Clinical Trials Register

Summary
EudraCT Number:	2011-002766-21
Sponsor's Protocol Code Number:	1199.33
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:	2012-06-19
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

2011-002766-21

A.3

Full title of the trial

An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)

Studio clinico di estensione in aperto per la valutazione della sicurezza a lungo termine del BIBF 1120 per somministrazione orale in pazienti con Fibrosi Polmonare Idiopatica (IPF)

A.3.1

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

Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)

Studio clinico di estensione in aperto per la valutazione della sicurezza a lungo termine del BIBF 1120 per somministrazione orale in pazienti con Fibrosi Polmonare Idiopatica (IPF)

A.4.1

Sponsor's protocol code number

1199.33

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 ING.
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	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	+1 800 243 0127
B.5.5	Fax number	+1 800 821 7119
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	BIBF 1120
D.3.2	Product code	BIBF 1120
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.3.9.2	Current sponsor code	BIBF 1120
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	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	BIBF 1120
D.3.2	Product code	BIBF 1120
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.3.9.2	Current sponsor code	BIBF 1120
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	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

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 (IPF)

E.1.1.1

Medical condition in easily understood language

Idiopathic Pulmonary Fibrosis

Fibrosi Polmonare Idiopatica (IPF)

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	14.1
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to assess long term safety of treatment with oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF).

L'obiettivo primario del presente studio e' valutare la sicurezza a lungo termine del trattamento con BIBF 1120 in pazienti con Fibrosi Polmonare Idiopatica che abbiano completato un anno di trattamento ed il relativo periodo di follow-up nello studio clinico di fase III BI 1199.32.

E.2.2

Secondary objectives of the trial

There are no secondary objectives.

non ci sono obiettivi secondari

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed Informed Consent consistent with ICH-GCP and local laws prior to trial participation. 2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

1.Firma del modulo di consenso informato in accordo alle ICH-GCP prima di partecipare allo studio 2.Pazienti che afferiscono dagli studi BI1199.32 o 1199.34 (non condotto in Italia) che abbiano completato le 52 settimane di trattamento ed il successivo periodo/visita di follow-up.

E.4

Principal exclusion criteria

1. AST, ALT > 1.5 fold ULN; Patients who completed the parent trial with transaminase values > 1.5 fold ULN but < 3 fold ULN are considered eligible. 2. Bilirubin > 1.5 fold ULN 3. Bleeding risk. 4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery. 5. New major thrombo-embolic events developed after completion of the parent trial. 6.Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study. 7. Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial. 8. A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patient's ability to participate in this trial. 9. Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation. 10. Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it until 3 months after end of treatment. 11. Sexually active men not committing to using condoms during participation in the study (except if their partner is not of childbearing potential) and 3 months after the last intake of BIBF 1120.

1.AST, ALT > 1.5 volte il ULN Pazienti che abbiano completato lo studio BI1199.32 con valori di transaminasi > 1.5 volte il ULN ma < 3 volte il ULN sono da considerarsi eleggibili. 2.Bilirubina > 1.5 volte il ULN 3.Rischio di sanguinamento: a.Pazienti che richiedono fibrinolisi, terapia anticoagulante a dosaggio pieno ( ad es. antagonisti della vitamina K, dabigatran, eparina, irudina) o terapia antipiastrinica ad alto dosaggio. Eccezioni: profilassi con eparina a basso dosaggio o flush di eparina al bisogno per mantenimento di device intravenoso (ad es. enoxaparina 4000 IU s.c. al di) ed uso profilattico di terapie antipiastrinica (ad es. acido acetil salicilico fino a 325 mg/d, o clopidogrel a 75 mg/d, o dose equivalente di altra terapia antipiastrinica); b.Eventi emorragici del CNS, emottisi o ematuria, sanguinamento od ulcerazioni attive dell'apparato gastro-intestinale dopo il completamento dello studio 1199.32; c.Seguenti parametri di coagulazione:" International normalised ratio" (INR) > 2, tempo di protrombina (PT) e tempo parziale di tromboplastina (PTT) > 150% del ULN. 4.Intervento chirurgico significativo pianificato nei successivi 3 mesi, incluso trapianto di polmone, chirurgia addominale o intestinale. 5.Nuovo evento trombo-embolico insorto dopo completamento dello studio 1199.32: a.Infarto; b.Trombosi venosa profonda; c.Embolia polmonare; d.Infarto del miocardio. 6.Se trascorrono > 12 settimane tra la Visita 9 dello studio 1199.32 e la Visita 2 del presente studio. 7.Uso di farmaco sperimentale dopo completamento dello studio 1199.32 od uso pianificato di un farmaco sperimentale specifico durante il corso dello studio. 8.Disturbo o condizione che a giudizio dello sperimentatore possa metter a rischio il paziente o limitarne la capacita' di partecipazione. 9.Abuso di alcol o droghe che a giudizio dello sperimentatore interferirebbero con la partecipazione allo studio. 10.Donne in gravidanza o allattamento o in eta' fertile che non utilizzino 2 metodi efficaci di contraccezione (uno a barriera ed uno no), per almeno 1 mese prima della visita 2 e/o non intenzionate ad usarne uno fino a 3 mesi dopo il termine del trattamento. Pazienti donne vengono considerate in eta' fertile se non sterili chirurgicamente per isterectomia o ligazione bilaterale delle tube o se in postmenopausa per almeno 2 anni. Metodi contraccettivi ad alta efficacia includono ormoni orali, iniettabili od impiantabili, device intrauterini (IUD) o sistemi intrauterini(IUS). Metodi contraccettivi a barriera includono il preservativo o cappello occlusivo con spermicida (spuma, gel, film, crema, supposta vaginale) o sterilizzazione maschile (con postvasectomia documentata e documentata assenza di sperma nell'eiaculato). 11.Uomini sessualmente attivi che non utilizzino preservativo per la durata dello studio (a meno che il partner sia NON in eta' fertile) e fino a 3 mesi dall'ultima assunzione di BIBF 1120.

E.5 End points

E.5.1

Primary end point(s)

Vital signs Physical examination including weight Clinical laboratory tests (haematology and chemistry) Adverse events, serious adverse events and significant adverse events

Poiche' si tratta di studio in aperto senza altro braccio attivo ne' placebo, non sono previsti endpoints di efficacia Endpoints di sicurezza: -Segni vitali -Esame fisico incluso il peso -Esami di laboratorio (ematochimica) -Eventi avversi, eventi avversi seri e significativi

E.5.1.1

Timepoint(s) of evaluation of this end point

The safety data will be evaluated during the whole duration of the study and analysed in interim analyses and at the end of the trial. The first Interim analysis will occur when the last patient entered will reach 48 weeks of treatment. Interim analyses will be performed every 48 weeks thereafter.

I dati di safety saranno valutati nel corso della sperimentazione come analisi ad interim ed alla fine dello studio. La prima analisi e' prevista quando l'ultimo paziente arruolato avra' terminato la quarantottesima settimana. Le altre analisi ad interim saranno fatte ogni 48 settimane

E.5.2

Secondary end point(s)

N.A.

E.5.2.1

Timepoint(s) of evaluation of this end point

N.A.

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

Yes

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

India

Israel

Japan

Korea, Republic of

Mexico

Russian Federation

Turkey

United States

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

This is an extension trial with the aim of offering treatment with BIBF 1120. The trial will stop when all patients have met a reason for withdrawal.

Studio clinico di estensione in aperto. Lo studio si concludera' quando tutti i pazienti avranno verificato criteri di esclusione/interruzione.

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

Number of subjects for this age range:

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

350

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

300

F.4.2.2

In the whole clinical trial

750

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)

This is an extension trial with the scope of providing treatment with BIBF 1120 to patients until a reason for withdrawal is met.

Studio di estensione in aperto. Lo scopo e' quello di fornire il trattamento con BIBF 1120 a tutti i pazienti inclusi nella sperimentazione fino a quando questi non verifichino criteri di esclusione/interruzione

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

2012-07-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-05

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

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