Lung Diseases, InterstitialPhase 3NCT03820726
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
A Phase 3 study testing Nintedanib in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 121 sites in 15 countries.
Trial summary
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 complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Nintedanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 121 sitesin 15 countries
- Study dates
- 16 Apr 2019to 30 Aug 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Women of childbearing potential (WOCBP)1 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
Who cannot join
- 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.
- 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
- Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
- Previous enrolment in this trial. Further exclusion criteria apply.
Trial locations and contacts
121 sites in 15 countries.
121 sites in 15 countries
United States33 sites
Emory University
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21224
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, 33511
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
University of Chicago
Chicago, Illinois, 60637
Baylor University Medical Center
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Florida College of Medicine
Jacksonville, Florida, 32209
University of Kansas Medical Center
Kansas City, Kansas, 66160
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of California Los Angeles
Los Angeles, California, 90095
Loyola University Medical Center
Maywood, Illinois, 60153
Yale University School of Medicine
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
Creighton University
Omaha, Nebraska, 68124
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Oregon Clinic
Portland, Oregon, 97220
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
University of California Davis
Sacramento, California, 95817
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
Diagnostics Research Group
San Antonio, Texas, 78229
Medical Arts and Research Center (MARC)
San Antonio, Texas, 78229
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, 21286
Japan17 sites
Tosei General Hospital
Aichi, Seto, 489-8642
Kurume University Hospital
Fukuoka, Kurume, 830-0011
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, 670-8520
Kobe City Medical Center General Hospital
Hyogo, Kobe, 650-0047
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, 319-1113
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Tohoku University Hospital
Miyagi, Sendai, 980-8574
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Osaka Medical College Hospital
Osaka, Takatsuki, 569-8686
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
Tokyo Medical and Dental University Hospital
Tokyo, Bunkyo-ku, 113-8519
Toranomon Hospital
Tokyo, Minato-ku, 105-8470
JR Tokyo General Hospital
Tokyo, Shibuya-ku, 151-8528
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
France12 sites
HOP Avicenne
Bobigny, 93009
HOP Louis Pradel
Bron, 69677
HOP Côte de Nacre
Caen, 14033
CHRU Lille
Lille, 59037
HOP Nord
Marseille, 13915
HOP Arnaud de Villeneuve
Montpellier, 34295
HOP Pasteur
Nice, 06001
HOP Bichat
Paris, 75018
HOP Maison Blanche
Reims, 51092
HOP Pontchaillou
Rennes, 35033
HOP Civil
Strasbourg, 67091
HOP Bretonneau
Tours, 37044
Spain8 sites
Hospital Santa Creu i Sant Pau
Barcelona, 08026
Hospital de Galdakao
Galdakao, 48960
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital La Princesa
Madrid, 28006
Hospital Central de Asturias
Oviedo, 33011
Hospital Son Espases
Palma de Mallorca, 07120
Hospital de Canarias
San Cristóbal de La Laguna, 38320
Hospital Virgen del Rocío
Seville, 41013
Germany7 sites
Universitätsklinikum Bonn AöR
Bonn, 53105
Fachkrankenhaus Coswig GmbH
Coswig, 01640
Klinik Donaustauf
Donaustauf, 93093
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Medizinische Hochschule Hannover
Hanover, 30625
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Petrus-Krankenhaus
Wuppertal, 42283
Italy6 sites
A.O.U. Policlinico Vittorio Emanuele
Catania, 95124
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
Forlì, 47121
Azienda Ospedaliera Policlinico di Modena
Modena, 41100
A.O. San Gerardo di Monza
Monza, 20052
Poli Univ A. Gemelli
Roma, 00168
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, 53100
United Kingdom6 sites
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
St James's University Hospital
Leeds, LS9 7TF
Royal Brompton Hospital
London, SW3 6NP
Wythenshawe Hospital
Manchester, M23 9LT
University Hospital Llandough
Penarth, CF64 2XX
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Argentina5 sites
Centro Dr. Lazaro Langer S.R.L
Alberdi Sur, X5003DCE
Centro de Investigaciones Metabólicas (CINME)
C.a.b.a, 1056
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, B1602DQD
INSARES
Mendoza, M5500CCG
Instituto Médico de la Fundación Estudios Clínicos
Rosario, S2000DEJ
Poland5 sites
University Clinical Center, Gdansk
Gdansk, 80-214
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
Katowice, 40-752
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, 90-153
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, 01-138
Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
Zabrze, 41-803
Russia5 sites
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, 650002
Central Scientific Research Insitute of Tuberculosis
Moscow, 107564
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, 119992
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
Saint Petersburg, 197022
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
Yaroslavl, 150003
Belgium4 sites
ULB Hopital Erasme
Brussels, 1070
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530
Canada4 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Chile3 sites
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
Concepción, 4070038
Instituto Nacional del Tórax
Providencia, Santiago de Chile, 7500691
Centro de Investigación del Maule
Talca, 3465586
China3 sites
Peking Union Medical College Hospital
Beijing, 100730
Nanjing Drum Tower Hospital
Nanjing, 210008
The First Hospital of China Medical University
Shenyang, 110001
South Korea3 sites
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647
Seoul National University Bundang Hospital
Seongnam, 13620
Asan Medical Center
Seoul, 05505
About this study
Official title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
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 complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Nintedanib
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Bid
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib | Experimental | Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met. Receives: Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Adverse Events
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
Measured: From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start16 Apr 2019
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820726
- Sponsor's protocol ID
- 1199-0248
- Other IDs
- 2018-000525-32, 2018
- Status last verified
- Aug 2023
- First submitted
- 28 Jan 2019
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Publications
Wuyts WA, Bonella F, Chaudhuri N, Varone F, Antin-Ozerkis D, Song JW, Miede C, Dumistracel M, Coeck C, Cottin V. Continued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON. Lung. 2025 Jan 9;203(1):25. doi: 10.1007/s00408-024-00778-z.
PubMed 39789408
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
- ClinicalTrials.gov ID
- NCT03820726
- Acronym / sponsor ID
- 1199-0248
- Conditions
- Lung Diseases, Interstitial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nintedanib | Experimental | Drug: NintedanibPatients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Women of childbearing potential (WOCBP)1 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
Key exclusion criteria (4 listed)
- 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.
- 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
- Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
- Previous enrolment in this trial. Further exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibBid | Drug | Nintedanib |
Primary outcome
Number of Participants With Any Adverse Events
Time frame: From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39789408Wuyts WA, Bonella F, Chaudhuri N, Varone F, Antin-Ozerkis D, Song JW, Miede C, Dumistracel M, Coeck C, Cottin V. Continued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON. Lung. 2025 Jan 9;203(1):25. doi: 10.1007/s00408-024-00778-z.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Related trials for Lung Diseases, Interstitial
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
121 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nintedanib in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 121 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in United States, Japan, France, Spain, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Adverse Events (time frame: From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03820726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.