

Principal exclusion criteria

1. Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator’s benefit-risk assessment remains favourable.
2. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
3. Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator’s judgement.
4. Previous enrolment in this trial.
5. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
6. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

1. Qualsiasi malattia che possa mettere il paziente a rischio nel corso della sua partecipazione allo studio. Riconsiderare attentamente tutti i criteri di esclusione dello studio INBUILD®. Tuttavia un paziente potrebbe essere idoneo per la partecipazione, nonostante abbia soddisfatto dei criteri di esclusione nel corso della partecipazione all’INBUILD®, qualora lo sperimentatore ritenga che il rapporto beneficio-rischio rimanga favorevole.
2. Pazienti che debbano o desiderino proseguire l’assunzione di farmaci non consentiti o farmaci che potrebbero interferire con la conduzione in sicurezza della sperimentazione.
3. Mancata adesione alle procedure relative al farmaco sperimentale o alle visite dello studio nella sperimentazione madre (INBUILD®), a giudizio dello sperimentatore.
4. Precedente reclutamento in questa sperimentazione.
5. Alcolismo o tossicodipendenza o qualsiasi condizione che, a giudizio dello sperimentatore, renda il paziente un partecipante alla sperimentazione non affidabile o con scarsa probabilità di completare la sperimentazione.
6. Donne in stato di gravidanza, allattamento o che prevedano di intraprendere una gravidanza nel corso della sperimentazione.

E.5 End points

E.5.1

Primary end point(s)

1. The primary endpoint is the incidence of overall adverse events over the course of this extension trial.

1. Incidenza degli eventi avversi nel corso della sperimentazione di estensione.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. End of trial

1. termine della sperimentazione

E.5.2

Secondary end point(s)

1. No secondary efficacy endpoints are defined.

nessuno

E.5.2.1

Timepoint(s) of evaluation of this end point

1. No secondary efficacy endpoints are defined.

nessuno

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

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

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

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

Canada

Chile

China

Japan

Korea, Republic of

Russian Federation

United States

Belgium

France

Germany

Italy

Poland

Spain

United Kingdom

Argentina

E.8.7

Trial has a data monitoring committee

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:

335

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

145

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

192

F.4.2.2

In the whole clinical trial

480

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)

Patients will receive nintedanib outside of a trial (either marketed product or as part of a CUP or EAP)

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

2019-05-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-23

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

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